Single step treatment using radiofrequency ablation and endoscopic resection for Barrett esophagus containing early neoplasia in an endoscopically visible abnormality.
Completed
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Age between 18 and 85 years inclusive;
2. BE with a minimal circumferential extent of 2 cm;
Exclusion Criteria
1. Any prior endoscopic treatment for esophageal adenocarcinoma of BE associated neoplasia;
2. Signs of local or distant metastasis on EUS (EUS is obligatory);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The percentage of BE regression at 3 months follow-up after the combined ER and RFA procedure;<br /><br>2. The rate of acute (i.e. < 3 days) complications after therapeutic procedures;<br /><br>3. The rate of late (such as esophageal stenosis) complications occurring during the treatment phase or during follow-up.
- Secondary Outcome Measures
Name Time Method 1. The rate of complete remission of HGD and EC in all biopsies obtained at 12 months follow-up;<br /><br>2. The rate of complete remission of BE, defined as the endoscopic absence of columnar lined epithelium upon inspection with NBI and the absence of intestinal metaplasia in all biopsy specimens obtained at 12 months follow-up;<br /><br>3. The number of endoscopic therapeutic procedures;<br /><br>4. The frequency, severity, and duration of patient's symptoms after the first therapeutic session as assessed with standardised questionnaires and patient diaries;<br /><br>5. Maximum depth of injury (a) complete epithelial ablation, (b) maximum depth of ablation assessed as epithelium, lamina propria, muscularis mucosa, submucosa ('ablation' defined as any sign of irreversible injury: coagulum, loss of cellular architecture, and loss of nuclei).