SOCIETY STATEMENT
ISUOG/ESGO Consensus Statement on
ultrasound-guided biopsy in gynecological
oncology*
D. Fischerova1,*, F. Planchamp2, J.L. Alcázar3,20, P. Dundr4, E. Epstein5, A. Felix6,7,
D 11 1
14
wit
-g
fers the advantage of accurate diagnosis while minimizing pro-
1e3
low risk of procedure-related complications enables the biopsy to
be performed in the outpatient setting. In addition, avoiding patient
referral to other physicians such as interventional radiologists can
istress and shorten the time
improvement of ultrasound
broad spectrum of minimally
and therapeutic procedures
* This article has been co-published with permission in Ultrasound in Obstetrics and Gynecology and the International Journal of Gynecological Cancer
velopment group (including all
t) have written the first draft of
mission.
anese G, Salvesen Haldorsen I,
nsus Statement on ultrasound-1048-891X/ª 2025 The Authors. Published by John Wiley & Sons Ltd on behalf of The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and by Elsevier
Inc. on behalf of the European Society of Gynaecological Oncology and the International Gynecologic Cancer Society. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/4.0/).The decision to develop this Consensus Statement was made jointly by ISUOG and ESGO. ISUOG and ESGO are non-profit societies. The de
authors) is collectively responsible for the decision to submit for publication. D. Fischerova (chair), U. Scovazzi and F. Planchamp (methodologis
the manuscript. All other contributors have actively given personal input, reviewed the manuscript, and have given final approval before sub
CITATION: This Consensus Statement should be cited as: ‘Fischerova D, Planchamp F, Alcázar JL, Dundr P, Epstein E, Felix A, Frühauf F, Garg
Jurkovic D, Kocian R, Lengyel D, Mascilini F, Stepanyan A, Stukan M, Timmerman S, Vanassche T, Yuan Ng Z, Scovazzi U. ISUOG/ESGO Conse
guided biopsy in gynecological oncology. Ultrasound Obstet Gynecol 2025. DOI: 10.1002/uog.29183.
https://doi.org/10.1016/j.ijgc.2025.101732cedure-associated morbidity. These diagnostic procedures are
often indispensable to inform patient management in situations
such as unresectable advanced gynecological cancer or suspected
disease recurrence. There are no specific guidelines available to
assist gynecologists in performing ultrasound-guided biopsies.
Real-time biopsy guidance using a transvaginal or transrectal
reduce healthcare costs, limit patient d
to initiation of appropriate treatment.
In parallel with the introduction and
diagnosis in gynecological oncology, a
invasive ultrasound-guided diagnostic
* Correspondence to; daniela.fischerova@vfn.cz (D. Fischerova)There has been increasing use of minimally invasive diagnostic
procedures in gynecological oncology in recent years, which con-The objective of this Consensus Statement is to assist clinicians, including gynecological sonographers, gynecological oncologists and radiologists, to
achieve the best standards of practice in ultrasound-guided biopsy procedures. ISUOG/ESGO nominated a multidisciplinary international group of 16 experts
who have demonstrated leadership in the use of ultrasound-guided biopsy in the clinical management of patients with gynecological cancer. In addition, two
early-career gynecological fellows were nominated to participate from the European Network of Young Gynae Oncologists (ENYGO) within ESGO and from
ISUOG. The group also included a patient representative from the European Network of Gynaecological Cancer Advocacy Groups. The document is divided
into six sections: (1) general recommendations; (2) image-guided biopsy (imaging guidance, sampling methods); (3) indications and contraindications; (4)
technique; (5) reporting; and (6) training and quality assurance. To ensure that the statements are evidence-based, the current literature was reviewed and
critically appraised. Preliminary statements were drafted based on this review of the literature. During a conference call, the whole group discussed each
preliminary statement, and a first round of voting was carried out. The group achieved consensus on all 46 preliminary statements without the need for
revision.
These ISUOG/ESGO statements on ultrasound-guided biopsy in gynecological oncology, together with a summary of the evidence supporting each
statement, are presented herein. This Consensus Statement is supplemented by detailed narrated videoclips presenting different approaches and
indications for ultrasound-guided biopsy, a patient leaflet, and an extended version which includes a detailed review of the evidence.
Keywords:
Ultrasound-guided biopsy; Gynecologic oncology; Consensus Statement
INTRODUCTION ultrasound approach allows close proximity to gynecological tu-
mors, ensuring high diagnostic adequacy and accuracy, while theF. Frühauf1, G. Garganese8,9, I. Salvesen Haldorsen10,21,
D. Lengyel12,22, F. Mascilini8, A. Stepanyan13, M. Stukan
T. Vanassche17, Z. Yuan Ng18, U. Scovazzi19
Available online xxx
ABSTRACT
The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG)
clinically relevant and evidence-based statements on performing ultrasound. Jurkovic , R. Kocian ,
,15, S. Timmerman16,
h the European Society of Gynaecological Oncology (ESGO) jointly developed
uided biopsies in gynecological oncology.
has been developed (Table 1). Ultrasound-guided diagnostic pro-
cedures include core-needle (tru-cut) biopsy and fine-needle
(including biopsies of, for example, liver, kidney, pancreas, spleen)
to high-quality systematic reviews, meta-analyses and validating
cohort studies, although studieswith lower levels of evidencewere also
evaluated. The search strategy excluded editorials, letters and case
reports. The reference list of each identified article was reviewed for
other potentially relevant articles. The results of the literature search
were distributed to the whole group, including electronic full-text
versions of each article. One of the authors (F.P.) providedmethodology
support throughout the process, but did not participate in the voting on
the consensus statements. Thus, there were 18 voting participants.
Each lead author, following discussion with their working group,
was responsible for drafting preliminary statements after a review
Table 1 Image-guided procedures in gynecological oncology
Fischerova D., et al. IJGC
SOCIETY
STATEM
ENTdo not address the pelvic organs full.12e16 Moreover, the trans-
vaginal approach is rarely included in the armamentarium of ra-
diologists. Scientific data from radiologic departments suggest
underestimation of the applicability of transvaginal ultrasound-
guided biopsy in a gynecological oncology setting, with limited case
numbers over a long period of time.17
The lack of information on best practice in ultrasound-guided
biopsy in gynecology and the growing need for this service in every
gynecological oncology center led to the initiation of the process
that produced this Consensus Statement. The objective of this work
is to assist clinicians, including gynecological sonographers, gy-
necological oncologists and radiologists, to achieve the best stan-
dards of practice in diagnostic (biopsy) procedures. It includes the
following sections:
1. General recommendations
2. Image-guided biopsy (imaging guidance modalities, adequacy, accu-
racy, diagnostic yield and complications of sampling methods)
3. Indications and contraindications
4. Technique
5. Reporting
6. Training and quality assurance
A comprehensive summary of published data for all six sections
is provided in the extended version of this Consensus Statement
(Appendix S1). The technique is demonstrated in Videoclips S1eS3
and the indications for biopsy in Videoclip S4. A sample patient
leaflet is also provided to aid counseling and communication with
patients (Appendix S2).
Supplementary video related to this article can be found at
https://doi.org/10.1016/j.ijgc.2025.101732.
RESPONSIBILITIES
The present series of statements represent a consensus of the
authors regarding their currently accepted approaches for ultra-
sound-guided biopsy, based on the available literature and evi-
dence. Any clinician applying or consulting these statements is
expected to use independent medical judgment in the context of
individual clinical circumstances to determine all patients’ care and
treatment. These statements are presented without any warranty
regarding their content, use or application and the authors disclaim
any responsibility for their application or use in any way.aspiration. Any ultrasound-guided intervention changes the ultra-
sound modality from a risk-free method to an intervention that
carries risk and therefore needs its own clear standard operating
procedure. Given an appropriate indication and careful execution,
these procedures are well-tolerated by patients and less risky and
costly than surgical procedures.4e11 Until recently, common
practice has been for ultrasound-guided procedures to be per-
formed mainly by interventional radiologists. There have been many
useful guidelines published on the topic of interventional ultrasound
using the percutaneous ultrasound-guided approach. However,
these guidelines focusing on intra-abdominal interventionsVolume XXX 
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These consensus statements on ultrasound-guided biopsy in gy-
necological oncology were developed using an eight-step process,
chaired by Professor Daniela Fischerova (Figure S1 in Appendix S1).
Aiming to assemble a multidisciplinary international group, the
International Society of Ultrasound in Obstetrics and Gynecology
(ISUOG) and the European Society of Gynaecological Oncology
(ESGO) nominated 16 experts who have demonstrated leadership in
the use of ultrasound-guided biopsy in the clinical management of
patients through research, administrative responsibilities and/or
committee membership. Altogether, six gynecologists with special
interest in ultrasonography, one radiologist, two pathologists, one
cardiologist and six gynecological oncologists were included. In
addition, two early-career gynecological fellows with special in-
terest in ultrasound-guided biopsy were nominated to participate
from the European Network of Young Gynae Oncologists (ENYGO)
within ESGO and from ISUOG, to form the final working group of 18
participants. The participants did not represent the societies from
which they were elected but were asked to base their decisions on
their own experience and expertise. A patient representative from
the European Network of Gynaecological Cancer Advocacy Groups
(ENGAGE Co-Chair) was also included in the group.
An initial conference call including the whole group was held to
facilitate introductions, as well as to review the purpose and scope of
the Consensus Statement. The proposeddocumentwas divided into six
sections, each with a lead author and a working group according to
previously expressed interests and expertise. To ensure that the
statements were evidence-based, the current literature was reviewed
and critically appraised. A systematic literature review of relevant
studies published between technique inception and 2023 was carried
out using the MEDLINE database (Appendix S3). The literature search
was limited to publications in the English language. Priority was given
Procedure Type of intervention
Diagnostic Fine-needle aspiration
Core-needle (tru-cut) biopsy
Diagnostic/therapeutic Drainage of fluid collections*
Paracentesis
Thoracocentesis
Palliative Insertion of permanent peritoneal or
thoracic catheter
* Fluid collections can occur in different clinical scenarios, including abscess,
lymphocele, peritoneal pseudocyst, seroma and hematometra following tra-
chelectomy or brachytherapy.https://doi.org/10.1016/j.ijgc.2025.101732 2
Fischerova D., et al. IJGC
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Tof the relevant literature. These were then circulated to the entire
group prior to a second conference call. During the second con-
ference call, the whole group discussed each preliminary state-
ment, and a first round of binary voting (agree/disagree) was
carried out for each potential statement. All 18 participants took
part in each vote, but they were permitted to abstain from voting if
they felt they had insufficient expertise to agree/disagree with the
statement or if they had a conflict of interest that could influence
their vote. Statements would be removed if a consensus among
group members was not reached. The voters had the opportunity to
provide comments or suggestions together with their votes, which
would require revision of the statement and a second round of
voting. The group achieved consensus on all 46 preliminary
statements without the need for revision and another round of
voting. Thus, based on the results of the first round of voting, the
statements were finalized. In the main text of this Consensus
Statement, we present a summary of the supporting evidence, the
finalized series of statements, and their levels of evidence and
grades as described in Appendix S4. The extended version of this
Consensus Statement, including a detailed evidence review, is
provided in Appendix S1.
RESULTS
General recommendations
The purpose of performing minimally invasive biopsy procedures in
gynecology is to obtain a representative tissue sample from sus-
pected pathological processes to enable a morphological exam-
ination.11,17e20 These biopsy procedures are particularly useful for
patients not eligible for more invasive interventions or to accelerate
the process from diagnosis to therapy without the need for a period
of recovery.7,18 In addition, in the era of personalized medicine,
obtaining biopsy samples from gynecological cancers, either pri-
mary or recurrent disease, has become increasingly important to
obtain material for predictive testing and to plan subsequent tar-
geted therapy.5,11,21,22 Evidence indicates that repeated biopsies at
different times are well tolerated by patients.4,5,23 The indication for
biopsy, performance and reporting of biopsy, and final interpreta-
tion of results according to the clinical and imaging findings require
multidisciplinary team expertise. This was recently highlighted by a
National Cancer Institute panel, which reported that improving the
communication between radiologists, oncologists and pathologists
increases the probability of obtaining fit-for-purpose samples for
pathological diagnosis and/or genomic analysis.24 Multidisciplinary
team discussion is also required if procedure-related risk is
deemed to be high or in the event of inconclusive biopsy results, to
discuss possible alternative diagnostic options.25
Statement 1: Image-guided tumor biopsy forms an integral
component of the individualized treatment of gynecological can-
cers, especially in the context of disseminated disease, recurrence
or the presence of surgical contraindications.

