NCT07306195

Comparison Between High and Low Level Para-aortic Lymphadenectomy in High and Intermediate Risk Endometrial Carcinoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Ahmed Aouf · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Endometrial cancer (EC) is the most frequent gynecological malignancy in developed countries and ranks second in incidence worldwide after cervical cancer, accounting for nearly 10% of cancers in women . With the adoption of comprehensive surgical staging, the identification of extra-uterine disease has become central to treatment and prognosis. Lymph node involvement, particularly para-aortic nodal metastasis, represents one of the most important independent prognostic factors . The uterus has a complex lymphatic drainage, with pathways leading to the obturator, iliac, caval, aortic, parametrial, and presacral basins. Direct channels from the uterine fundus to the para-aortic nodes via the infundibulopelvic ligament explain metastatic spread to the para-aortic region, although isolated para-aortic involvement in the absence of pelvic nodal disease is uncommon. Recognition of these drainage patterns underscores the importance of evaluating both pelvic and para-aortic lymph nodes in high- and intermediate-risk patients . Several studies suggest that systematic lymphadenectomy, including the para-aortic region, improves survival by enhancing staging accuracy and guiding adjuvant therapy. Combined pelvic and para-aortic lymphadenectomy (PALD) has been associated with increased 5-year overall survival, improved disease-free survival, reduced recurrence, and decreased need for adjuvant radiotherapy . However, the optimal extent of para-aortic dissection remains debated. Para-aortic nodes are subdivided relative to the inferior mesenteric artery (IMA) into inframesenteric (low-level) and supramesenteric (high-level). While high-level PALD may improve detection of occult metastases, it increases surgical complexity and morbidity . Risk stratification of EC guides the extent of staging. High-risk disease includes non-endometrioid histologies, grade 3 endometrioid carcinoma with \>50% myometrial invasion, and advanced local spread. Intermediate-risk disease encompasses grade 1-2 tumors with deep or larger-volume myometrial invasion. Patients in these categories have a significant risk of nodal involvement (up to 16%), warranting para-aortic evaluation . The present study aims to compare high versus low PALD in intermediate- and high-risk EC with emphasis on nodal yield, histopathological characteristics, staging, and oncological outcomes.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
PROCEDURE	high level para-aortic lymphadenectomy	All women underwent total hysterectomy with bilateral salpingo-oophorectomy combined with systematic pelvic lymphadenectomy and high-level PALD was done .The small bowel and mesentery were carefully mobilized to expose the aorta and inferior vena cava (IVC) above the IMA, with dissection proceeding cranially to the left renal vein. The anatomical landmarks were consistently identified to ensure complete lymphatic clearance within the defined field. Excised lymph nodes were counted intraoperatively and verified by histopathology.
PROCEDURE	low level para-aortic lymphadenectomy	All women underwent total hysterectomy with bilateral salpingo-oophorectomy combined with systematic pelvic lymphadenectomy and high-level PALD was done .The small bowel and mesentery were carefully mobilized to expose the aorta and inferior vena cava (IVC) , the dissection was restricted to the infra-mesenteric region between the aortic bifurcation and the IMA. The anatomical landmarks were consistently identified to ensure complete lymphatic clearance within the defined field. Excised lymph nodes were counted intraoperatively and verified by histopathology.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-04-30
• Completion: 2025-05-01
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: Egypt