ESD for the Treatment of Early Barrett's Neoplasia (ESTEBAN)

Hôpital Cochin

Status: Unknown

Conditions: Barrett Esophagus; Esophageal Neoplasm

Treatments: Procedure: endoscopic submucosal dissection

Study type: Observational

Funder types: Other

Identifiers

NCT02583087

20102015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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