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

Barrett Esophagus Clinical Trial

— RATE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051475
• Other study ID #: 2021
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Centre of Postgraduate Medical Education
• Contact: Wladyslaw Jannuszewicz, MD
• Phone: +48 546-23-28
• Email: wjanuszewicz[@]cmkp.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Adenocarcinoma
• Reflux Disease

Intervention

Procedure:
• Endoscopic radiofrequency ablation
Endoscopic ablation technique for Barrett's epithelium
• Endoscopic hybrid argon plasma coagulation
Endoscopic ablation technique for Barrett's epithelium

Locations

Country	Name	City	State
Poland	Medical Centre for Postgraduate Education	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education	Maria Sklodowska-Curie National Research Institute of Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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