Biopsia Transvaginal para Tumor Pelvico

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Gynecologic Oncology 161 (2021) 845–851

Contents lists available at ScienceDirect

Gynecologic Oncology

journal homepage: www.elsevier.com/locate/ygyno

Safety and efficiency of performing transvaginal ultrasound-guided


tru-cut biopsy for pelvic masses
H. Verschuere a, W. Froyman a,b, T. Van den Bosch a,b, M. Van Hoefs a, J. Kaijser c, D. Van Schoubroeck a,b,
A.S. Van Rompuy d, I. Vergote a,e, D. Timmerman a,b,⁎
a
Department of Obstetrics and Gynecology, University Hospitals Leuven, 3000 Leuven, Belgium
b
Department of Development and Regeneration, KU Leuven, 3000 Leuven, Belgium
c
Department of Obstetrics and Gynecology, Ikazia Hospital, 3083 AN Rotterdam, the Netherlands
d
Department of Pathology, University Hospitals Leuven, 3000 Leuven, Belgium
e
Department of Oncology, Leuven Cancer Institute, KU Leuven, 3000 Leuven, Belgium

H I G H L I G H T S

• Transvaginal tru-cut biopsy of pelvic masses is a safe procedure to perform with high adequacy.
• Multiple biopsies are recommended to optimize the tissue yield for histological diagnosis.
• The main indication for tru-cut biopsy is suspected disseminated disease or recurrence of malignant conditions.

a r t i c l e i n f o a b s t r a c t

Article history: Objective. To assess the safety, adequacy and accuracy of transvaginal ultrasound-guided tru-cut biopsy of
Received 27 December 2020 pelvic masses.
Accepted 24 March 2021 Methods. We performed a retrospective analysis of consecutive women who underwent transvaginal
Available online 12 April 2021
ultrasound-guided tru-cut biopsies between June 2014 and October 2018 at the Department of Obstetrics and
Gynecology of the University Hospitals Leuven. Main indications for tru-cut biopsy were tissue collection for
Keywords:
Tru-cut biopsy
diagnosis of pelvic tumors in cases of suspected disseminated disease or recurrence, or tissue banking for re-
Transvaginal ultrasound search purposes. Data about adverse events occurring within 2 weeks of the procedure (including bleeding,
Ultrasound-guided invasive procedures blood transfusion, hospital admission, urgent surgery, pelvic infection or death) were extracted from electronic
Pelvic mass medical records. Tissue samples were recorded as adequate if tumor identification and immunohistochemistry
Metastatic disease were possible. Accuracy was defined in patients who underwent surgery as the agreement between histology
Gynecological tumor after tru-cut biopsy and final histology.
Results. 176 tru-cut biopsies were performed in 155 patients. Procedure related events were limited to mod-
erate blood loss (<50 ml) without the need for treatment in 4.5%. There were no major complications. Biopsies
were deemed adequate for histological evaluation in 84.3% of biopsies performed for diagnostic purposes and in
71.4% of research cases in whom a single tissue cylinder was available for diagnosis. When at least two cylinders
were available, diagnostic adequacy increased to >95%. Comparing final histology, the diagnostic accuracy of the
tru-cut biopsies was 97.2%.
Conclusion. Transvaginal tru-cut biopsy for diagnosis of pelvic masses is a safe procedure. To allow an ade-
quate and accurate diagnosis, we advise taking at least 2 core biopsies.
© 2021 Elsevier Inc. All rights reserved.

1. Introduction
⁎ Corresponding author at: University Hospitals Leuven, Department of Obstetrics and
Gynaecology, Herestraat 49, 3000 Leuven, Belgium. Ovarian cancer is known to be the 4th most lethal tumor in women
E-mail addresses: [email protected] (W. Froyman), and has the highest mortality rate of all gynecological malignancies. In
[email protected] (T. Van den Bosch), [email protected] (J. Kaijser),
[email protected] (D. Van Schoubroeck),
most women, the disease is not diagnosed until in advanced stage [1].
[email protected] (A.S. Van Rompuy), [email protected] Moreover, ovaries are a common site for distant metastases. In 4% of
(I. Vergote), [email protected] (D. Timmerman). ovarian masses, a metastasis from a tumor with another primary origin

https://doi.org/10.1016/j.ygyno.2021.03.026
0090-8258/© 2021 Elsevier Inc. All rights reserved.

