Ultrasonography-Guided Core Needle Biopsy in the Diagnostic Pathway of Pelvic Tumors

Accurate histologic diagnosis of pelvic tumors is essential for guiding appropriate management but often requires diagnostic surgery, which is associated with morbidity and treatment delays. Ultrasonography-guided core needle biopsy offers a minimally invasive alternative that may reduce surgical risks while providing reliable diagnostic information.

To assess the safety and diagnostic adequacy of ultrasonography-guided core needle biopsy in patients with pelvic tumors and to evaluate diagnostic accuracy, patient experience, and pain levels associated with the procedure.

This prospective, multicenter cohort study was performed from May 26, 2021, to December 31, 2024, at 4 high-volume gynecologic oncology centers (Leuven, Belgium; Rome, Italy; Prague, Czech Republic; and Stockholm, Sweden), with follow-up at 6 weeks after the procedure. Consecutive patients aged 18 years or older with a pelvic tumor undergoing ultrasonography-guided core needle biopsy for diagnostic purposes or inclusion in academic trials were included, and follow-up data were available for all participants.

Ultrasonography-guided core needle biopsy performed via transvaginal, transrectal, or percutaneous approaches according to lesion location and clinical indication.

The primary outcomes were safety, as assessed by procedure-related complication rates within 6 weeks, and diagnostic adequacy of biopsy specimens. Secondary outcomes included diagnostic accuracy compared with subsequent surgical histology when available, patient-reported pain measured using a numeric rating scale (0-100), and overall patient experience assessed within 72 hours post procedure. Descriptive statistical and multivariable regression analyses were performed.

Among 461 patients prospectively enrolled in the study, biopsies were performed on 463 lesions (transvaginal: 422 patients; median [IQR] age, 64 [53-73] years; transrectal: 11 patients; median [IQR] age, 78 [59-80] years; percutaneous: 30 patients; median [IQR] age, 58 [51-71] years). Procedure-related complications occurred in 60 patients (13.0%), all of which were minor; no patients required surgery or blood transfusion due to complications. Biopsy specimens were diagnostically adequate in 95.7% (95% CI, 93.4%-97.4%) of cases. In 166 cases with available subsequent surgical histology, diagnostic accuracy was 97.6% (95% CI, 93.9%-99.3%). Patient experience was favorable, with 378 of 402 patients (94.0%) rating their experience in the upper half of the scale. The median pain score was 20 (IQR, 10-50).

This cohort study of patients undergoing ultrasonography-guided core needle biopsy of pelvic lesions found the procedure to be safe, diagnostically adequate, and well-tolerated. These findings support the procedure's broader implementation in selected patients to reduce the need for diagnostic surgery and associated morbidity.