Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus

Study Overview
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Brief Summary
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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.

Detailed Description
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Both endoscopic radiofrequency ablation (RFA) and argon plasma coagulation (APC) are established treatment modalities for dysplastic Barrett's esophagus. Recently, a modification of the APC method has emerged, which involves a submucosal injection of saline preceding the thermal ablation (hybrid-APC; h-APC). This allows to increase the procedure's safety and presumably reduces the patients' post-procedural discomfort. Although both RFA and h-APC are characterized by high effectiveness in eradicating Barrett's segments, limited data compares the patient-related aspects of the procedures. To fill this knowledge gap, we set out a single-center randomized-controlled trial to compare procedural acceptability, safety, and impact on the quality of life, of the two methods.

Official Title
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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)

Conditions
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Barrett Esophagus, Esophageal Adenocarcinoma, Reflux Disease

Intervention / Treatment
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* Procedure: Endoscopic radiofrequency ablation
* Procedure: Endoscopic hybrid argon plasma coagulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: radiofrequency ablation<br>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). | Procedure: Endoscopic radiofrequency ablation<br>* Endoscopic ablation technique for Barrett's epithelium<br>|
| Active Comparator: hybrid argon plasma coagulation<br>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. | Procedure: Endoscopic hybrid argon plasma coagulation<br>* Endoscopic ablation technique for Barrett's epithelium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of post-procedural pain | Change in chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain) before the procedure and immidietly after (30-60 minutes) the procedure. | Measured at any time point before given anesthesia for the procedure and immidietly after the procedure. | 
| Level of post-procedural pain at day 7 after treatment | Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain) | Measured at day 7 after the procedure | 
| Level of late post-procedural pain (at day 30 after treatment) | Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain) | Measured at day 30 after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of post-procedural dysphagia | Evaluated by the Mellow-Pinkas scoring from 0 (able to eat normal diet / no dysphagia) to 4 (unable to swallow anything / total dysphagia) | Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure. | 
| Level of post-procedural quality of life | Evaluated by the QLQ-OES18 questionnaire specific for esophageal symptoms, and consists of a symptom scale only. The QLQ-OES18 includes 18 questions: 6 single item subscales relating to saliva swallowing, choking, dry mouth, taste, coughing, and talking. It also includes 12 items grouped into 4 subscales: dysphagia (3 items), eating (4 items), reflux (2 items), and pain (3 items). | Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure. | 
| The rate of complications | Intra-procedural complications, such as bleeding, perforation, post-procedural complications, e.g. chest-pain, esophageal stricture will be monitored during the hospital stay and follow-up at day 7 and day 30 after the procedure (phone call). | Measured during the prcoedure, immidietly after the procedure and at day 7 and day 30 after the procedure during follow-up |