 Level of evidence: 3b

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 2: Expertise and effective communication within a
multidisciplinary team are essential to determine a proper indica-
tion and technical execution of an ultrasound-guided biopsy, toVolume XXX 
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imen and the accuracy of pathology reporting, and to optimize the
integration of biopsy results with clinical and imaging findings.

 Level of evidence: 3b

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Image-guided biopsy (image-guidance modalities, adequacy,
accuracy, diagnostic yield and complications of sampling
methods)
Image-guided biopsy aims to sample a target tissue using a guided
approach, by ultrasound or other imaging technology. Real-time
biopsy guidance is essential to optimize tissue sample acquisition.
Obtaining biopsy specimens which are suitable for histopathological
and molecular analysis should be quick and minimally invasive, and
should pose a low risk of procedure-related complications. Ideally,
the procedure should be performed in the outpatient setting, to
avoid delays in initiating appropriate treatment, while also ensuring
diagnostic accuracy and safety.18,19,26
Image-guidance modalities
Ultrasound offers many benefits, including a low rate of false-
negative biopsies and low rate of complications, wide availability,
short procedure time, lack of ionizing radiation, portability and
relatively low cost (Table S1 in Appendix S1).27 Crucially, it allows
real-time intraprocedural visualization of the biopsy needle and
target lesion, dynamic multiplanar vision (i.e. the ability to guide the
procedure in almost any anatomical plane), high soft-tissue reso-
lution (especially in the pelvis in the case of endovaginal/endoanal
probe insertion) and the use of power or color Doppler, which are
essential to achieve safe access to target lesions.18,26e30 Doppler
examination helps to visualize blood vessels and define the most
suitable part of the tumor for biopsy. Alternatively, contrast-
enhanced ultrasound can be used to evaluate the presence of
vascularity as a sign of tumor tissue viability, especially in large
intra-abdominal tumors with areas of necrosis.21,31,32 Ultrasound-
guided procedures can be done utilizing a variety of transducers
(endocavitary, convex array, linear array and sector, among others),
allowing different approaches for biopsy-needle insertion (percu-
taneous, transvaginal, transcervical, transrectal) (Figure 1, Video-
clips S1eS3).18,26,29 The safest path to the target lesion should be
selected by avoiding non-target organs and blood vessels. For bi-
opsy of pelvic lesions, the transvaginal approach is preferred for its
good diagnostic yield and safety profile, and should be considered
the first choice, even when other approaches are feasible.17,18
Within the pelvis, the transrectal biopsy approach offers a short
distance to the target and visualization similar to that of the
transvaginal approach, but is less comfortable for patients and
carries the potential risk of bacterial contamination.33e35 It is
crucial to explain carefully the reasons for recommending a
transrectal biopsy approach and to obtain the patient’s explicit
consent before this approach is used. In the transcervical biopsy
approach, for ultrasound guidance, the probe is placed in the
rectum or on the abdomen, while the biopsy needle is inserted
transcervically through the endocervical canal and advanced
through the uterine cavity (transcavitary) to reach suspected uterine
tumors without passing through the uterine serosa. This provideshttps://doi.org/10.1016/j.ijgc.2025.101732 3
iops
obe
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), th
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Fischerova D., et al. IJGC
SOCIETY
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ENTthe advantage of an ‘in-organ’ biopsy, which is important to
minimize the risk of spread of malignant tumor cells along the
needle-biopsy tract.36 The adequacy of biopsy using a percuta-
neous approach, with or without a needle guide, is highly depen-
dent on adequate acoustic conditions and the location of the target
lesion. The main limitations of percutaneous ultrasound guidance
are related to the possible difficulty in visualizing the tumor target
or needle tip. This may occur when the distance between the target
and the ultrasound probe is large, such as: in obese subjects or in
the presence of high-volume ascites; when there is acoustic
shadowing due to intestinal air or solid tissue, such as bone or
calcified areas; or when the lesion is inaccessibile due to critical or
vulnerable anatomical structures.7,37
When visualization at ultrasound examination is problematic,
contrast-enhanced ultrasound, or coregistration (fusion imaging) of
Figure 1 Illustration of different approaches for performing core-needle b
needle is inserted into a metal needle guide attached to the endocavitary pr
(b). (c,d) Percutaneous approach, using the free-hand technique: the biops
ultrasound beam (c); the biopsy is taken from the infiltrated abdominal wa
ultrasound probe placed in the rectum or on the abdomen for guidance (e
transcavitarily (in-organ biopsy) (f). UMT, uterine mesenchymal tumor. Seereal-time ultrasound with acquired images from computed to-
mography (CT), magnetic resonance imaging (MRI) or positron
emission tomography (PET), may be considered, although these
require specialized software and equipment and are less widely
used.21,38e40
The next most commonly used imaging method after ultrasound
is CT.41e43 It is a safe procedure with good diagnostic performance
(accuracy estimates: 82e100%), but with major limitations related
to the low tissue contrast, the need for patient fasting, the exposure
to radiation and the risk of contrast-agent-related toxicity.43 MRI
guidance, despite providing good soft-tissue resolution and having
no risks associated with radiation exposure, is still used only rarely,
as it requires special non-magnetic equipment and experienced
operators.44 PET in combination with CT or MRI has also been
proposed as guidance for biopsy; however, this is rarely used in
gynecological practice.45,46
Biopsy methods
Two main sampling techniques are commonly used in gyneco-
logical oncology practice, applied to different cases according to the
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components, the clinical condition of the patient and other fac-
tors.47,48 The first, core-needle biopsy (also known as tru-cut bi-
opsy), uses a side-cutting or end-cutting needle to provide tissue
samples suitable for histological analysis and immunochemistry
(Figure 2, and Figures S2eS4 in Appendix S1). The second, fine-
needle aspiration, also commonly referred to as fine-needle aspi-
ration cytology or biopsy, yields cells or, rarely, small tissue frag-
ments, which are sufficient for cytological examination and may
sometimes also be used for complementary studies if there is
enough material (Figure 3, and Figure S5 in Appendix S1).
The use of biopsy specimens can also be extended to other
clinical and research applications, such as molecular testing (e.g.
complex genomic profiling by next-generation sequencing) and
other analyses (e.g. assessment of stromal microenvironment)
y. (a,b) Transvaginal or transrectal approach: the biopsy device with biopsy
(a); the biopsy is taken from an infiltrated pelvic parietal (iliac) lymph node
eedle is inserted along the longitudinal axis of the probe, guided by the
ister Mary Joseph’s nodule) (d). (e,f) Transcervical approach: using an
e biopsy needle is visible approaching the lesion transcervically and
o Videoclips S1eS3.(Table 2).
