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NOT YET RECRUITING
NCT07343869

Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection

Sponsor: Société Française d'Endoscopie Digestive

View on ClinicalTrials.gov

Summary

In France in 2018, there were an estimated 2,074 new cases of esophageal adenocarcinoma and 3,224 cases of squamous cell carcinoma. The estimated deaths from esophageal cancer were 3,725, with a standardized 5-year net survival rate of 20% for cases diagnosed between 2010 and 2015, mainly due to late diagnosis. Surgery was historically the standard treatment for localized disease but carries significant morbidity. Over the past decade, endoscopic treatments, particularly endoscopic submucosal dissection (ESD), have become the reference approach for superficial esophageal cancers. After endoscopic resection, histological analysis allows classification of recurrence risk into very low, low, and high categories. Predicting lymph node or distant recurrence is complex, depending on factors such as depth of wall infiltration, lymphovascular invasion, and tumor differentiation. The frequent combination of unfavorable histological features may have led to an overestimation of lymph node involvement risk in T1b cancers. ESD is widely performed in France, with over 1,600 procedures reported in 2023 for esophageal and gastric lesions, demonstrating the feasibility of a large observational study. This multicenter French cohort will evaluate technical, oncological, and organizational outcomes of esophageal ESD, including overall survival, recurrence-free survival, and management of residual Barrett's esophagus. It will also identify predictive factors for treatment success, recurrence, and complications, providing real-world evidence to guide patient management.

Official title: Prospective Multicenter Cohort on Esophageal Submucosal Dissection: Evaluation of Technical, Oncological, and Organizational Outcomes in Real-Life Practice

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

750

Start Date

2026-02-01

Completion Date

2036-02-01

Last Updated

2026-01-15

Healthy Volunteers

No

Locations (1)

Jules Verne Clinic

Nantes, France