Endoscopic Resection plus BÂRRX Radiofrequency Ablation for Eradication of Barrett's Mucosa containing High-Grade Dysplasia and Early Cancer.A European Multi-Centre Cohort Study.

Completed

• Conditions: Barrett's esophagus; Barrett's oesophagus; Barrett slokdarm; Barrett's neoplasia; Barrett's cancer; Barrett neoplasie; Barrett carcinoom; Barrett's dysplasia; Barrett dysplasie; Radiofrequency ablation

• Registration Number: NL-OMON28564
• Lead Sponsor: Academic Medical CenterDept. of Gastroenterology and Hepatology

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Inclusion criteria prior to Endoscopic Resection:

1. Patients in the age of 18-85 years with HGD or EC in a Barrett's esophagus.

Exclusion Criteria

Exclusion criteria prior to Endoscopic Resection:

1. Patients with a Barrett's segment >12 centimeters.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary clinical outcome parameters assessed at t=6 and t=12 months: <br /><br>1. Rate of total histological eradication of HGD and EC <br /><br>2. Rate of total endoscopic eradication of Barrett's mucosa <br /><br>3. Rate of total histological eradication of Barrett's mucosa <br />

Secondary Outcome Measures

Name	Time	Method
Secondary outcome parameters <br /><br>1. Acute and late complications of ER and RFA <br /><br>2. Percentage of surface regression of Barrett's epithelium <br /><br>3. Number of treatment sessions required to eradicate all Barrett's mucosa