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

NCT ID: NCT05051475

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-05-05

Brief Summary

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

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.

Conditions

Barrett Esophagus; Esophageal Adenocarcinoma; Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

radiofrequency ablation

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).

Group Type: ACTIVE_COMPARATOR

Endoscopic radiofrequency ablation

Intervention Type: PROCEDURE

Endoscopic ablation technique for Barrett's epithelium

hybrid argon plasma coagulation

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic hybrid argon plasma coagulation

Intervention Type: PROCEDURE

Endoscopic ablation technique for Barrett's epithelium

Interventions

Endoscopic radiofrequency ablation

Endoscopic ablation technique for Barrett's epithelium

Intervention Type: PROCEDURE

Endoscopic hybrid argon plasma coagulation

Endoscopic ablation technique for Barrett's epithelium

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: collaborator

Centre of Postgraduate Medical Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wladyslaw Januszewicz, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Postgraduate Medical Education

Locations

Medical Centre for Postgraduate Education

Warsaw, , Poland

Countries

Poland

Other Identifiers

2021

Identifier Type: -

Identifier Source: org_study_id