Diagnostic performance of image-guided biopsy is evaluated
using the following parameters: adequacy (sufficient material for
diagnosis), accuracy (concordance with final pathology), safety (low
risk of complications (Table S2 in Appendix S1)) and grading of
diagnostic yield (detection rate and impact on management). The
literature shows no substantial differences between core-needle
biopsy and fine-needle aspiration with respect to the adequacy of
specimens obtainable (tissue block from core-needle biopsy vs
cytological smear from fine-needle aspiration, 84e100% vs
74e100% of procedures provide adequate material) and their
accuracy for distinguishing between benign and malignant tumors
(73e100% vs 73e99% accuracy) (Tables S3 and S4 in Appendix
S1).7,18e20,49e60
Core-needle biopsy is preferred, because it allows a tissue
sample to be obtained and thus more accurate assessment of the
histological type of the tumor (Figure 3, and Figures S3 and S4 in
Appendix S1). This is due in particular to the fact that core-needle
biopsy allows assessment of tumor architecture and the relation-
ship between tumor and stroma, which is essential for correct
https://doi.org/10.1016/j.ijgc.2025.101732 4
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diagnosis in some tumors.61 Knowledge of the relationship be-
tween tumor and stroma is necessary in the evaluation of the
biological nature of tumors such as low-grade serous carcinoma
and serous borderline tumor.62 Diagnosis of some mesenchymal or
fibrotic lesions may be difficult or impossible from fine-needle
aspiration samples, due to the low yield of tumor cells.63 Moreover,
a sufficient amount of material is needed for subsequent in-
vestigations, especially molecular tests.
Both techniques appear to be acceptable with regard to safety,
with an overall rate of major complications of < 1.5% (Tables
S2eS4 in Appendix S1).7,18,19,48,64,65 The most frequently
encountered complications are minor, and include procedure-
related pain or discomfort and self-limiting biopsy-related
Figure 3 Comparison of fine-needle aspiration (FNA) (a,b) and core-needle bi
smear obtained from ascitic fluid (MayeGrünwaldeGiemsa stain) from a wom
carcinoma cells from the ascitic fluid (Papanicolaou stain). (c) Low-power view
infiltrated by high-grade serous carcinoma. (d) High-power view of carcinoma ce
(e) Immunohistochemical staining with p53 positivity in all cells, with strong an
Figure 2 Illustration of core-needle biopsy (CNB) mechanism, with a side-c
should be positioned at the edge of or inside the lesion before firing, depending
Volume XXX 
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detection rate, the minimum amount of tissue required for suffi-
cient analysis and possible complications (e.g. bleeding, in-
fections, organ injury, vasovagal reaction and tumor seeding) are
discussed in detail in the extended version of this document
(Appendix S1).
It has been reported that increasing the biopsy core length
(greater penetration depth), needle size (wider needles) and number
of cores obtained (higher number of passes) directly influences the
cancer detection rate, but may also lead to a greater risk of trauma
and bleeding.67e69 Data suggest that, for the molecular testing of
epithelial tumors, at least two 10-mm-long cylinders using a needle
that is 18-G or wider should be obtained (Figure 3).70,71 This amount
opsy (CNB) (cee) specimens. (a) Macroscopic appearance of the cytological
an with findings suggestive of ovarian cancer and (b) high-power view of
of CNB specimen of the omentum (hematoxylin and eosin (H&E) staining)
lls with hyperchromatic and pleomorphic nuclei, and mitosis (H&E staining).
d diffuse nuclear expression compatible with high-grade serous carcinoma.
utting needle used to obtain biopsy sample. The tip of the biopsy needle
on the size of the lesion and the location of viable area(s) of tumor identified.
https://doi.org/10.1016/j.ijgc.2025.101732 5
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Fischerova D., et al. IJGC
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ENTTable 2 Comparison between fine-needle aspiration and core-needle b
Fine-needle aspiration
Needle size 20e25 G (outer diameter from 0.9 mm
Sample collection Aspiration needle, often connected t
whose plunger can be used to apply
pressure to aspirate the specimen
Sample type Aspiration of cellular material or fluid
or effusion
Material preservation/
processing
The collected material is usually exp
multiple glass slides, creating smears
container with a fixative, such as form
alternatively, medium for liquid-based
be used
Staining The glass slides are typically stained
specialized dyes (MayeGrünwaldeG
Papanicolaou stain) or H&E
Microscopic examination On microscopy, the pathologist evalu
morphology, structure and other cha
reach a diagnosis
Advantages Possibility of multiple passes in vario
for each sample
Flexibility in specimen preparationof tissue is also likely to be sufficient for any other diagnostic pur-
pose. For uterine mesenchymal tumors, the diagnostic yield reaches
a plateau at three samples and does not appear to be improved by
increasing the needle width greater than 18 G (Figure S3 in Appendix
S1).72e74 Effort should be made to target the most heterogeneous
area within the mesenchymal tumor tissue to increase diagnostic
yield. When lymphoma is suspected, core-needle biopsy may be
considered as an alternative to the reference standard which is
complete excision of the lymph node.26,75,76 In these cases, a similar
strategy, using an 18-G needle with at least three passes through
different regions of the lymph node or different lymph nodes, is
recommended (Figure S4 in Appendix S1).77
Given the advantages of core-needle biopsy in gynecological
oncology, the main emphasis in the following sections will be on
this technique, although the indications, contraindications, biopsy
technique, reporting and training are very similar to those for fine-
needle aspiration.4,11,18e21
Statement 3: Image-guided biopsy is a minimally invasive
technique, which provides a safer alternative to surgery. It is
effective in obtaining an adequate tissue sample for an actionable
pathological result which can be used to guide treatment.
Collection of fresh and intact cells
Lower complication rate
Low level of pain and rare need for local
Less expensive
Limitations Limited tissue architecture
Lower yield for fibrotic tissue lesions
Difficult on cytological smears to disting
borderline tumor from carcinoma
Cytological specimen processing may b
challenging; expertise required
For most lesions, lower sensitivity, spec
accuracy
* Differences between fine-needle aspiration and core-needle biopsy are mainly due
staining; NGS, next-generation sequencing.
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Core-needle biopsy
o 0.5 mm)* 14e18 G (outer diameter from 2.1 mm to 1.3 mm)
syringe
gative
Hollow needle with a spring-loaded cutting action,
integrated in an automated or semi-automated gun
m a lesion Cylindrical/semicylindrical core of tissue from a
solid mass
d onto
r into a
in;
tology can
The cylindrical/semicylindrical core of tissue from a
solid mass is typically preserved in a fixative
solution, most commonly formalin, and after
fixation, the tissue core is processed to embed it in
paraffin
th various
sa stain;
The glass slides are typically stained with H&E;
immunohistochemistry is commonly used
s cell
teristics, to
On microscopy, the pathologist assesses tissue
architecture, cell morphology and other
characteristics; this detailed examination aids in
making a diagnosis
directions Larger intact tissue sample with preserved
architecture
Tissue for immunohistochemistry and ancillary
 Level of evidence: 3a

