ESD for the Treatment of Early Barrett's Neoplasia

Study Overview
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Brief Summary
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This study assesses the quality of the resection of early neoplasia arinsing in Barrett's esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection.

Detailed Description
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Endoscopic submucosal dissection ( ESD) demonstrated great efficacy in the treatment of squamous cell carcinoma of the esophagus. Results for the treatment of esophageal adenocarcinoma arising in Barrett's esophagus are conflicting. In this multicenter prospective registry among 7 French centers, all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection will be included in the registry. The primary objective is to assess the quality of the resection by ESD of early Barrett's neoplasia (T1A or T1B sm1 or high grade dysplasia). Secondary endpoints are to assess the combined efficacy of a treatment associating ESD and radiofrequency ablation of the remaining Barrett esophagus, and to assess the durability of the results after 3 years.

Official Title
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Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia

Conditions
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Barrett Esophagus, Esophageal Neoplasm

Intervention / Treatment
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* Procedure: endoscopic submucosal dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Barrett's esophagus at least C0M2 with histological documentation of intestinal metaplasia Visible abnormality of at least 15 mm in size Absence of mediastinal or coeliomesenteric enlarged lymph nodes or muscle layer invasion on pretherapeutic EUS Absence of mediastinal or coeliomesenteric enlarged lymph nodes or metastases on pretherapeutic CT scan Exclusion Criteria: History of esophageal external irradiation History of esophagectomy or gastrectomy gastrectomie ou d'oesophagectomie Esophageal stricture Esophageal varices grade 3 or of any grade with signs of recent bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: endoscopic submucosal dissection|Endoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of histologically complete (R0) resection of esophageal adenocarcinoma or high grade dysplasia | R0 resection rate = horizontal margins free from cancer or high grade dysplasia, and vertical margins free from carcinoma. | 3 months after ESD initial procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of en bloc resection via ESD | presence of a single fragment of tissue on histopathological analysis | 3 months after ESD initial procedure | 
| Rate of histologically complete (R0) resection of esophageal adenocarcinoma | R0 resection rate = horizontal margins free from cancer, and vertical margins free from carcinoma. | 3 months after ESD initial procedure | 
| Rate of histologically complete (R0) resection of low grade dysplasia | R0 resection rate = horizontal margins free from cancer, high or low grade dysplasia, and vertical margins free from carcinoma. | 3 months after ESD initial procedure | 
| Curative resection rate of adenocarcinoma | R0 resection of adenocarcinoma, with submucosal invasion <500micrometers, absence of poor differenciation or lymphovascular invasion | 3 months after ESD initial procedure | 
| Complication rates | early or late complications of ESD | 3 months | 
| rate of complete remission of adenocarcinoma, high grade dysplasia, low grade dysplasia, and intestinal metaplasia at 1 and 3 years | rate of normal endoscopic and histologic follow-up after ESD | 3 years after initial procedure | 
| rate of buried glands | Presence of Buried glands on histological analysis of follow-up biopsies | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett esophagus, Esophageal adenocarcinoma, Endoscopic submucosal dissection