NCT07306195Befejeződött
Comparison Between High and Low Level Para-aortic Lymphadenectomy in High and Intermediate Risk Endometrial Carcinoma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 29.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 150 (tényleges)
- Első benyújtás
- 2025. dec. 2.
- Kezdés
- 2022. okt. 1.
- Elsődleges befejezés
- 2025. ápr. 30.
- Fő szponzor
- Ahmed Aouf
- Betegségek
- Gyermekkori daganatok, Méhtestrák
- NCT-szám
- NCT07306195
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 150
- 2022. okt. 1. és az elsődleges befejezés (2025. ápr. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patients were excluded if they had general contraindications to surgery, morbid obesity that precluded safe operative access, or if they declined to participate.
Kiket keres a vizsgálat
- 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.
Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Kafr-Elsheikh University Hospital | Kafr ash Shaykh | Egyiptom | Ismeretlen állapot |
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