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H. Verschuere, W. Froyman, T. Van den Bosch et al. Gynecologic Oncology 161 (2021) 845–851

can be found [2]. Most ovarian metastases arise from breast or gastroen- center is situated in close proximity to an outpatient treatment
terological cancers [3,4]. room equipped to perform small procedures, such as suturing and
In primary ovarian cancer, patients may benefit from either primary electrocauterization, if complications should occur. Prior to biopsy, as-
debulking surgery or neoadjuvant therapy, depending on tumor staging sessment of the procedure safety was done by ultrasound scanning. Pa-
and patients' comorbidities [5]. In recurrent disease, treatment may in- tients were excluded if they did not discontinue anticoagulation therapy
clude surgery, radiotherapy or systemic therapy, depending on primary or if the lesion was not safely accessible due to vaginal stenosis, bowel or
tumor histology, extent of the recurrence, previous treatment and bladder interposition, or close proximity of large blood vessels. Color
disease-free interval [6–8]. In pelvic masses with ultrasound features Doppler was used as guidance for identification of a viable portion of
suggesting metastatic disease, management will be guided by the origin tumor tissue avoiding large blood vessels and necrotic tissue. Biopsies
of the primary tumor [9,10]. Therefore, histological diagnosis is impor- were performed under ultrasound guidance, using a 25 cm 18-gauge
tant to select the optimal treatment strategy. needle automatic biopsy system (MAX-CORE Bard® REF MC1825)
Tissue sampling by diagnostic laparoscopy or explorative laparot- with a penetration depth of 22 mm. Scanning machines used were GE
omy requires general anesthesia and hospital admission, leading to Voluson E6, E8, E10 or Samsung WS80. Dakin® (Sodium Hypochlorite
higher costs and to potential surgical morbidity. Moreover, in advanced 5%) was used to disinfect the vagina. Sterile Endosgel® (1.57 g/
stage ovarian cancer, diagnostic laparoscopy is associated with port-site 50.5 mg containing Sodium Lactate and Chlorhexidine Digluconate) or
metastases, in up to 17–49% [11,12,13]. Instillagel® (0.23 g/0.0057 g gel containing local Lidocaine Hydrochlo-
Minimally invasive procedures for diagnosis include fine-needle as- ride Chlorhexidine Digluconate) was used to optimize ultrasound
piration and tru-cut biopsy. wave transmission. The transvaginal ultrasound probe was covered
Fine-needle aspiration allows for cytological evaluation only [14], with a latex-free cover, the needle guide was mounted to the probe,
whereas tru-cut biopsy allows for histological examination including and was subsequently covered with a second latex-free probe cover
immunohistochemistry [15,16]. filled with sterile gel (Fig. 1). The number of tissue cylinders taken
A tru-cut biopsy can be performed under the guidance of different ranged from 1 to 4. Every biopsy contained an 18 mm cylinder. No addi-
imaging modalities including ultrasound, Computed Tomography (CT) tional local anesthetic or sedation was given prior to or during to the
and Magnetic Resonance Imaging (MRI). However, percutaneous CT- procedure.
guided biopsies of deep pelvic masses are challenging because vital As part of the routine care, all patients undergoing tru-cut biopsy
structures often obstruct the needle pathway [17]. The same hurdle were scheduled for a follow-up visit two weeks after the procedure, in
may be expected with MRI-guided percutaneous biopsy. order to discuss the biopsy results and schedule further treatment. Pa-
Previous studies have investigated the use of ultrasound-guided bi- tients were also advised to contact the gynecology department or the
opsies for the assessment of abdominal and pelvic masses showing a emergency room if they felt unwell, had pyrexia, abdominal pain or
high diagnostic adequacy and minimal complication rate [4,16,18–26]. heavy vaginal bleeding. Reports of complications were retrieved from
Ultrasound guided biopsies can be performed by percutaneous the electronic patient charts of subsequent consultations at any depart-
