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

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)

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.

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus; Esophageal Adenocarcinoma; Reflux Disease
• Intervention / Treatment: Procedure: Endoscopic radiofrequency ablation; Procedure: Endoscopic 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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-781
    • Medical Centre for Postgraduate Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: Endoscopic radiofrequency ablation; Endoscopic ablation technique for Barrett's epithelium
Active Comparator: 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.	Procedure: Endoscopic hybrid argon plasma coagulation; Endoscopic ablation technique for Barrett's epithelium

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre of Postgraduate Medical Education
• Collaborators: Maria Sklodowska-Curie National Research Institute of Oncology
• Investigators: Principal Investigator: Wladyslaw Januszewicz, MD, Centre for Postgraduate Medical Education

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): May 5, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; Barrett Esophagus; Adenocarcinoma Of Esophagus
• Other Study ID Numbers: 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No