Back to resultsRFA for GIM Treatment
Primary Purpose
Gastric Intestinal Metaplasia, Treatment, Radio-frequency Ablation
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Radiofrequency ablation (RFA)
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Intestinal Metaplasia
Eligibility Criteria
Inclusion Criteria:
- More than 18 years of age
- Previous diagnose of GIM
- Able to sign the consent
Exclusion Criteria:
- No GIM at first endoscopy
- Previous gastric surgery
- Coagulopathy
- Pregnancy or lactation
- Have contraindication for RFA treatment
Sites / Locations
- Rapat Pittayanon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
RFA
Control
Arm Description
The assigned location will be treated with RFA at all lesion.
No treatment will not be performed at this location. However, if endoscopist detects any suspicious lesion during the scheduled endoscopy, the biopsy will be done and standard treatment will be performed accordingly.
Outcomes
Primary Outcome Measures
Number of GIM lesions regression
Regression of GIM lesions after RFA treatment compared to no treatment
Secondary Outcome Measures
Number of GIM regression by location
Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment
Full Information
NCT ID
NCT04348266
First Posted
April 12, 2020
Last Updated
July 29, 2023
Sponsor
King Chulalongkorn Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04348266
Brief Title
RFA for GIM Treatment
Official Title
Efficacy of Radiofrequency Ablation in Treatment of Gastric Intestinal Metaplasia: a Randomized, Self-control Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Chulalongkorn Memorial Hospital
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
Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment.
Detailed Description
Gastric intestinal metaplasia (GIM) is a pre-malignant lesion. Currently, there is no standard treatment for this condition, thus the patients with GIM need surveillance endoscopy every 1-3 years, regarding to the severity and extension of lesion. However, the protocol for GIM surveillance is uncertain and need high cost.
Radiofrequency ablation (RFA) is used for Barrett's esophagus (BE; pre-malignant lesion of esophageal adenoCA) treatment as a standard treatment. The investigators hypothesized that RFA may effective in GIM treatment.
The investigators will random GIM participants to have the RFA treatment only one site of the stomach (left or right). At the first session, the investigators will biopsy at suspected GIM lesions to confirm the diagnosis and severity of GIM. Two months later, The investigators will apply RFA to all GIM lesions at the assigned location and then every 2 months for 3 sessions or until no GIM lesion seen by endoscopy. The final endoscopy will be done at 1 year follow-up and biopsy will be performed to assess the efficacy of RFA compare to no treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Intestinal Metaplasia, Treatment, Radio-frequency Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study in only GIM patients but will divide the stomach into 2 sites (left and right) to random for RFA treatment.
Masking
Outcomes Assessor
Masking Description
The endoscopist who do the final endoscopy for assessing the efficacy of RFA will be blinded to the previous assigned location of RFA treatment.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RFA
Arm Type
Experimental
Arm Description
The assigned location will be treated with RFA at all lesion.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment will not be performed at this location. However, if endoscopist detects any suspicious lesion during the scheduled endoscopy, the biopsy will be done and standard treatment will be performed accordingly.
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation (RFA)
Intervention Description
Radiofrequency ablation is a device that can generate the heat from radiofrequency for tissue ablation. RFA is a standard treatment for Barrett' esophagus and high grade dysplasia in esophagus.
Primary Outcome Measure Information:
Title
Number of GIM lesions regression
Description
Regression of GIM lesions after RFA treatment compared to no treatment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of GIM regression by location
Description
Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
More than 18 years of age
Previous diagnose of extensive or incomplete GIM
Exclusion Criteria:
No GIM at first endoscopy
Previous gastric surgery
Coagulopathy
Pregnancy or lactation
Unable to perform appropriate peri-procedural cessation of antiplatelet/antithrombotic therapy
Unable to sign the consent
Facility Information:
Facility Name
Rapat Pittayanon
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Do not share IPD to other researchers
Learn more about this trial
RFA for GIM Treatment
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