NCT02583087

ESD for the Treatment of Early Barrett's Neoplasia

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Hôpital Cochin · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barrett Esophagus
• Esophageal Neoplasm

Interventions

Type	Name	Description
PROCEDURE	endoscopic submucosal dissection	Endoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc.

Timeline

• Start date: 2016-01-02
• Primary completion: 2019-04-01
• Completion: 2022-04-01
• First posted: 2015-10-21
• Last updated: 2017-08-28

Locations

1 site across 1 country: France