transabdominal or transvaginal approach. ment, urgent consultations at the emergency department and subse-
The primary aim of this study was to evaluate the safety of quent hospital admissions.
performing transvaginal ultrasound-guided tru-cut biopsy in pelvic Safety was reported as the percentage of patients developing one of
masses. Secondary aims were evaluation of the adequacy and accuracy the following complications within 14 days after the procedure: pres-
of the biopsies performed. ence of post-procedural vaginal bleeding, need for vaginal tamponade,
blood transfusion, hospital admission, urgent surgery, pelvic infection
2. Methods or sepsis, and death.
Samples were defined as adequate if the tissue yield allowed for
The study was a retrospective analysis including consecutive pa- histological analysis and immunohistochemistry. We also assessed ade-
tients undergoing tru-cut biopsy between June 2014 until October quacy adjusted to Body Mass Index (BMI), more specifically in patients
2018 at the Department of Obstetrics and Gynecology of the University with normal weight or overweight (BMI < 30 kg/m2) versus obesity
Hospitals Leuven. Data were collected by reviewing electronic patient (BMI > 30 kg/m2). Accuracy was assessed, in patient who underwent
records, including ultrasound reports, pathology reports and admissions surgery, as the agreement between histology after tru-cut biopsy and
in other departments of our hospital. We obtained approval from the the final histology. In case of benign results, and in absence of subse-
Ethics Committee of the University Hospitals Leuven (S62136). quent surgery, biopsies were considered accurate if patients have been
Indications for biopsies were divided into 5 groups: (A) suspected at least 12 months in follow up without suspicion or observation of a
primary gynecological disseminated tumor, (B) suspected recurrence malignant condition based on clinical findings or imaging.
(cases with a history of a gynecological tumor), (C) suspected secondary
metastasis (cases with a history of a non-gynecological tumor), 3. Results
(D) diagnosis of a solitary lesion (no history of malignancy), (E) research
purposes (known persistent inoperable tumor). Biopsies taken in group 3.1. Patient characteristics
A to D were performed for diagnosis while in group E, biopsies were per-
formed as requested to comply with the eligibility criteria for participa- A total of 176 transvaginal tru-cut biopsy procedures were per-
tion in translational research trials. formed on 155 patients: 136 patients underwent the procedure once,
Because of the readily availability in our center, patients are first 17 patients had a second biopsy due to inadequate previous sampling
assessed for transvaginal ultrasound-guided biopsy. This procedure or for a new indication, and two patients underwent a third biopsy.
was first introduced in our department in 2010. In case the lesions are The mean age at first tru-cut biopsy was 64 years (range 24–93; SD
not accessible for a safe transvaginal procedure, patients are referred 14.27) and the majority of patients (89.0%) were postmenopausal. Men-
to the radiology department for transabdominal ultrasound-guided bi- opausal state was uncertain in 1 case. The mean BMI was 25.87 kg/m2
opsy of CT-guided biopsy for histological diagnosis. The latter popula- (range 15.9–45.7; SD 5.45), 29 patients (20.1%) were obese (BMI > 30
tion is not the scope of this study. kg/m2), and in 11 patients (7.1%) BMI data were lacking. Seventy pa-
All biopsies were performed by operators trained in gynecological tients (45.2%) had a history of hysterectomy and 13 women (8.4%)
ultrasound and tru-cut biopsies (DT, JK, WF). The procedures were car- had previous pelvic radiotherapy (Table 1A).
ried out in an outpatient setting, in a regular ultrasound examination When patients were classified according to the indication for biopsy,
room at the gynecology ultrasound center. However, the ultrasound 56 were classified in group A (suspected primary gynecological

