RFA for GIM Treatment

Not Applicable

Completed

• Conditions: Gastric Intestinal Metaplasia; Treatment; Radio-frequency Ablation
• Interventions: Device: Radiofrequency ablation (RFA)

• Registration Number: NCT04348266
• Lead Sponsor: King Chulalongkorn Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2020-04-12
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Study Start: 2020-06-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-05-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-29
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA	Radiofrequency ablation (RFA)	The assigned location will be treated with RFA at all lesion.

Primary Outcome Measures

Name	Time	Method
Number of GIM lesions regression	1 year	Regression of GIM lesions after RFA treatment compared to no treatment

Secondary Outcome Measures

Name	Time	Method
Number of GIM regression by location	1 year	Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment

Trial Locations

Locations (1)

Rapat Pittayanon; 🇹🇭 Pathum Wan, Bangkok, Thailand