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NCT04348266 Clinical Trial

RFA for GIM Treatment

Treatment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04348266
Other study ID # RP020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date May 31, 2023

Study information
Verified date July 2023
Source King Chulalongkorn Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date May 31, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Thailand Rapat Pittayanon Pathum Wan Bangkok

Sponsors (1)
Lead Sponsor Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of GIM lesions regression Regression of GIM lesions after RFA treatment compared to no treatment 1 year
Secondary Number of GIM regression by location Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment 1 year
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