 Grade of statement: B

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 4: Among all imaging methods, ultrasound should
be considered the first choice for guidance of biopsy, because it
provides real-time imaging, is versatile and allows a multiplanar
view.

 Level of evidence: 3b

 Grade of statement: B

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 5: Ultrasound-guided biopsy can be performed with
different approaches (transvaginal, transcervical, transrectal and
percutaneous), using different transducers (endocavitary, convex
array and linear array) according to the safest path to the target and
its best visualization.

 Level of evidence: 4

 Grade of statement: B

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
anesthesia
studies (e.g. NGS)
Higher yield for fibrotic tissue lesions
For most lesions, higher sensitivity, specificity and
accuracy than fine-needle aspiration to make a
definitive diagnosis
uish e.g.
e
ificity and
More expensive
Slightly higher level of pain and potential need for
local anesthesia
Higher complication rate
Slightly longer tissue fixation and processing time
to the technique itself, rather than needle gauge. H&E, hematoxylin and eosin
https://doi.org/10.1016/j.ijgc.2025.101732 6
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Fischerova D., et al. IJGC
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TStatement 6: Doppler examination may help to define the most
suitable viable part of the tumor for biopsy. Alternatively, contrast-
enhanced ultrasound can be used.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 7: In poorly visualized targets or when there are
inconclusive findings with B-mode ultrasound, alternative imaging
techniques to guide the biopsy, such as contrast-enhanced ultra-
sound or novel image fusion methods, can be employed.

 Level of evidence: 3a

 Grade of statement: C

 Consensus: yes, 78% (nZ 14); no, 0% (nZ 0); abstain, 22% (nZ 4)
Statement 8: Other imaging guidance (CT, MRI or PET/CT) may
be chosen according to lesion accessibility and/or to overcome
suboptimal acoustic conditions.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 9: Two sampling techniques can be used for image-
guided biopsy: core-needle biopsy and fine-needle aspiration.

 Level of evidence: 3a

 Grade of statement: B

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 10: The choice between core-needle biopsy and
fine-needle aspiration depends on the specific clinical situation.
However, core-needle biopsy is preferable to fine-needle aspiration,
as it allows tumor tissue to be obtained for biopsy examination,
including ancillary methods, and it provides a larger volume of
tumor tissue for multiple analyses, including molecular methods.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 11: In order to ensure adequacy, high accuracy,
diagnostic yield and safety of core-needle biopsy, it is recom-
mended to obtain at least two 10-mm-long cylinders using a
needle that is 18 G or wider. This provides enough tissue for
diagnostic, molecular and genetic purposes for epithelial tumors
and their metastases (peritoneal, lymphatic, parenchymal). At least
three such cores are recommended for uterine mesenchymal tu-
mors and lymphomas.

 Level of evidence: 3b

 Grade of statement: C

 Consensus: yes, 89% (nZ 16); no, 0% (nZ 0); abstain, 11% (nZ 2)
Indications and contraindications
It is essential to ensure proper patient selection and valid clinical
indication prior to image-guided biopsy. The main indications and
contraindications of core-needle biopsy are shown in Table 3 andVolume XXX 
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biopsy are demonstrated in different clinical cases in Videoclip S4.
The risk of the diagnostic procedure should not outweigh the
potential benefits.13,15 Studies investigating core-needle biopsy in
gynecology demonstrated a low rate of major bleeding complica-
tions (< 1.5%) regardless of the approach.18e20 Obtaining biopsies
from richly vascularized intraperitoneal tumors and/or abdominal
visceral organs is associated with an increased risk of complica-
tions.78,80 Patients with an elevated risk of bleeding include those
with known bleeding disorders or prior bleeding complications, or
those on anticoagulation or antiplatelet treatment.78 For procedures
with high risk of bleeding and/or patients at elevated general risk of
bleeding, a routine screening coagulation panel is recommended,
including hemoglobin, platelet count, prothrombin time (PT) and/or
international normalized ratio (INR), and activated partial throm-
boplastin time (aPTT) (Table 4).78 In some patients, additional tests
may be required, such as anti-Xa testing in patients receiving
heparin and fibrinogen level in patients with cirrhosis. In patients
with bleeding tendencies or with a history of severe bleeding,
normal PT and aPTT cannot rule out all coagulation disorders. If
indicated, the preprocedural preparation should include appropriate
counseling by a specialist to address the risks of bleeding and
thromboembolism. More detailed information, for when there is
comorbidity, can be found in the consensus guidelines of the So-
ciety of Interventional Radiology.78
For patients on anticoagulation and/or antiplatelet therapy, the
decision whether to withhold the therapeutic agents prior to biopsy
and, if so, for what length of time depend on the patient’s overall
clinical status and thromboembolic and bleeding risks and on the
procedure-associated bleeding risk.78,81 If the procedural bleeding
risk is low, most anticoagulant/antiplatelet drugs can be continued.
In such a situation, the patient’s thromboembolic risk does not
influence the clinical decision.82 Conversely, for patients at elevated
risk of bleeding and for procedures with high risk of bleeding,
additional factors need to be considered, including the type of
anticoagulant and antiplatelet agents used (Table 5).80,83e86 The
final decision regarding the periprocedural management of anti-
coagulation, including the use of bridging therapy with low-mo-
lecular-weight heparin, should take into account and balance all the
above risks.87 High procedural risk, elevated bleeding risk, difficulty
of access to the target lesion and other situations which increase
biopsy-related risk should be noted prior to the procedure. Such
procedures should be performed by the most experienced opera-
tors, and the use of a thin core needle (18 G) should be considered
to minimize tissue trauma.
Statement 12: Core-needle biopsy should be performed if it is
clinically meaningful for the patient’s management. Indications
include: (1) to determine primary origin in patients with inoperable/
non-resectable disease or unknown primary cancer; (2) to stage
disease; (3) to identify residual or suspicious recurrent disease; (4)
to establish the nature and histological diagnosis of suspicious
uterine mesenchymal tumors; (5) to investigate suspicious cervical,
vaginal or endometrial lesions and others; and (6) for targeted
treatment including research purposes.

