NCT07343869Not yet recruiting
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Prospective Multicenter Cohort on Esophageal Submucosal Dissection: Evaluation of Technical, Oncological, and Organizational Outcomes in Real-Life Practice
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 750 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Dec 2031
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07343869
What you commit to
- Study type: Observational
- Planned participants: 750
- From 1 Feb 2026 to the primary completion date, 1 Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously included for another lesion in the same study
Other illness
- Inability to inform the patient due to cognitive impairment, language barrier, or medical emergency
Other
- Patient refusal after reading the information sheet
- Patient under legal protection (guardianship, curatorship, court-ordered protection)
- Pregnant or breastfeeding women.
- Patient deprived of liberty.
- Patient currently enrolled in another clinical trial.
Who the study is looking for
- Adults (≥ 18 years old)
- Patients referred for endoscopic resection of an esophageal lesion and treated by submucosal dissection
- Patients managed in one of the participating centers
- Patient who has received oral and written information about the study and has not objected to participation
- Patients covered by a social security or health insurance scheme.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jules Verne Clinic Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.