Clinical trial · Interventional
Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus
Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus - the Patients' Perspective: a Randomized Controlled Trial Assessing Procedural Acceptability and Safety (RATE Study)
NCT05051475CI-TRIAL-00096229RATEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study compares patients' acceptability and safety of two established endoscopic methods for treating dysplastic Barrett's esophagus: radiofrequency ablation versus hybrid argon plasma coagulation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Reflux Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic hybrid argon plasma coagulation | Procedure | — | UNRESOLVED |
| Endoscopic radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- radiofrequency ablation
- description
- 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).
- interventionNames
- Procedure: Endoscopic radiofrequency ablation
- type
- ACTIVE_COMPARATOR
- label
- hybrid argon plasma coagulation
- description
- 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.
- interventionNames
- Procedure: Endoscopic hybrid argon plasma coagulation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.