In a transvaginal tru-cut biopsy, guided by ultrasound, a needle is inserted through the vaginal wall into a pelvic lesion and a few pieces of tissue are obtained for examination.
This clinical trial is organized to evaluate the safety and efficacy of transvaginal tru-cut biopsy in a large group of patients with tumors in the small pelvis.
Lesion safely accessible (no visceral or vessel interposition; in the case of a transvaginal approach no vaginal stenosis (severe atrophy - virgo - vaginismus); within reach of biopsy needle)
Solid component present (purely cystic lesions excluded)
Suspicious primary disseminated gynecologic tumor (tumor itself or metastasis) Patients with a presumable new diagnosis of a disseminated pelvic tumor where histological confirmation of disease is necessary before the possibility to start a specific oncologic treatment and
Are invalid candidates for primary (radical) surgery due to comorbidities or poor overall general wellbeing
None
All consecutive patients (\> 18 years) undergoing a tru-cut biopsy at the collaborating centers for a pelvic mass.
Cohort
Prospective
Ultrasound guided tru-cut biopsy
Procedure/SurgeryTru-cut biopsies can collect tissue specimens via a needle of 18G A tru-cut biopsy can be performed under the guidance of different imaging modalities including ultrasound
Safety
Defined as absence of procedure-related complications. Procedure related complications will be graded by Clavien-Dindo classification.
Tissue yield
Defined as sufficient amount of tissue for histological analysis. This will be a binary variable based on the pathology report.
Factor 1 affecting safety and tissue yield
A number of biopsies per target lesion,
Factor 2 affecting safety and tissue yield
The length of the needle shot (15 vs 22 mm).
Factor 3 affecting safety and tissue yield
The thickness of needle (16-18 Gauge).
Factor 4 affecting safety and tissue yield
The target lesion histotype - categorical variable defined by the tumour type.
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Universitaire Ziekenhuizen KU Leuven
Lead sponsor
UZ Leuven, Leuven, Belgium
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Charles University, Czech Republic
Collaborator
Karolinska Institutet and Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.
Collaborator
