Clinical trial NCT05051475: Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Barrett Esophagus
Esophageal Adenocarcinoma
Reflux Disease
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
Collaborators: name: Maria Sklodowska-Curie National Research Institute of Oncology
First posted: 2021-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Level of post-procedural pain
timeFrame: Measured at any time point before given anesthesia for the procedure and immidietly after the procedure.
measure: Level of post-procedural pain at day 7 after treatment
timeFrame: Measured at day 7 after the procedure
measure: Level of late post-procedural pain (at day 30 after treatment)
timeFrame: Measured at day 30 after the procedure
Secondary outcomes:
measure: Level of post-procedural dysphagia
timeFrame: Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.
measure: Level of post-procedural quality of life
timeFrame: Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.
measure: The rate of complications
timeFrame: Measured during the prcoedure, immidietly after the procedure and at day 7 and day 30 after the procedure during follow-up
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical Centre for Postgraduate Education
Study officials:
affiliation: Centre for Postgraduate Medical Education
name: Wladyslaw Januszewicz, MD
role: PRINCIPAL_INVESTIGATOR
References: