Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociété Française d'Endoscopie Digestive

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patient refusal after reading the information sheet

Patient under legal protection (guardianship, curatorship, court-ordered protection)

Inability to inform the patient due to cognitive impairment, language barrier, or medical emergency

Patients previously included for another lesion in the same study

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed