RFA for GIM Treatment
Study Details
Study Description
Brief Summary
Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment.
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: RFA The assigned location will be treated with RFA at all lesion. |
Device: Radiofrequency ablation (RFA)
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.
|
No Intervention: Control 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. |
Outcome Measures
Primary Outcome Measures
- Number of GIM lesions regression [1 year]
Regression of GIM lesions after RFA treatment compared to no treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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More than 18 years of age
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Previous diagnose of GIM
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Able to sign the consent
Exclusion Criteria:
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No GIM at first endoscopy
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Previous gastric surgery
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Coagulopathy
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Pregnancy or lactation
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Have contraindication for RFA treatment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Rapat Pittayanon | Pathum Wan | Bangkok | Thailand | 10330 |
Sponsors and Collaborators
- King Chulalongkorn Memorial Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RP020