Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus (RATE)
Barrett Esophagus, Esophageal Adenocarcinoma, Reflux Disease
About this trial
This is an interventional treatment trial for Barrett Esophagus
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects over 18 years
- Histologically and endoscopically proven Barrett's esophagus requiring ablation therapy according to the current guidelines
- General health status sufficient to perform an endoscopic procedure (ASA I-III)
Exclusion Criteria:
- Primary or secondary coagulopathy, with INR>1.5 and/or platelet count of <75,000.
- Anticoagulation therapy (e.g. warfarin) for high-risk condition and unable to withhold the medication temporarily
- Recent myocardial infraction or other significant cardiovascular event within 6 months prior to recruitment
- Patients under long-term care and/or within nursing facilities (e.g. psychosocial disorders, mental retardation)
- Any history of esophageal resection surgery
- Esophageal varices
Sites / Locations
- Medical Centre for Postgraduate EducationRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
radiofrequency ablation
hybrid argon plasma coagulation
Circumferential ablation with radiofrequency ablation will be performed for each segment of the BE starting from the proximal end with one ablation at 12J/cm2, followed by cleaning of mucosal slough with esophageal cap, patient extubation, cleaning of ablation device with wet gauze, and finally a second ablation at 12 J/cm2 (1 × 12J/cm2-clean-1 × 12 J/cm2). Focal ablations will be performed with three consecutive ablations at 12 J/cm2 without cleaning (simplified protocol).
Patients in the Hybrid argon plasma coagulation group will be treated with a single ablation per session with a power limitation of 60 W (pulsed mode (VIO® 300 D & APC 2, PULSED APC®, Effect 2). No scraping with the endoscope cap and second ablation will be performed.