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
This trial does not accept healthy volunteersQualifiers
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 population
Eligible patients include all individuals referred to a participating center for endoscopic resection of an esophageal lesion and treated by submucosal dissection. This is a prospective, multicenter, observational study, conducted on an intention-to-treat basis. All consecutive patients referred for esophageal ESD will be included.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Recurrence-free survival according to adjuvant treatment
Recurrence-free survival will be evaluated in patients after endoscopic submucosal dissection (ESD) of superficial esophageal carcinoma. Patients may receive adjuvant therapy (surgery, chemotherapy, or chemoradiotherapy) at the treating physician's discretion. Recurrence includes local, regional, or metastatic relapse as defined by clinical, endoscopic, and imaging criteria and validated by multidisciplinary team discussion. Recurrence will be monitored throughout the 5-year follow-up period to compare outcomes between patients receiving adjuvant therapy versus surveillance.
Secondary outcomes
R0 resection rate
Proportion of patients with tumor-free lateral and deep margins confirmed by histopathology.
En bloc resection rate
Proportion of lesions resected in a single piece exclusively by ESD.
Curative resection rate
Proportion of R0 resections meeting favorable histological criteria: no lymphovascular invasion, no tumor budding, well-differentiated tumor, submucosal invasion \<200 µm (squamous cell carcinoma) or \<500 µm (adenocarcinoma).
30-day complication rate
Rate of per- or post-procedural bleeding, immediate or delayed perforation, and strictures requiring endoscopic dilation.
Sponsors and contacts
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