 Level of evidence: 2b

 Grade of statement: B

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)https://doi.org/10.1016/j.ijgc.2025.101732 7
Table 3 Indications and contraindications for core-needle biopsy in gynecology/gynecological oncology
l c
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Fischerova D., et al. IJGC
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Primary inoperable/non-resectable genital tumor (mostly ovarian/tuba
Cancer of unknown primary origin including metastases to genital or
Uterine mesenchymal tumor with atypical appearance on ultrasound
Suspicious cervical or vaginal lesion (or, rarely, endometrial lesion if
Suspicion of recurrence of genital tumor
Research biopsy and molecular profiling (including de novo biopsy in
Staging purposes e inconclusive imaging findings
Contraindications for core-needle biopsyy
Thrombocytopenia
Biopsy with low procedure-related risk of bleeding when patient has
Biopsy with high procedure-related risk of bleeding when patient has
Antiplatelet therapy (ongoing)zStatement 13: There are no specific absolute contraindications
to core-needle biopsy in gynecology/gynecological oncology.
However, risks and benefits should be balanced, considering the
patient’s comorbidities and medications, difficulty of access to the
target lesion and risk of tumor spillage.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 14: Any decision about periprocedural management
should be based on a thorough assessment of the patient’s overall
clinical status, including thromboembolic and bleeding risks and
the procedure-associated risks.
Coagulative disorderx
History of procedural bleeding or known bleeding tendency
Hemophilia
Abnormal coagulation screening tests (prothrombin time or activated pa
Anticoagulation therapy (ongoing)
Vitamin K antagonists{
Biopsy with low procedure-related risk of bleeding when patient has ele
Biopsy with high procedure-related risk of bleeding when patient has el
Direct oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban
Difficult access to the lesion
Risk of tumor spillage (upstaging of well-encapsulated mass due to iatro
Absence of qualified operator, inadequate technical equipment, patient
* In descending order based on frequency; core-needle biopsies for these indicatio
visceral organs (e.g. liver, kidneys) and biopsies of hypervascular lesions (color score
y Predominantly relative contraindications that can be controlled by periprocedural m
basis; there are no absolute contraindications specific to core-needle biopsy in gynec
z Risks and benefits of interruption of antiplatelet therapy should be considered, and
specialist) should be sought. In general, the following algorithm is recommended: if antip
biopsy; if continued antiplatelet therapy is indicated, and patient is undergoing single an
therapy is indicated, and patient is undergoing dual antiplatelet therapy, the risk of
discussed with the treating specialist. See Table 5 for further details.
x Periprocedural advice from hematologist should be sought.
{ See Table 5 for further details.
** General absolute contraindications of any interventional procedure; in the event of p
there are concerns that can be addressed. INR, international normalized ratio; PLT, pl
Volume XXX 
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s (mostly secondary ovarian tumors)
magnetic resonance imaging
er methods of biopsy inapplicable)
se of disease progression or recurrence)
vated risk (PLT  30  109/L)
evated risk (PLT  50  109/L)
 Level of evidence: 3b

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 15: Clinicians performing a biopsy should be aware
of potential complications and routinely implement strategies to
avoid or minimize them.

 Level of evidence: 2b

 Grade of statement: B

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 16: Regarding procedure-related risk of major
bleeding, core-needle biopsies in gynecology/gynecological
rtial thromboplastin time)
vated risk (INR  2.0)
evated risk (INR  1.5)
){
genic intervention)
refusal or uncooperative patient**
ns are usually low-risk procedures, while percutaneous biopsies of abdominal
, 4) are considered high-risk procedures.
anagement of thrombotic and bleeding risks, or considered on a case-by-case
ology/gynecological oncology.
periprocedural advice of treating specialist (hematologist/cardiologist/coagulation
latelet therapy can be interrupted safely, stop antiplatelet therapy 5 days prior to
tiplatelet therapy, low-risk procedures can be performed; if continued antiplatelet
interrupting therapy is often high, and periprocedural management should be
atient refusal, always check the patient’s reasons carefully and explore whether
atelet count.
https://doi.org/10.1016/j.ijgc.2025.101732 8
Table 4 Current recommendations for screening coagulation panel and thresholds to perform biopsy procedure, in order to minimize risk of major
d risks of bleeding
ing
tin
Fischerova D., et al. IJGCbleeding complications, according to procedure-related and patient-relate
Patient with low risk of bleed
Low procedure-related
risk of bleeding*
PT/INR, aPTT, Hb, PLT not rou
recommendedoncology are considered to be low risk (risk of major bleeding
complication < 1.5%). Percutaneous biopsies of abdominal visceral
organs (e.g. liver, kidneys) as well as any biopsy of hypervascular
lesions (color score, 4) are considered high-risk procedures.
High procedure-related
risk of bleeding*
PT/INR, aPTT, Hb, PLT recomme
routinely
Thresholds (correct to)z:
INR < 1.5
PLT > 50  109/L
* Biopsies for indications specified in Table 3 are usually low-risk procedures, whi
biopsies of hypervascular lesions (color score, 4) are considered high-risk procedures
y In addition, anti-Xa testing in patients receiving heparin and assessment of fibrino
z Patient INR/PLT level should be corrected until threshold is met. aPTT, activated part
platelet count; PT, prothrombin time.
Table 5 Recommendations for adjustment to specific anticoagulant and an
Anticoagulant or antiplatelet agent Biopsy procedure wi
bleeding
Vitamin K antagonists (warfarin,
phenprocoumon, acenocoumarol)
Consider continuation
exclude supratherapeu
INR < 2.0); if withheld
same day as procedu
LMWH (enoxaparin, nadroparin,
tinzaparin, dalteparin)
Do not withhold, avoid
levels (perform biopsy
dose of LMWH)
Direct oral anticoagulants (dabigatran,
rivaroxaban, apixaban, edoxaban)y
Do not withhold, avoid
levels (perform biopsy
dose of direct oral ant
Skipping a single dose
the biopsy can be con
Aspirin Do not withhold
Ticagrelor Do not withhold
Prasugrel Do not withhold
* Warfarin will take 5e10 days to attain a full anticoagulant effect, as measured by a
‘bridging therapy’ in patients at high risk of thromboembolism.
y For details on specific anticoagulant agents refer to current guidelines.78,81
z Patients with impaired renal function may require longer; duration can be individu
Volume XXX 
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 2025Patient with elevated risk of bleeding
ely PT/INR, aPTT, Hb, PLT should be consideredy
Thresholds (correct to)z:
 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
INR < 2.0
PLT > 30  109/L
nded PT/INR, aPTT, Hb, PLT recommended routinelyy
Thresholds (correct to)z:
INR < 1.5
PLT > 50  109/L
le percutaneous biopsies of abdominal visceral organs (e.g. liver, kidneys) and
.
gen level in patients with cirrhosis.
ial thromboplastin time; Hb, hemoglobin; INR, international normalized ratio; PLT,
tiplatelet treatments in patients undergoing biopsy procedure
th low risk of Biopsy procedure with high risk of
bleeding
, check INR to
tic levels (target
, to reinitiate on
re
Withhold for 5 days until target INR
< 1.5; consider bridging only in selected
cases with very high risk of thrombosis;
resume on day after procedure in the
absence of bleeding complications*
peak plasma
 6 h after last
Withhold for 12 h for prophylactic doses
of LMWH, and 24 h for therapeutic doses
of LMWH
Consider checking anti-Xa if renal
function impaired
peak plasma
 6 h after last
icoagulant)
before and after
sidered
Withhold 1e3 days before procedure
(depending on agent and renal functionz)
Resume 1e2 days after procedure in the
absence of bleeding complications
Withhold 3e5 days before biopsy, then
resume on day after procedurey
Withhold 5 days before biopsy; resume
on day after procedure
In patients with dual antiplatelet therapy
(aspirin þ ticagrelor), discuss with
treating cardiologist/physician
Withhold 5 days before biopsy; resume
on day after procedure
In patients with dual antiplatelet therapy
(aspirin þ prasugrel), discuss with
treating cardiologist/physician
n international normalized ratio (INR) > 2.0; therefore, consider use of a heparin
alized. LMWH, low-molecular-weight heparin.
https://doi.org/10.1016/j.ijgc.2025.101732 9
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Statement 17: Regarding patient-related bleeding risk, women
with coagulative disorders or on anticoagulative therapy and those
with thrombocytopenia or on antiplatelet therapy are considered at
elevated risk of major bleeding.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 18: Withholding and restarting anticoagulant and/or
antiplatelet drugs should be carried out according to recommen-
dations of relevant specialists. The patient’s individual thrombo-
embolic risk should also be taken into consideration.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 19: For procedures with low risk of bleeding
planned in patients with no or minimal bleeding risk factors, a
screening coagulation panel is not required. These procedures
can be performed by adequately trained sonographers (level II
minimum).
Statement 21: For all procedures with high risk of bleeding,
recommended laboratory thresholds to minimize the risk of major
bleeding complications are INR < 1.5 and PLT > 50  109/L.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 22: For patients at elevated risk of bleeding un-
dergoing procedures with low risk of major bleeding complications,
laboratory thresholds are INR < 2.0 and PLT > 30  109/L. An-
tiplatelet therapy can continue. Anticoagulant therapy can continue
in most cases.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 89% (nZ 16); no, 0% (nZ 0); abstain, 11% (nZ 2)
Technique
Ultrasound-guided biopsy should be performed only by a physician
familiar with the indications, contraindications, limitations, typical
findings and possible side effects of the procedure. The physician
(30
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Fischerova D., et al. IJGC
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 Level of evidence: 3a

 Grade of statement: C

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 20: For procedures with high risk of bleeding or in
patients at elevated risk of bleeding, a screening coagulation panel
(platelet count, hemoglobin, INR/PT and aPTT) is routinely recom-
mended. These procedures should be performed by expert
sonographers (level III).

