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

Primary Purpose

Barrett Esophagus, Esophageal Adenocarcinoma, Reflux Disease

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Endoscopic radiofrequency ablation
Endoscopic hybrid argon plasma coagulation
Sponsored by
Centre of Postgraduate Medical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett Esophagus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Centre for Postgraduate EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

radiofrequency ablation

hybrid argon plasma coagulation

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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)
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)

Secondary Outcome Measures

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)
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).
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).

Full Information

First Posted
September 2, 2021
Last Updated
April 27, 2023
Sponsor
Centre of Postgraduate Medical Education
Collaborators
Maria Sklodowska-Curie National Research Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT05051475
Brief Title
Endoscopic Radiofrequency Ablation Versus Hybrid Argon Plasma Coagulation in the Treatment of Barrett's Esophagus
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre of Postgraduate Medical Education
Collaborators
Maria Sklodowska-Curie National Research Institute of Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, Esophageal Adenocarcinoma, Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
radiofrequency ablation
Arm Type
Active Comparator
Arm Description
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).
Arm Title
hybrid argon plasma coagulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic radiofrequency ablation
Intervention Description
Endoscopic ablation technique for Barrett's epithelium
Intervention Type
Procedure
Intervention Name(s)
Endoscopic hybrid argon plasma coagulation
Intervention Description
Endoscopic ablation technique for Barrett's epithelium
Primary Outcome Measure Information:
Title
Level of post-procedural pain
Description
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.
Time Frame
Measured at any time point before given anesthesia for the procedure and immidietly after the procedure.
Title
Level of post-procedural pain at day 7 after treatment
Description
Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)
Time Frame
Measured at day 7 after the procedure
Title
Level of late post-procedural pain (at day 30 after treatment)
Description
Post-procedural chest pain evaluated by the numeric analog scale (NAS) from score 0 (no pain) to 10 (worst possible pain)
Time Frame
Measured at day 30 after the procedure
Secondary Outcome Measure Information:
Title
Level of post-procedural dysphagia
Description
Evaluated by the Mellow-Pinkas scoring from 0 (able to eat normal diet / no dysphagia) to 4 (unable to swallow anything / total dysphagia)
Time Frame
Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.
Title
Level of post-procedural quality of life
Description
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).
Time Frame
Measured before the procedure, immidietly after (30-60mins), and at day 7, and day 30 after the procedure.
Title
The rate of complications
Description
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).
Time Frame
Measured during the prcoedure, immidietly after the procedure and at day 7 and day 30 after the procedure during follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wladyslaw Jannuszewicz, MD
Phone
+48 546-23-28
Email
wjanuszewicz@cmkp.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Jaroslaw Regula, MD, PhD
Phone
+48 546-23-28
Email
jregula@coi.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wladyslaw Januszewicz, MD
Organizational Affiliation
Centre for Postgraduate Medical Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Centre for Postgraduate Education
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslaw Regula, M.D., PhD
Phone
+48 546 23 28
Email
jaroslaw.regula@coi.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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