Diagnostic performance of ultrasound-guided biopsy for detecting recurrent or persistent cervical cancer after chemoradiotherapy: a prospective, single-center study
This study aimed to compare the feasibility, diagnostic accuracy, and sample adequacy of trans-vaginal ultrasound-guided biopsy versus per-vagina biopsy for detecting persistent or recurrent pelvic disease after chemoradiotherapy for locally advanced cervical cancer. Procedure-related pain was also evaluated. This prospective, single-center diagnostic study conducted at Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome, Italy) from November 2019 to September 2024 included consecutive patients with clinical or radiologic suspicion of persistent or recurrent cervical cancer after chemoradiotherapy. Patients undergoing trans-vaginal ultrasound-guided biopsy and per-vagina biopsy (index tests) were analyzed. Histology from pelvic exenteration or follow-up imaging when surgery was not performed served as the reference standard. Accuracy, sensitivity, and specificity were calculated for each index test and compared using the McNemar test. Feasibility was defined as the rate of successfully performed biopsies and adequacy as the proportion of samples yielding a conclusive histologic diagnosis. Fifty-three patients were included. A total of 44 of 53 patients (83.0%) underwent pelvic exenteration, whereas 9 of 53 (17.0%) underwent imaging follow-up. Ultrasound-guided biopsy was feasible in 52 of 53 cases (98.1%) compared with 40 of 53 cases (75.5%) for per-vagina biopsy. All samples obtained from both techniques were adequate. Ultrasound-guided biopsy showed a sensitivity of 0.84, specificity of 1.00, and accuracy of 0.87. Per-vagina biopsy showed a sensitivity of 0.55, specificity of 0.86, and accuracy of 0.60. Among 39 paired feasible cases, specificity did not differ significantly between the 2 techniques (p = .27); however, ultrasound-guided biopsy showed significantly higher sensitivity and accuracy (p = .022 and p = .021, respectively). Ultrasound-guided biopsy appeared to be a feasible method for histologic confirmation in suspected persistent or recurrent cervical cancer after chemoradiotherapy. It demonstrated superior diagnostic accuracy over per-vagina biopsy and holds potential for routine clinical application. Successful integration into clinical practice requires appropriate clinician training and access to specialized equipment.