RFA for GIM Treatment

Study Overview
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Brief Summary
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Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment.

Detailed Description
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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.

Official Title
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Efficacy of Radiofrequency Ablation in Treatment of Gastric Intestinal Metaplasia: a Randomized, Self-control Study

Conditions
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Gastric Intestinal Metaplasia, Treatment, Radio-frequency Ablation

Intervention / Treatment
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* Device: Radiofrequency ablation (RFA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study in only GIM patients but will divide the stomach into 2 sites (left and right) to random for RFA treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA<br>The assigned location will be treated with RFA at all lesion. | Device: Radiofrequency ablation (RFA)<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of GIM lesions regression | Regression of GIM lesions after RFA treatment compared to no treatment | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of GIM regression by location | Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment | 1 year |