ESD for the Treatment of Early Barrett's Neoplasia

Hôpital Cochin150 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

Barrett Esophagus Esophageal Neoplasm

Interventions

endoscopic submucosal dissectionPROCEDURE

Endoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Cochin Hospital

Paris, France

RECRUITING

Outcomes

Primary Outcomes

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.