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H. Verschuere, W. Froyman, T. Van den Bosch et al. Gynecologic Oncology 161 (2021) 845–851

Fig. 1. (A): transvaginal probe with latex-free cover (*), needle holder (‡), automatic biopsy system (§); (B) needle holder mounted on transvaginal probe, transvaginal probe covered with
second latex-free cover, Instillagel® used for transmission ultrasound waves; (C) automatic biopsy system (MAX-CORE Bard® REF MC1825) inserted in needle holder.

disseminated tumor); 16 in group B (suspected recurrence: cases with and 68 in group E (research purposes in patients with known persistent
history of a gynecological tumor); 20 in group C (suspected secondary inoperable tumor) (Table 2).
metastasis: cases with history of non-gynecological tumor); 16 in Group D (diagnosis of a solitary lesion) consisted of 14 biopsies per-
group D (diagnosis of a solitary lesion without history of malignancy) formed for confirmation of a presumed benign lesion on ultrasound
(ovarian fibromas, uterine fibroids, abscess and endometriosis). Two bi-
opsies were performed for histological evaluation of a presumed malig-
Table 1 nant lesion: 1 patient with a history of hysterectomy and bilateral
(A) Patient characteristics at first tru-cut biopsy (B) Biopsy characteristics in all biopsies.
salpingo-oophorectomy for severe endometriosis underwent a tru-cut
A: Patient characteristics at first tru-cut biopsy (n = 155) biopsy for a suspicious lesion fixed on the vaginal vault; 1 patient had
Parameter Mean range SD a suspicious para-urethral lesion. Both tru-cut biopsies were performed
without risk of intra-abdominal spilling. In 22 patients (12.5%),
Age (years) 64 24–93 14.27
BMI (kg/m2) 25.87 15.9–45.7 5.45
anticoagulation medication was stopped before the procedure. In 19
Parameter n (%) cases (10.8%) the procedure was performed while on anti-platelets
History of hysterectomy 70 (45.2%) therapy. In 142 procedures (80.7%) biopsies were performed on a
History of pelvic radiotherapy 13 (8.4%) solid mass, in 8 cases (4.5%) on a unilocular-solid lesion and in 26 pro-
Menopausal state
cedures (14.8%) on a multilocular-solid mass. The site of biopsy was
Premenopausal 16 (10.3%)
Postmenopausal 138 (89.0%) the ovary in 70 cases (39.8%), the uterus in 11 (6.3%), the cervix in 10
Unknown 1 (0.6%) (5.7%), the vagina in 4 (2.3%) and the pelvic peritoneum in 74 cases
Diagnosisa (42.0%). In 7 procedures (4.0%) the biopsy location was elsewhere:
Ovarian cancer 92 (59.4%) pararectal, bladder wall, or parametrium (Table 1B).
Endometrial/uterine cancer 11 (7.1%)
Cervical/vaginal cancer 9 (5.8%)
Based on histological and/or clinical findings, 92 patients (59.4%)
Non-gynecological malignancy 20 (12.9%) were diagnosed with ovarian cancer, 11 patients (7.1%) had endome-
Benign 22 (14.2%) trial/uterine cancer, 9 (5.8%) had cervical/vaginal cancer and in 20 pa-
Malignant process unknown origin 1 (0.6%) tients (12.9%) the diagnosis of a non-gynecological malignancy was
B: Procedure related characteristics (n = 176) made. Twenty-two patients (14.2%) had a benign lesion and in 1 patient
Parameter n (%) the origin of malignant process was unknown (0.6%) (Table 1A).
Discontinuation anticoagulation 22 (12.5%) Vaginal, cervical and endometrial cancer can be easily diagnosed
Concurrent anti-platelets therapy 19 (10.8%)
with targeted biopsies under direct visualization of the vaginal wall,
Lesion type (as described on ultrasound)
Solid 142 (80.7%)
Unilocular – solid 8 (4.5%)
Multilocular – solid 26 (14.8%) Table 2
Site of biopsy Indication for tru-cut biopsy (n = 176).
Ovary 70 (39.8%)
Indication for tru-cut biopsy n (%)
Uterus 11 (6.3%)
Cervix 10 (5.7%) Group A: suspected primary disseminated gynecological tumor 56 (31.8%)
Vagina 4 (2.3%) Group B: suspected recurrence (gynecological tumor) 16 (9.1%)
Peritoneum 74 (42.0%) Group C: suspected metastasis (non-gynecological tumor) 20 (11.4%)
Other 7 (4.0%) Group D: diagnosis of a solitary lesion (no history of malignancy) 16 (9.1%)
a Group F: scientific research (known persistent malignancy) 68 (38.6%)
Diagnosis based on histology, if histology not available based on clinical and radio-
Total 176 (100%)
logical findings.

