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

Centre of Postgraduate Medical Education

Status: Completed

Conditions: Reflux Disease; Barrett Esophagus; Esophageal Adenocarcinoma

Treatments: Procedure: Endoscopic radiofrequency ablation; Procedure: Endoscopic hybrid argon plasma coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05051475

2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

radiofrequency ablation

Active Comparator group

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).

Treatment:

Procedure: Endoscopic radiofrequency ablation

hybrid argon plasma coagulation

Active Comparator group

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.

Treatment:

Procedure: Endoscopic hybrid argon plasma coagulation