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Figure 4 Instruments needed for core-needle biopsy: (1) biopsy needle
protective probe cover; (5) anesthetic gel; (6) analgesia suppository; (7) lab
antiseptic cleaning agent; (10) sterile gloves; (11) automated core-needle d
anesthetic; (14) biopsy needle (20 cm/16 G); (15) needle guide for convex
procedure, instruments 1e11 are needed; for percutaneous biopsy procedVolume XXX 
 Issue XXX 
 2025cm/18 G); (2) needle guide for endocavitary probe; (3) sterile gel; (4)
d specimen container; (8) basin, tongs and swabs for disinfection; (9)
ce; (12) needle and syringe for application of local anesthetic; (13) local
be (optional); (16) wound covering. For transvaginal/transrectal biopsy
, instruments 3 and 7e16 are needed.should be trained in gynecological oncology sonography as well as
ultrasound-guided core-needle biopsy and related safety issues, and
should undertake quality assurance and control measures routinely.
The choice of approach to guide the needle’s path, caliber of the needle
and penetration depth are dependent on the specific purpose and the
safety of the procedure. The necessary instruments for core-needle
biopsy are shown in Figure 4. The steps for performing ultrasound-
guided biopsy are described in Table 6 and Videoclips S1eS3. The
characteristics and an illustration of different approaches are presented
in Table S5 and Figures S7 and S8 in Appendix S1.
Statement 23: Before the procedure, the indication should be
verified and the biopsy deemed to be clinically relevant.

 Level of evidence: 3b

 Grade of statement: Chttps://doi.org/10.1016/j.ijgc.2025.101732 10
Table 6 Roadmap for performing ultrasound-guided core-needle biopsy (using automated device)
Step 1: Patient preparation
Ensure calm, comfortable environment and patient dignity.
Review indications for the procedure, multidisciplinary team recommendations and location for planned biopsy.
Obtain medical history, check for allergies and identify risk factors for potential complications.
Explain procedure, risks and benefits to the patient and obtain informed consent. Ask for and address any fears or worries.
Assess risk of bleeding (see Table 4).
Seek specialist advice on withholding anticoagulant/antiplatelet treatment as necessary (see Table 5).
Offer use of oral analgesics such as 1 g paracetamol or oral non-steroidal anti-inflammatory drug, or analgesia suppository (TV/TR/TC
procedure) if desired by the patient.
Administer prophylactic antibiotics if indicated (e.g. in case of passage of the needle through the rectal wall into the peritoneal cavity,
immunocompromised patient, risk of infective endocarditis).
Step 2: Selection of biopsy site and approach
Place patient in lithotomy (TV/TR/TC procedure) or supine (percutaneous) position and cover with a drape.
Perform an ultrasound examination to assess the feasibility of biopsy, identify target lesion, plan the access route to the target lesion and
identify organs at risk of injury.
Use Doppler to identify viable tumor tissue, assess tumor vascularization and identify adjacent vascular structures.
Set up needle guidance line for TV and TR biopsies. Use of needle guide is optional for percutaneous biopsies.
Measure the penetration depth (distance from closest to farthest edge of the tumor to cover the tumor’s full thickness in the planned direction
of biopsy) and set biopsy device accordingly.
Step 3: Infection prevention and instrument preparation
Prior to use, clean and disinfect the ultrasound probes and machine.
Wash hands and perform antisepsis.
Prepare necessary instruments on instrument trolley (Figure 4).
Don sterile gloves.
Apply sterile gel to the transducer and enclose with a disposable transducer cover.
Apply local anesthetic gel to the tip of the covered ultrasound probe (for TV/TR procedure).
Affix needle guide to ultrasound probe (optional for percutaneous approach)
Attach biopsy needle to biopsy device and remove the spacer.
Charge device by pulling the lever and adjust penetration depth accordingly.
Test the firing of the device when in ‘FIRE’ mode then switch to ‘SAFE’ mode.
Step 4: Performing the procedure (Videoclips S1eS3)
Monitor patient comfort throughout the procedure.
Disinfect the vagina or skin (TV and percutaneous procedures, respectively).
A rectal cleansing enema is optional (TR procedure).
Apply local anesthetic as indicated.
Percutaneous procedure: Under ultrasound guidance, administer local anesthetic injection to skin and abdominal wall in direction of the
intended biopsy path up to the target tissue. The skin incision may be extended with a larger bore needle or scalpel for easier entry of the core
needle if required.
TV/TR procedure: Insert the probe using a finger to guard the mucosal surface from the needle guide. Administration of local anesthetic along
the needle trajectory using a long needle placed within the needle guide for anesthetic injection is optional.
TC procedure: A paracervical block can be used.
Hold the probe with one hand and introduce the needle with the needle guide with the other hand. For freehand percutaneous technique, insert
needle along the longitudinal axis of the probe below the ultrasound beam.
Visualize needle tip continuously with ultrasound.
Align needle guidance line (if set up) with the lesion and insert needle to the nearest edge of the viable part of the lesion.
Switch the device to ‘FIRE’ mode and activate the trigger.
Place the specimen in formalin.
Repeat the procedure to obtain three biopsy cores. Between biopsy passes, the ultrasound probe should ideally be left in place, especially if
the probe is inserted in the vagina or rectum.
After each sampling, an assistant helps to move the specimen to a formalin-filled container using either a needle stylet or a normal saline flush.
Ultrasound should be used to detect any signs of internal bleeding.
Percutaneous procedure: Apply pressure at the biopsy site for a few minutes and then cover with a sterile dressing.
TV procedure: Apply puncture site pressure using a gauze swab in the vagina for 1e5 min after the puncture to stop vaginal bleeding if
necessary.
Step 5: Postprocedural requirements
Give the patient time to sit up and dress, and assess her condition.
Inform the patient how and when the results of biopsy will be communicated, and provide written information about signs of potential
complications and emergency contacts. Inform the patient of the use of postprocedural oral analgesia, if required.
In uncomplicated low-risk procedures, no postprocedural monitoring is required.
Label specimen container with patient identifiers.
Fill pathology request form with relevant information:
(continued on next page)
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Fischerova D., et al. IJGC
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Table 6 (continued )
(im
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Fischerova D., et al. IJGC
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 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 24: An ultrasound examination should be performed
to select the safest path to the target lesion and subsequent
approach.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 25: Core-needle biopsy in gynecology does not
require specific preparation such as fasting, or use of laxatives or
antiflatulent medication.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 89% (nZ 16); no, 0% (nZ 0); abstain, 11% (nZ 2)
Statement 26: The preparation should include providing the
patient with procedure-related information, obtaining informed
consent and identifying relevant medical history.

 Level of evidence: 3b

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 27: Bleeding risk assessment should be performed
according to the procedure-related and patient-related risks of
bleeding.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 28: Antibiotic prophylaxis is not recommended
routinely, as the risk of infectious complications is low (< 1%).
$ Patient identifiers
$ Clinical data, radiological data and patient history
$ Details of requesting doctor
$ Biopsy site, type of specimen and fixative used
$ Clinical impression and differential diagnosis
$ Previous histopathological findings (if any)
$ Specific requests to the pathologist according to clinical need
Attach pathology request form to specimen container.
This table was formulated using both data from the literature and by consensus of theHowever, it should be considered on an individual basis, such as for
the transrectal approach, if the needle passes through the rectal
wall into the peritoneal cavity.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 29: Maximum attention should be paid to minimize
patient discomfort, pain and anxiety throughout the procedure.
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 Level of evidence: 2b

 Grade of statement: B

 Consensus: yes, 100% (nZ 18); no, 0% (nZ 0); abstain, 0% (nZ 0)
Statement 30: Basic disinfection procedures are sufficient.
It is important to perform hand antisepsis. Clean handling of
sterile instruments (needles) is recommended. All instruments
should be laid out on a sterile trolley. The disinfected ultra-
sound probe should be covered with a sterile, disposable
protective cover.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 89% (nZ 16); no, 0% (nZ 0); abstain, 11% (nZ 2)
Statement 31: The biopsy device, type of single-use disposable
needles, needle gauge, needle length and penetration depth should
be based on the planned biopsy route.