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H. Verschuere, W. Froyman, T. Van den Bosch et al. Gynecologic Oncology 161 (2021) 845–851

cervix or with endometrial biopsies. However, a small group of patients Table 3


with this diagnosis also had an additional ultrasound-guided tru-cut bi- Recorded events after procedure (n = 176).

opsy, mainly in the case of recurrent disease or in order to exclude me- Parameter n (%) n (%) related to procedure
tastasis from another primary tumor. After primary histological Post-procedure blood loss
diagnosis of stage III or IV endometrial cancer based on endometrial bi- None/mild 137 (77.8%) 137 (77.8%)
opsy, the procedure was performed on pelvic metastatic lesions to ex- Moderate 8 (4.5%) 8 (4.5%)
clude concomitant ovarian cancer in 5 cases. In 1 case a primary Severe 0 (0%) 0 (0%)
Unknown 31 (17.6%) 31 (17.6%)
vaginal cancer was confirmed with tru-cut biopsy of a vaginal vault le-
Need for hemostatic pressure 6 (3.4%) 6 (3.4%)
sion in a patient with a surgical history of a hysterectomy with negative Blood transfusion 5 (2.8%) 0 (0%)
targeted biopsies. One patient diagnosed with stage IV cervical cancer Hospital admission 18 (10.2%) 0 (0%)
underwent a tru-cut biopsy of a pelvic mass because of a concomitant Urgent surgery 0 (0%) 0 (0%)
diagnosis of breast cancer to exclude pelvic metastasis from breast can- Sepsis/PID 2 (1.1%) 0 (0%)
Death 3 (1.7%) 0 (0%)
cer. Four patients diagnosed with recurrent cervical cancer (2 had
previous radiochemotherapy and 2 had a previous surgery with hyster-
ectomy) had an ultrasound-guided tru-cut biopsy because there was no
visible lesion at speculum examination or prior negative targeted biopsy
of the lesion. Tru-cut biopsy for research purposes was performed on The remaining 68 biopsies were performed for research purposes. In
pelvic metastatic lesions in 3 patients with recurrent cervical cancer 19 of these there was no histology report available. The tissue yield of 35
and 1 patient with recurrent endometrial cancer. One had previous ra- of the remaining 49 biopsies allowed for histological examination,
diochemotherapy, 2 previous hysterectomy and 1 patient had both. resulting into an adequacy of 71.4% (Fig. 2). Importantly, in this group
a maximum of one single tissue cylinder was used for histological diag-
nosis, as the remaining tumor tissue was sent to an external laboratory
3.2. Safety for research purposes. In 3 cases only a single cylinder biopsy was taken
and divided into smaller pieces. Only a small piece was used for histo-
In 137 cases (77.8%) no or minor blood loss was recorded after tru- logical examination and the remaining tissue was sent to an external
cut biopsy (i.e. ultrasound cover with some blood stains) and in 8 laboratory. None of these three samples were adequate for diagnosis.
cases (4.5%) blood loss was described as moderate. There were no While the total number of single cylinder biopsies performed de-
cases of severe blood loss ≥50 mL. In 31 procedures (17.6%) blood loss creased from 25.0% in 2014 to 8.6% in 2018, the overall adequacy in-
had not been reported. In 6 cases (3.4%) vaginal tamponade was per- creased from 75.0% to 88.0%, respectively (fig.
formed for hemostasis. All these events were directly procedure related, 3B). No differences in adequacy could be found between BMI < 30
however these bleeding episodes were minor and self-limiting within kg/m2 (79.7%) and BMI > 30 kg/m2 (80.7%).
the outpatient setting, without need for further action. Furthermore, We found no difference between the adequacy of biopsies in solid le-
we investigated all adverse events occurring within 2 weeks after the sions (79.3%) and cystic-solid lesions (81.8%). Adequacy according to lo-
procedure and found that 5 patients received a blood transfusion cation of tru-cut biopsy was 76.4% for ovarian lesions, 90% for cervical
