Pre-surgical Tru-Cut biopsy of sonographically atypical myometrial lesions: A prospective pilot study
This study aimed to evaluate the feasibility and safety of Tru-Cut biopsy as a complementary diagnostic tool in the pre-operative evaluation of sonographically atypical myometrial lesions in patients scheduled for uterine surgery. Secondary objectives included determining the diagnostic accuracy, sensitivity, and specificity of Tru-Cut biopsy in pre-operative tumor characterization and patient's perceived peri-procedural pain. In this pilot study, all consecutive patients aged ≥18 years with atypical myometrial lesions based on ultrasonography referred to our institution's Centre of Minimally Invasive Surgery between June 2022 and June 2023 underwent pre-operative trans-vaginal or trans-cervical ultrasound-guided Tru-Cut biopsy, followed by surgical treatment. Samples were considered adequate if histologic tumor typing was possible. Diagnostic accuracy was determined by comparing Tru-Cut biopsy histology with final post-operative histology. Of 39 patients who underwent Tru-Cut biopsy, 27 (69.2%) were diagnosed with conventional leiomyoma, 9 (23.1%) with benign atypical myometrial lesion, 1 (2.6%) with smooth muscle tumor of uncertain malignant potential, and 2 (5.1%) had inadequate samples. The median pain score immediately post-Tru-Cut biopsy was 4 (interquartile range; 3-5), with no pain reported 24 hours later. Complications occurred in 2 patients (5.2%): 1 required hospitalization for collapse and another underwent laparoscopic intervention for abdominal bleeding. Among the 37 adequate samples, Tru-Cut biopsy findings were concordant with final histology in 34 cases (diagnostic accuracy 91.9%; 95% confidence interval [CI] 78.7 to 97.2). Tru-Cut biopsy sensitivity and specificity were 88.9% (95% CI 56.5 to 98.0) and 92.9% (95% CI 77.4 to 98.0), respectively. This pilot study indicates that Tru-Cut biopsy is a feasible, safe, and accurate method for pre-operative assessment of atypical myometrial lesions, providing histologically adequate samples for diagnostic evaluation. Larger studies are warranted to validate these results.