 Level of evidence: 3b

 Grade of statement: B

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 32: The puncture site should be cleansed with an
antiseptic solution for transvaginal and percutaneous approaches.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 33: Local anesthetic reduces discomfort caused by
larger needle size and should be administered for all percutaneous
biopsies. It can be administered optionally for transvaginal, trans-
cervical and transrectal approaches.

 Level of evidence: 2b
munohistochemistry, molecular analysis or other processing)
y authors.108e113 TC, transcervical; TR, transrectal; TV, transvaginal.
 Grade of statement: B

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 34: While performing the biopsy, the tip of the
needle must be visible under continuous ultrasound control. If not,
the procedure should be abandoned.

 Level of evidence: 5

 Grade of statement: D

 Consensus: yes, 89% (nZ 16); no, 0% (nZ 0); abstain, 11% (nZ 2)
https://doi.org/10.1016/j.ijgc.2025.101732 12
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TStatement 35: Specimen fixation is critical for proper assess-
ment of the tissue. Core-needle biopsy specimen should be placed
immediately in a formalin fixative solution and sent to the pathology
laboratory. Optimal fixation is essential for immunohistochemical
and molecular analysis. A minimum fixation time of 6 h and a
maximum of 72 h is recommended.

 Level of evidence: 3b

 Grade of statement: B

 Consensus: yes, 67% (nZ 12); no, 0% (nZ 0); abstain, 33% (nZ 6)
Statement 36: Ultrasound should be used at the end of the
procedure to detect any signs of bleeding. Mild internal bleeding
usually resolves spontaneously.

 Level of evidence: 5

 Grade of statement: D

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 37: Following uncomplicated procedures, there is no
need for prolonged monitoring. The patient should be informed
about the symptoms of potential complications and provided with a
written information sheet.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Reporting
Biopsy documentation
A detailed report regarding the procedure must be given to the
patient and to her healthcare provider. The following data
should be included: indication(s) for biopsy, preprocedural ul-
trasound findings, procedure description including biopsy device
used, collection guidance (ultrasound) and approach (trans-
vaginal/transrectal/transcervical/percutaneous), biopsy site,
number of samples, adequacy of the sample, difficulty of the
procedure, patient tolerance, any complications and when the
results are expected to be communicated. Biopsy results may
be available between 48 h and 10 days after delivery of the
sample to the laboratory, depending on the complexity of tests
required. Copies of the report and images or videoclips
recording the position of the needle within the lesion should be
stored for future reference.
Specimen and biopsy data sheet
The request form for pathological examination should contain the pa-
tient’s history and clinical and radiological information in detail,
including clinical diagnosis and differential diagnosis. In some situa-
tions, the biopsy is taken from multiple sites, thus all specimens must
be sent separately, clearly labeled, and documented in the request
form.88 The patient details on the specimen container and request form
must be correct and match. Data on the request form and specimen
containers are checked in the pathology laboratory before handling the
specimen and when reporting. A detailed pathological report will then
be discussed by themultidisciplinary team, taking into consideration all
relevant patient data (Table S6 in Appendix S1).89e94
Statement 38: The request form for pathological examinations
should contain:Volume XXX 
 Issue XXX 
 2025- Patient identifiers, including age, gender and unique ID of the patient,
which can differ among countries.
- All relevant clinical, radiological and patient history data.
- Details of the requesting doctor and contact details in case of
emergency.
- The biopsy site(s), clinical impression and differential diagnosis.
- Previous histopathological findings (if any).
- The type of specimen and type of fixative used.
- The patient details on the request form and specimen container must
be correct and match.

 Level of evidence: 4

 Grade of statement: C

 Consensus: yes, 89% (nZ 16); no, 0% (nZ 0); abstain, 11% (nZ 2)
Statement 39: The pathology report form should contain:
- Identification of the patient.
- Type of specimen and sample description.
- Type of processing (for fine-needle aspiration).
- Evaluation of the sample adequacy.
- Limitations.
- Diagnosis.
- Optional: microscopic description, immunohistochemical/immunocyto-
chemical findings, molecular testing findings, differential diagnosis,
recommendation.

 Level of evidence: 3a

 Grade of statement: B

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ 1)
Statement 40: Analytic turnaround time of 2 days (business
days counted only) after receipt of the sample at the pathology
laboratory is required. If ancillary techniques such as immunohis-
tochemistry are needed, the turnaround time is longer.

 Level of evidence: 3b

 Grade of statement: B

 Consensus: yes, 72% (nZ 13); no, 0% (nZ 0); abstain, 28% (nZ 5)
Training and quality assurance
To maintain high quality and safety of image-guided biopsies,
competent operators who are skilled in invasive diagnostic tech-
niques and anatomy are required. This is crucial when accessing
deep lesions in the female pelvis, which can be challenging due to
the proximity of the major vessels, urinary bladder, ureters and
bowel. The operator should possess a high-level understanding of
both the theoretical and practical aspects of the imaging modality
used for guidance and the interventional procedures. Developing
the necessary skills and techniques involves a steep learning curve,
and sufficient volume is required to maintain operator confidence.95
Similarly, competent pathologists and cytopathologists are essential
for accurate reading of the biopsy samples.
For gynecologists/radiologists
Learning interventional ultrasound should always be built upon the
knowledge of diagnostic (non-interventional) ultrasound imaging of
the area of interest.96 It is advisable that core-needle biopsy is
performed by examiners who already have an intermediate (Euro-
pean Federation of Societies for Ultrasound in Medicine and Biology
level II) or advanced (level III) level of competence in gynecological
ultrasound imaging.97 For radiologists, training in interventional
radiology is recommended.15 Studies indicate that the learninghttps://doi.org/10.1016/j.ijgc.2025.101732 13

 Level of evidence: 4

 Grade of statement: B
Fischerova D., et al. IJGC
SOCIETY
STATEM
ENTcurve can be shortened by adding simulator-based or phantom-
based training to clinical practice.98 Web-based teaching resources
are also available.99 Clinical training should begin under supervision
by an experienced operator and with ‘simple’ core-needle biopsy or
fine-needle aspiration procedures. When performing percutaneous
biopsy, commercially available sonographic guides attached to the
transabdominal probe may provide more confidence regarding the
needle position inside the body and are recommended for less
experienced operators.100,101 There is a lack of large studies
assessing the impact of examiner experience and training on
complication rate when performing pelvic core-needle biopsy. We
recommend carrying out at least 20 core-needle biopsy proced-
ures, supervised by an experienced operator, before embarking on
the procedure unsupervised.
After achieving competence, operators are recommended to
continue to perform these procedures on a regular basis. It is
therefore reasonable to adopt the same recommended minimal
number, i.e. 20 core-needle biopsies annually per operator.
There should be regular audits of sampling accuracy for ma-
lignant tissue and the rate of inadequate specimens submitted
within each practice providing biopsy services.95,102 Similarly, re-
views of complications and patient experience should be con-
ducted, to identify and address the need for improvement and
additional training of staff. Preprocedural provision of patient in-
formation, periprocedural psychosocial support, provision of a
comfortable environment and postprocedural monitoring of patient-
reported complications may improve patients’ experience.
For pathologists
Pathologists reporting biopsy samples should have completed their
postgraduate training in pathology, according to the national au-
thority rules.103,104
Training competencies that pathologists should demonstrate
include: (1) the ability to produce clear, concise, comprehensive
and timely written reports for surgical pathology and cytopathology;
(2) the ability to incorporate the diagnostic, prognostic or predictive
implications of molecular pathology tests into an integrated pa-
thology report; (3) promotion of health informatics to improve the
quality of patient care and optimize patient safety; (4) participation
in quality control, quality assurance and quality improvement ini-
tiatives; (5) utilization of genetic testing resources effectively to
balance costs with potential utility of result; (6) alerting of the
treating physician when inheritable conditions are identified (e.g.
genetic disease that may affect the patient’s family members).
To maintain competence in pathological reporting, pathologists
or cytopathologists should be part of a gynecological oncology
multidisciplinary team in a high-volume center. As part of quality
assurance, participation in accredited programs for all aspects of
tissue diagnostics, for both clinical and non-clinical laboratories and
organizations, is recommended.105e107
Statement 41: Training for operators:
- Training to at least intermediate (level II) or advanced (level III) level in
gynecological ultrasound imaging is essential before commencing
training in interventional ultrasound.
- Training in ultrasound-guided biopsy using phantoms and/or computer
simulation improves skills and is useful prior to clinical training.
- Targeted training using directly supervised procedures is essential to
reduce the risk of complications and increase sample adequacy.Volume XXX 
 Issue XXX 
 2025
 Consensus: yes, 89% (nZ 16); no, 0% (nZ 0); abstain, 11% (nZ 2)
Statement 42: Maintaining competence for operators:
- Maintain competency by completing or supervising a minimum of 20
core-needle biopsy procedures annually.
- Seek support from a more experienced operator when difficulties are
anticipated or encountered.

