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

NCT05051475 | Completed

• 1 other identifier: 2021
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett Esophagus; Esophageal Adenocarcinoma; Reflux Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Level of post-procedural 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

  Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.

• The rate of complications

  Measured during the prcoedure, immidietly after the procedure and at day 7 and day 30 after the procedure during follow-up

Study Arms (2)

radiofrequency ablation

ACTIVE COMPARATOR

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

hybrid argon plasma coagulation

ACTIVE COMPARATOR

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

Interventions

Endoscopic radiofrequency ablation PROCEDURE

Endoscopic ablation technique for Barrett's epithelium

radiofrequency ablation

Endoscopic hybrid argon plasma coagulation PROCEDURE

Endoscopic ablation technique for Barrett's epithelium

hybrid argon plasma coagulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead
• Maria Sklodowska-Curie National Research Institute of Oncology: collaborator

Study Sites (1)

Medical Centre for Postgraduate Education

Warsaw, 02-781, Poland

Location

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Wladyslaw Januszewicz, MD

  Centre for Postgraduate Medical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 21, 2021
• Study Start: December 1, 2021
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)