RFA for GIM Treatment

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    56
  • sponsor
    King Chulalongkorn Memorial Hospital
Updated on 22 April 2022

Summary

Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment.

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.

Details
Condition Gastric Intestinal Metaplasia, Treatment, Radio-frequency Ablation
Treatment radiofrequency ablation (RFA)
Clinical Study IdentifierNCT04348266
SponsorKing Chulalongkorn Memorial Hospital
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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