 Level of evidence: 3b

 Grade of statement: C

 Consensus: yes, 83% (nZ 15); no, 0% (nZ 0); abstain, 17% (nZ 3)
Statement 43: Audit for operators:
- Regular audits should be undertaken within each practice providing
biopsy services to ensure sampling adequacy and diagnostic yield, and
to record complications and patient experience.

 Level of evidence: 3b

 Grade of statement: C

 Consensus: yes, 89% (nZ 16); no, 0% (nZ 0); abstain, 11% (nZ 2)
Statement 44: Training for pathologists/cytopathologists:
- Biopsies should be read by a pathologist or cytopathologist who has
completed his/her postgraduate training in pathology/cytopathology.
The rules are defined by national authorities and can differ among
countries.

 Level of evidence: 5

 Grade of statement: C

 Consensus: yes, 89% (n Z 16); no, 0% (n Z 0); abstain, 11%
(n Z 2)
Statement 45: Maintaining competence for pathologists/
cytopathologists:
- Ultrasound-guided biopsies should be performed in a specialized center
with access to a pathologist or cytopathologist with experience in gy-
necological oncology as part of a multidisciplinary team.

 Level of evidence: 5

 Grade of statement: C

 Consensus: yes, 94% (nZ 17); no, 0% (nZ 0); abstain, 6% (nZ
1)
Statement 46: Audit for pathologists/cytopathologists:
- Accreditation of laboratories should be in accordance with national or
international standards (such as ISO15189). The rules of accreditation
are defined by national authorities in each country and can differ.

 Level of evidence: 5

 Grade of statement: C

 Consensus: yes, 89% (nZ 16); no, 0% (nZ 0); abstain, 11% (nZ 2)
CONCLUSION
Core-needle biopsy under ultrasound guidance is an emerging,
minimally invasive outpatient procedure. It allows collection of- The needle-guiding system should be used by trainees for all
approaches.
- At least 20 directly supervised core-needle biopsies using a needle
guide should be performed before starting unsupervised work.https://doi.org/10.1016/j.ijgc.2025.101732 14
Fischerova D., et al. IJGC
SO
CI
ET
Y
ST
AT
EM
EN
Thigh-quality specimens for histopathological diagnosis, immuno-
histochemical analysis and molecular testing, enabling the timely
commencement of appropriate treatment within a specialized
cancer center. Performing core-needle biopsy and interpreting its
results requires appropriate expertise and should be conducted
within a multidisciplinary team. Under these circumstances, it is
simple, quick, effective and safe. To ensure patient-centered
care, standard operational procedures, including measures to
minimize patient anxiety, pain and risk, are essential. This
Consensus Statement aims to facilitate the implementation of
this technique in gynecological oncology practice and improve
patient outcomes.
Author Affiliations
1Department of Gynecology, Obstetrics and Neonatology, First Faculty of Medicine,
Charles University and General University Hospital in Prague, Prague, Czech Republic
2Institut Bergonie, Bordeaux, France
3University of Navarra, Pamplona, Spain
4Department of Pathology, First Faculty of Medicine, Charles University and General
University Hospital in Prague, Prague, Czech Republic
5Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset,
Stockholm, Sweden
6iNOVA4Health, NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM,
Universidade NOVA de Lisboa, Lisbon, Portugal
7Instituto Portugues de Oncologia de Lisboa Francisco Gentil, Lisbon, Portugal
8Unità Operativa di Chirurgia dei Organi Genitali Esterni Femminili, Divisione di
Ginecologia Oncologica, Dipartimento Scienze della Salute della Donna, del Bambino
e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome,
Italy
9Gemelli Women Health Center for Digital and Personalized Medicine, Dipartimento
Scienze della Vita e Sanità Pubblica, Università Cattolica del Sacro Cuore, Rome, Italy
10Mohn Medical Imaging and Visualization Centre (MMIV), Department of Radiology,
Haukeland University Hospital, Bergen, Norway
11EGA Institute for Women’s Health, University College London, London, UK
12Department of Gynaecology, National Institute of Oncology, Budapest, Hungary
13Gynecologic Oncology Service, Nairi Medical Center, National Institute of Health,
Yerevan, Armenia
14Department of Gynecological Oncology, Pomeranian Hospitals (Szpitale
Pomorskie), Gdynia, Poland
15Clinic of Surgical Oncology, Faculty of Health Sciences with the Institute of
Maritime and Tropical Medicine, Medical University of Gdansk, Gdansk, Poland
16Department of Development and Regeneration, KU Leuven, Leuven, Belgium
17Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven,
Belgium
18Department of Gynaecological Oncology, KK Women’s and Children’s Hospital,
Singapore
19Academic Unit of Obstetrics and Gynecology, Hospital Polyclinic San Martino and
University of Genoa, Genoa, Italy
20Hospital QuirónSalud, Málaga, Spain
21Section for Radiology, Department of Clinical Medicine, University of Bergen,
Bergen, Norway
22Doctoral School of Clinical Medicine, University of Szeged, Szeged, Hungary
Disclosure P.D. is a member of advisory boards for AstraZeneca, Merck, MSD,
GlaxoSmithKline, Amgen, Janssen-Cilag and Roche, and has received grants for
travelling from AstraZeneca. A.F. has participated as a member of the speakers’
bureau for GlaxoSmithKline. T.V. is a member of advisory boards for Bayer,
Boehringer Ingelheim, BMS/Pfizer, Daiichi Sankyo, Sanofi Aventis, and Leo
Pharma. D.F., F.P., J.L.A., E.E., F.F., G.G., I.S.H., D.J., R.K., D.L., F.M., A.S., M.S.,
S.T., Z.Y.N. and U.S. report no conflicts of interest.
Acknowledgments This article has been simultaneously co-published in
Ultrasound in Obstetrics & Gynecology and International Journal of Gynecological
Cancer. The articles are identical except for minor stylistic and spelling
differences in keeping with each journal’s style. Any citation can be used when
citing this article. We thank Lucia Zanchi (MD, University of Pavia, Pavia, Italy),Volume XXX 
 Issue XXX 
 2025Natacha Sousa (MD, Hospital de Braga, Braga, Portugal) and Kim Hulscher
(ENGAGE Co-Chair, European Network of Gynaecological Cancer Advocacy Groups)
for intellectual contribution and suggestions during proofreading, Adam Preisler
(Polygoniq Studio, Prague, Czech Republic) for providing the illustrations and
Tomas Herrmann (Institute of Scientific Information, First Faculty of Medicine,
Charles University Prague, Prague, Czech Republic) for videoclip editing. We thank
ISUOG and ESGO for their support, especially Kamila Macku and Lenka Trestrova,
who provided invaluable logistical and administrative support throughout the
process. We wish also to express sincere gratitude to Maciej Malecki (University
Hospital Leuven, Leuven, Belgium) for providing technical support during the
voting process. All costs relating to the development process were covered by
ISUOG and ESGO. There was no external funding for the development process or
manuscript production.
Supplemental material Supplementary data to this article can be found online at
https://doi.org/10.1016/j.ijgc.2025.101732.
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