Comparison Between High and Low Level Para-aortic Lymphadenectomy in High and Intermediate Risk Endometrial Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- descriptive operative outcome
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The patient were randomized into two groups , group A and group B. The patients and the investigators were blinded from patient selection by giving the patient a sealed envelope . The patient allocation was done by computer software to achieve the randomization. The investigators were blinded from patient selection by handing them a sealed envelope and outcome assessors also were blinded from patient details at the follow up sessions
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The inclusion criteria consisted of women diagnosed with either intermediate- or high-risk EC, based on established pathological and radiological criteria. •Intermediate-risk patients included those with grade 1/2 endometrioid carcinoma with <50% myometrial invasion and tumor size >2 cm, grade 1/2 with 50-66% invasion, or grade 3 with <50% invasion.
- •High-risk cases were defined as non-endometrioid histology (serous or clear cell), grade 1 or 2 endometrioid carcinoma with more than 66% invasion, grade 3 with more than 50% invasion, or the presence of adnexal metastasis.
Exclusion Criteria
- •Patients were excluded if they had general contraindications to surgery, morbid obesity that precluded safe operative access, or if they declined to participate.
Outcomes
Primary Outcomes
descriptive operative outcome
Time Frame: 1 week
The primary surgical outcome is para-aortic nodal yield how to measure paraaortic LN Yeild : surgical removal and pathological analysis, focusing on the number of nodes harvested (total yield) and the number of positive nodes (involved yield) relative to total nodes.
Secondary Outcomes
- survival outcome(1 year)
Investigators
Ahmed Aouf
dr-sponsor
Kafrelsheikh University