(2.8%): 3 patients had chronic anemia and required blood transfusions lesions, 100% for vaginal lesions, 81.8% for peritoneal lesions and 100%
prior to starting chemotherapy; 1 patient with chronic anemia received for other locations. There was insufficient data about the dimensions
blood prior to talc pleurodesis; 1 patient had a transfusion because of of the lesion to measure adequacy according to the lesion size.
postoperative anemia after hysterectomy. 17 patients underwent the procedure twice and 2 patients three
Sepsis occurred in 2 patients (1.1%). One patient had a large pelvic times resulting in 21 repeated biopsies on 19 patients. Six procedures
mass and secondary bilateral hydroureteronephrosis. She developed were performed after a previous failed tru-cut biopsy with inadequate
urosepsis after bilateral double J stents insertions and a left nephrostomy. results, leading to a correct histological diagnosis after a second ade-
The other patient, who had a stage IV high grade ovarian cancer, devel- quate biopsy was taken in all 6 cases. In 2 cases the procedure was re-
oped ischemic bowel necrosis with perforation leading to a large abscess peated after a benign histological diagnosis because of possible
with peritonitis. She died 9 days after the procedure, but this was not discordance with the ultrasound diagnosis, but leading to a repeated be-
deemed procedure related. Two other patients died within 14 days nign histology result in both cases. All repeated biopsies were per-
after the tru-cut biopsy (total deceased patients 1.7%): one of them formed within 1 to 4 weeks after the previous biopsy.
chose palliative care and died, the other was diagnosed with a high- In 13 cases the second biopsy was performed for a new indication. In
grade serous adenocarcinoma from tubo-ovarian origin with a large pel- all these cases biopsy was requested to comply with eligibility for par-
vic mass, retrocrural, retroperitoneal and mediastinal lymph nodes and ticipation in translational research trials.
large supraclavicular lymph nodes up to 8 cm. The cause of death of
the latter was not reported but it was assumed to be due to extensive
3.4. Accuracy
and rapid tumor progression. Hospital admission was necessary in 18
cases (10.2%). Nobody underwent urgent surgery within 2 weeks after
Out of 108 diagnostic biopsies performed in 100 patients (8 patients
the biopsy procedure. Most importantly, none of the adverse events
had repeat biopsies) 45 patients (45.0%) eventually underwent surgery.
were reported to be directly related to the tru-cut biopsy, but rather to
In 37 of these cases, tissue samples from tru-cut biopsy were adequate
the course of the disease and the patients' poor general condition
for histological diagnosis prior to surgery. One patient with a high-
(Table 3).
grade ovarian cancer had a complete response after neoadjuvant che-
motherapy and tumor tissue after surgical treatment could not be
3.3. Adequacy found. In one case, the histological diagnosis on tru-cut biopsy was en-
dometrial cancer, while after surgical treatment the final diagnosis
The overall adequacy was 80.2%. Out of 108 biopsies performed was a high grade serous ovarian cancer. This means that in 35 out of
for diagnostic purposes, 91 were deemed adequate (84.3%). We found 36 (97.2%) adequate tru-cut biopsies, the histology result was con-
an adequacy of 75% (15/20) if one cylinder had been taken, 94.4% firmed at final diagnosis.
(34/36) if 2 cylinders were taken and 100% (7/7) if 3 or 4 cylinders In 7 other cases, tru-cut biopsy was inadequate. Histology diagnosis
had been taken. In 45 diagnostic procedures the number of cylinder bi- was only made after surgery with targeted biopsies or complete re-
opsies was unknown (Fig. 3A). moval of the lesions. In one case, targeted biopsies of the lesions during

