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To assess the safety, adequacy and accuracy of transvaginal ultrasound-guided tru-cut biopsy of pelvic masses.We performed a retrospective analysis of consecutive women who underwent transvaginal 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 diagnosis of pelvic tumors in cases of suspected disseminated disease or recurrence, or tissue banking for research purposes. Data about adverse events occurring within 2 weeks of the procedure (including bleeding, blood transfusion, hospital admission, urgent surgery, pelvic infection or death) were extracted from electronic medical records. Tissue samples were recorded as adequate if tumor identification and immunohistochemistry were possible. Accuracy was defined in patients who underwent surgery as the agreement between histology after tru-cut biopsy and final histology.176 tru-cut biopsies were performed in 155 patients. Procedure related events were limited to moderate 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 to95%. Comparing final histology, the diagnostic accuracy of the tru-cut biopsies was 97.2%.Transvaginal tru-cut biopsy for diagnosis of pelvic masses is a safe procedure. To allow an adequate and accurate diagnosis, we advise taking at least 2 core biopsies.

Objective To estimate the diagnostic value of tumor and immune related proteins in the discrimination between benign and malignant adnexal masses, and between different subgroups of tumors. Methods In this exploratory diagnostic study, 254 patients with an adnexal mass scheduled for surgery were consecutively enrolled at the University Hospitals Leuven (128 benign, 42 borderline, 22 stage I, 55 stage II-IV, and 7 secondary metastatic tumors). The quantification of 33 serum proteins was done preoperatively, using multiplex high throughput immunoassays (Luminex) and electrochemiluminescence immuno-assay (ECLIA). We calculated univariable areas under the Receiver Operating Characteristic Curves (AUCs). To discriminate malignant from benign tumors, multivariable ridge logistic regression with backward elimination was performed, using bootstrapping to validate the resulting AUCs. Results CA125 had the highest univariable AUC to discriminate malignant from benign tumors (0.85, 95% confidence interval 0.79-0.89). Combining CA125 with CA72.4 and HE4 increased the AUC to 0.87. For benign vs borderline tumors, CA125 had the highest univariable AUC (0.74). For borderline vs stage I malignancy, no proteins were promising. For stage I vs II-IV malignancy, CA125, HE4, CA72.4, CA15.3 and LAP had univariable AUCs ≥0.80. Conclusions The results confirm the dominant role of CA125 for identifying malignancy, and suggest that other markers (HE4, CA72.4, CA15.3 and LAP) may help to distinguish between stage I and stage II-IV malignancies. However, further research is needed, also to investigate the added value over clinical and ultrasound predictors of malignancy, focusing on the differentiation between subtypes of malignancy.