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

Last updated: April 27, 2023
Sponsor: Centre of Postgraduate Medical Education
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Adenocarcinoma

Esophageal Cancer

Treatment

N/A

Clinical Study ID

NCT05051475
2021
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subjects over 18 years
  • Histologically and endoscopically proven Barrett's esophagus requiring ablationtherapy according to the current guidelines
  • General health status sufficient to perform an endoscopic procedure (ASA I-III)

Exclusion

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 withholdthe medication temporarily
  • Recent myocardial infraction or other significant cardiovascular event within 6 monthsprior to recruitment
  • Patients under long-term care and/or within nursing facilities (e.g. psychosocialdisorders, mental retardation)
  • Any history of esophageal resection surgery
  • Esophageal varices

Study Design

Total Participants: 40
Study Start date:
December 01, 2021
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Medical Centre for Postgraduate Education

    Warsaw, 02-781
    Poland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.