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Fig. 2. Adequacy biopsies.

diagnostic laparoscopy were still unable to provide histological diagno-


sis due to necrosis.
Out of the 100 patients undergoing diagnostic biopsy, 78 patients
had a diagnosis of malignancy. After transvaginal tru-cut biopsy, 21 pa-
tients were confirmed to have ovarian cancer and could start neoadju-
vant chemotherapy without prior surgical staging. In another 5
patients tissue sampling at diagnostic laparoscopy could not confirm
the diagnosis of malignancy at histology. In 4 out of these, the final diag-
nosis of ovarian cancer was made at subsequent tru-cut biopsy, and
neoadjuvant chemotherapy could be initiated. In the fifth patient, the
tru-cut biopsy could not provide a final diagnosis either. Only three pa-
tients with ovarian malignancy underwent a diagnostic laparoscopy
after tru-cut biopsy (2 patients because of negative tru-cut biopsy, 1 pa-
tient for surgical staging but prior confirmed histology by tru-cut bi-
opsy). These three patients proceeded to neoadjuvant chemotherapy.
Four patients with suspected ovarian cancer and negative tru-cut biop-
sies died prior to surgical staging and histological diagnosis.
Three patients with a diagnosis of stage III or IV endometrial cancer
started neoadjuvant chemotherapy after histological confirmation by
tru-cut biopsy of intraperitoneal lesions.
A total of 16 patients with a gynecological malignancy received pri-
mary surgical treatment after tru-cut biopsy. In 3 cases preoperative
tru-cut biopsy was inadequate for histological diagnosis. 6 patients
with other gynecological malignancies (non-ovarian, non-endometrial)
received chemotherapy and/or radiotherapy after histological confirma-
tion by tru-cut biopsy.
In 5 cases, a primary diagnosis of a non-gynecological malignancy was
made by tru-cut biopsy, avoiding diagnostic laparoscopy or laparotomy.
Four patients underwent primary surgical treatment after diagnosis of a
non-gynecological malignancy. In 10 cases a diagnosis of recurrence of
a non-gynecological tumor was possible without surgery for histological
confirmation. One patient with negative tru-cut biopsy was diagnosed
Fig. 3. (A) Adequacy of diagnostic biopsies according to number of cylinder biopsies taken
in procedure (B) Number of cylinder biopsies taken between 2014 and 2018 with
with a recurrence of a non-gynecological malignancy after laparoscopic
concurring yearly adequacy. unilateral salpingo-oophorectomy.

