Evaluating a New Ultrasound-Guided Biopsy Method for Diagnosing Uterine Smooth Muscle Tumors in Women Undergoing Surgery

What this Trial Is About

Uterine fibroids are benign smooth muscle tumors of the uterus that are part of a broader group including malignant tumors with varying severity. Magnetic resonance imaging MRI is commonly used to differentiate fibroids from malignant tumors, but it has limitations that can lead to inappropriate treatment. This study aims to validate a new minimally invasive biopsy technique called ultrasound-guided transuterine vaginal biopsy BVTE to improve preoperative diagnosis and avoid unnecessary or harmful surgeries for uterine smooth muscle tumors. The procedure involves performing the BVTE under general anesthesia on the day scheduled for myomectomy or hysterectomy. The biopsy targets the center of the tumor via a transuterine route to reduce the risk of spreading cancer cells, taking 4 to 5 samples per tumor with a maximum of three tumors sampled. After the biopsy, patients undergo the planned surgery during the same operation, and all surgical specimens are sent for anatomopathological analysis. Participants will be assessed through anatomopathological comparison of the biopsy samples with the reference surgical specimens throughout the study period of 43 months. Researchers will monitor intraoperative and postoperative complications using the Clavien-Dindo classification. This study evaluates the feasibility, safety, and diagnostic accuracy of the BVTE technique as part of current clinical practice for women requiring surgical treatment for uterine smooth muscle tumors.

Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease