Endoscopic Resection plus BÂRRX Radiofrequency Ablation for Eradication of Barrett's Mucosa containing High-Grade Dysplasia and Early Cancer. First European Multi-Centre Cohort Study.
Completed
- Conditions
- Barrett's cancer, Barrett's dysplasia, Barrett's esophagus, Radiofrequency ablation, Endoscopic mucosa resection, Barrett's neoplasia, Endoscopic resection
- Registration Number
- NL-OMON27256
- Lead Sponsor
- Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Patients in the age of 18-85 years with HGD or EC in a BE.
Exclusion Criteria
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
- 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