PelviSound L-Real-time intraoperative sonographic assessment of pelvic sentinel lymph nodes using a drop-in probe in endometrial and cervical cancer during minimally invasive surgery: A single-center pilot feasibility study in 20 patients.

objectiveSentinel lymph node biopsy (SLNB) is considered an essential step in the surgical management of endometrial and cervical cancers as it has led to a reduction in the need for full pelvic lymphadenectomy. This proof-of-concept study aimed to evaluate the feasibility and diagnostic performance of intraoperative sonographic assessment of sentinel lymph nodes (SLNs) during laparoscopic and robotic surgeries for endometrial and cervical cancers.

methodsThis was a prospective, single-center, non-interventional diagnostic feasibility study conducted between October 2023 and July 2024 at the University Women's Hospital, Tübingen, Germany, and registered at the German Clinical Trials Register (DRKS00032919). A total of 20 patients underwent intraoperative sonographic SLN evaluation using a sterile drop-in ultrasound probe prior to resection. The assessment was based on the Vulvar International Tumor Analysis (VITA) criteria that includes parameters, such as lymph node shape, cortical thickening, vascularization, and echogenicity. Findings were correlated with histopathologic results to determine diagnostic accuracy. To assess the diagnostic accuracy of the sonographic criteria, a receiver operating characteristic (ROC) analysis was conducted, focusing on sensitivity and specificity with respect to lesion dignity classification (benign vs malignant).

resultsAmong the 25 initially prepped patients, 20 successfully underwent intraoperative sonographic SLN evaluation, while five were excluded due to logistical issues or consent withdrawal. A total of 49 SLNs were analyzed, and the analysis included histopathologic confirmation. The sonographic assessment demonstrated perfect sensitivity and specificity of 1.0 as reflected by the area under the ROC curve (AUC = 1.0). No adverse events were reported.

conclusionThe study confirms that intraoperative sonographic evaluation of SLNs in minimally invasive gynecologic oncology surgeries is feasible, safe, and highly accurate. This technique may serve as a valuable adjunct to current SLNB protocols and lead to a potential reduction in the need for extensive lymphadenectomy while concurrently maintaining diagnostic reliability. Further research using larger cohorts is warranted to validate these findings and assess broader clinical applicability.