Phase III Study Comparing Sentinel Lymph Node Mapping to Standard Lymph Node Removal During Minimally Invasive Hysterectomy for Stage I Endometrial Cancer Impact on Leg Swelling and Limb Function

What this Trial Is About

Researchers are evaluating two different lymph node assessment methods during minimally invasive hysterectomy for patients with stage I endometrial cancer confined to the uterus. This phase III trial compares sentinel lymph node SLN mapping, which uses a special dye and camera to identify lymph nodes, with the standard lymph node dissection that removes nodes around the uterus. The goal is to assess which method better reduces the risk of swelling in the legs, also known as lymphedema, and to understand potential long-term impacts on limb function and cancer outcomes. Participants are randomly assigned to one of two groups. In the first group, patients receive an injection of indocyanine green ICG dye for SLN mapping and excision if mapping is incomplete, additional lymph nodes may be removed on that side. In the second group, patients also receive ICG dye and undergo SLN mapping but then have additional lymph nodes removed as per standard care. Both groups undergo minimally invasive hysterectomy, imaging as needed, and optional blood sample collection throughout the study. After surgery, participants are followed regularly with visits every three months for one year, and then at 18 and 24 months. Researchers will collect patient-reported symptoms using questionnaires, measure changes in leg circumference, track SLN detection and cancer spread, and monitor complications. The main outcome is the occurrence of leg dysfunction reported by patients from 18 to 39 months after surgery. The study also examines treatment decisions, safety, and cost-effectiveness of the lymph node assessment strategies.

Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer