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

NCT ID: NCT07306195

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-05-01

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.

Conditions

Endometrial Cancer

Keywords

Endometrial Cancer; hystrectomy; para-aortic lymphadenectomy; high level para-aortic lymphadenectomy; low level para-aortic lymphadenectomy; survival outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

group B low

underwent low-level PALD, in which lymph node dissection was confined to the infra-mesenteric region, extending from the aortic bifurcation to just below the IMA.

Group Type: ACTIVE_COMPARATOR

low level para-aortic lymphadenectomy

Intervention Type: PROCEDURE

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.

group A high

underwent high-level PALD, where lymphatic dissection was extended above the IMA up to the left renal vein.

Group Type: ACTIVE_COMPARATOR

high level para-aortic lymphadenectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ahmed Aouf

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Aouf

dr-sponsor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kafr Elsheikh University Hospital

Kafr ash Shaykh, , Egypt

Countries

Egypt

References

Somashekhar, S. P. et al. Prospective Non-randomized Control Trial on Role of Systematic High Para-Aortic Lymphadenectomy in Endometrial Cancer: Indian Study. Indian J Gynecol Oncolog 19, 6 (2021). 2. Jung, U. S., Choi, J. S., Bae, J., Lee, W. M. & Eom, J. M. Systemic Laparoscopic Para-Aortic Lymphadenectomy to the Left Renal Vein. JSLS 23, e2018.00110 (2019). 3. El-Agwany, A. S. & Meleis, M. H. Value and best way for detection of Sentinel lymph node in early stage endometrial cancer: Selective lymphadenectomy algorithm. European Journal of Obstetrics & Gynecology and Reproductive Biology 225, 35-39 (2018). 4. Petousis, S. et al. Combined pelvic and para-aortic is superior to only pelvic lymphadenectomy in intermediate and high-risk endometrial cancer: a systematic review and meta-analysis. Arch Gynecol Obstet 302, 249-263 (2020). 5. AlHilli, M. M. & Mariani, A. The role of para-aortic lymphadenectomy in endometrial cancer. Int J Clin Oncol 18, 193-199 (2013). 6. Zammarrelli, W. A. et al. Risk Stratification of Stage I Grade 3 Endometrioid Endometrial Carcinoma in the Era of Molecular Classification. JCO Precis Oncol e2200194 (2022) doi:10.1200/PO.22.00194. 7. Yang, Y., Wu, S. F. & Bao, W. Molecular subtypes of endometrial cancer: Implications for adjuvant treatment strategies. International Journal of Gynecology & Obstetrics 164, 436-459 (2024). 8. Thammineedi, S. R., Iyer, R. R., Naren, B. & Patnaik, S. C. Lymphadenectomy in Endometrial Cancers-A Review. Indian J Gynecol Oncolog 19, 77 (2021). 9. AlHilli, M. M. et al. Preoperative biopsy and intraoperative tumor diameter predict lymph node dissemination in endometrial cancer. Gynecologic Oncology 128, 294-299 (2013). 10. Hashmi, A. A. et al. Morphological Spectrum and Pathological Parameters of Type 2 Endometrial Carcinoma: A Comparison With Type 1 Endometrial Cancers. Cureus 12, (2020). 11. Song, S.-H. et al. Clinicopathologic Characteristics and Prognostic Factors of Stage I and II Endometrial cancer of the uter

Reference Type: RESULT

Other Identifiers

KFSIRB200-762

Identifier Type: -

Identifier Source: org_study_id