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4. Discussion our study was 80.2%, which seems substantially lower than in previous
studies. One explanation is that 38.6% of procedures were performed for
In our study we found that transvaginal ultrasound guided tru-cut research purposes. Focusing on patients with diagnostic biopsies, we
biopsies are safe to perform with good adequacy. No major procedure observed an increased adequacy of 84.3%. A second explanation is that
related complications were observed. All reported adverse events this study reflects our center's experience at the beginning of the imple-
(blood transfusion, sepsis, death, hospital admission) within 2 weeks mentation of this procedure. Indeed, comparing adequacy of biopsies
of the procedure were attributed to the course of the disease and the over the years, an increase was observed from 75% in 2014 to 88% in
poor general condition of those patients. We have also shown that ade- 2018. This could be attributed to the operators' increasing experience
quacy of tissue sampling improved with the number of cylinders taken, with the procedure. Furthermore, the proportion of single cylinder
without increasing the risk of major procedure-related complications. tru-cut biopsies decreased over the years, since we had already experi-
Our study is one of the largest (n = 176) studies assessing safety and enced that adequacy after single cylinder biopsy was lower.
adequacy in transvaginal ultrasound guided tru-cut biopsies. Only Lin We also investigated the influence of obesity on the adequacy of
et al. had a larger number of transvaginal biopsies (n = 200) [25]. The transvaginal tru-cut biopsies, but BMI did not seem to affect adequacy.
limitations of our study were its retrospective design as well as the Tru-cut biopsy performed on a patient with a BMI of 45.7 kg/m2 still
number of missing or incomplete data. We tried to avoid selection gave an adequate sample. As opposed to the transabdominal approach,
bias by including consecutive cases retrieved by queries performed on the close proximity of the transvaginal probe to the lesions enables tru-
pathology reports and ultrasound report forms in the electronic medical cut biopsies even in extreme obesity. This observation confirms previ-
records. These patient records also allowed us to keep track of all pa- ous results that BMI does not influence adequacy using the transvaginal
tients during the first two weeks after the biopsy procedure to detect approach [21].
any complications. By performing transvaginal tru-cut biopsy, 24 patients (of in total 78
Nevertheless, findings such as blood loss or the number of tissue cyl- with a diagnostic biopsy showing malignancy) with an advanced stage
inders taken, were not consistently reported, neither the detailed ultra- endometrial (n = 3) or ovarian cancer (n = 21) could start neoadjuvant
sound descriptions of the target lesion. There were no standardized chemotherapy without need for diagnostic laparoscopy or laparotomy.
assessments of patients' procedure-related experience available. How- In some circumstances, once histology is known, surgical staging can
ever, from our clinical experience, the overall subjective impression is be replaced by imaging. In our center, whole body diffusion weighted
that patients tolerate the procedure well with minimal discomfort, if Magnetic Resonance Imaging (MRI) is used for staging and prediction
the operator pays attention to gentle probe manipulation using a suffi- of incomplete resection in ovarian cancer, as this has been shown to
cient amount of gel. A second limitation could be the fact that we also be superior to Computed Tomography (CT) [27].
included patients undergoing biopsies for research purposes. In these In our study, another 15 patients were diagnosed with a non-
cases, part of the tissue was sent to an external laboratory, leaving less gynecological malignancy after tru-cut biopsy (5 with primary diagno-
tissue available for histological examination. Therefore, we have re- sis and 10 with recurrence) and could start systemic treatment. In
ported on adequacy for patients with diagnostic biopsies and those these cases, ultrasound-guided biopsy replaced diagnostic surgical pro-
with research biopsies separately. However, we decided not to exclude cedures (laparoscopy or laparotomy) prior to starting systemic therapy,
these patients for the safety analysis, as we wanted to report on consec- thereby avoiding potential surgical morbidity, higher costs and possible
utive patients, including this patient population with a worse general delay in treatment.
condition due to recurrent or progressive disease. Finally, it is important to keep in mind that tru-cut biopsy should not
Previous studies have investigated the safety of tru-cut biopsies, al- be performed in all patients presenting with a pelvic mass. Patient selec-
though a limited number used the transvaginal approach. In the study tion is pivotal, as it is known that cyst rupture in women with a malig-
by Fischerova et al. (n = 86) no complications were reported in the nant ovarian tumor confined to the ovaries could lead to upstaging of
transvaginal group, compared to the transabdominal approach where the disease, eventually resulting into a worse prognosis [28]. Therefore,
a single complication caused a bleeding with hemoperitoneum and re- in our center, the procedure is restricted to diagnosis of pelvic tumors in
quired mini-laparotomy [16]. Zikan et al. (n = 195) reported two case of suspected disseminated disease (primary ovarian or secondary
major complications of bleeding at the biopsy site requiring surgery, from another primary origin) or recurrence. In patients with solitary le-
but the approach of tru-cut biopsy was not mentioned in these cases sions and without a history of malignancy, tru-cut biopsy should be con-
[21]. Epstein et al. (n = 143) reported two admissions for inpatient sidered very carefully. Examples in our series were histological
care related to biopsy: one patient had an abdominal wall hematoma confirmation of presumed benign lesions on ultrasound (e.g. uterine fi-
after transabdominal percutaneous biopsy, and another patient had a broids). Only very rarely, tru-cut biopsy can be done on suspicious soli-
suspected pelvic infection after tru-cut biopsy with transvaginal ap- tary lesions, for instance if located on the vaginal vault or vaginal wall,
proach [4]. Four studies (n > 50) focusing on the transvaginal approach without risk of causing intra-abdominal spilling.
only, reported no major complications [22,23,25,26]. Other studies re- In conclusion, our study shows that transvaginal ultrasound guided
ported no complications, although sample size was small (n < 25) tru-cut biopsies are safe to perform with good adequacy. Our data also
[18–20]. We believe that a benefit of the transvaginal access for biopsy suggest that multiple biopsies should be taken to optimize the amount
of pelvic lesions is the precise guidance of the needle, the lower occur- of tissue for histological examination. We strongly recommend reserv-
rence of bowel interposition and the possibility to apply local pressure ing this procedure for a well indicated population, including patients
in case of bleeding, as compared to a transabdominal approach. with suspected disseminated disease or recurrence of malignant
Multiple studies have investigated the adequacy of transvaginal tru- conditions.
cut biopsy ranging from. The procedure's safety, adequacy and accuracy as well as patient ex-
88.4–100% [4,16,18,19,21–23,25,26]. Only Faulkner et al. had a lower perience needs to be validated in large prospective study.
adequacy of 7/12 biopsies [20]. However, most studies had rather small
sample sizes or included the transabdominal approach. They also did
not assess the role of the number of cylinder biopsies. In three studies
the number of cylinder biopsies, 1 to 3 tissue cylinders, was recorded, Declaration of Competing Interest
but no further assessment on the minimum number of cylinder biopsies
to reach a high adequacy was reported [4,21,25]. Overall adequacy in All authors have no conflicts of interest to report for this manuscript.

850

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2021. Para uso personal exclusivamente. No se permiten otros usos sin autorización. Copyright ©2021. Elsevier Inc. Todos los derechos reservados.
H. Verschuere, W. Froyman, T. Van den Bosch et al. Gynecologic Oncology 161 (2021) 845–851

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851

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