Clinical Trials Directory

Trials / Completed

CompletedNCT05051475

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

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)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
62 (actual)
Sponsor
Centre of Postgraduate Medical Education · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREEndoscopic radiofrequency ablationEndoscopic ablation technique for Barrett's epithelium
PROCEDUREEndoscopic hybrid argon plasma coagulationEndoscopic ablation technique for Barrett's epithelium

Timeline

Start date
2021-12-01
Primary completion
2025-05-05
Completion
2025-05-05
First posted
2021-09-21
Last updated
2025-10-03

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT05051475. Inclusion in this directory is not an endorsement.