ESD for the Treatment of Early Barrett's Neoplasia

• Conditions: Barrett Esophagus; Esophageal Neoplasm

• Registration Number: NCT02583087
• Lead Sponsor: Hôpital Cochin

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Study Start: 2016-01-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28
• Primary Completion: 2019-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cochin Hospital; 🇫🇷 Paris, France