RFA for GIM Treatment

King Chulalongkorn Memorial Hospital

Status: Completed

Conditions: Treatment; Gastric Intestinal Metaplasia; Radio-frequency Ablation

Treatments: Device: Radiofrequency ablation (RFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04348266

RP020

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

RFA

Experimental group

Description:

The assigned location will be treated with RFA at all lesion.

Treatment:

Device: Radiofrequency ablation (RFA)

Control

No Intervention group

Description:

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.