Gastric Intestinal Metaplasia, Radio-frequency Ablation, Treatment
Conditions
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.
Interventions
DEVICERadiofrequency 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.
Sponsors
King Chulalongkorn Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The endoscopist who do the final endoscopy for assessing the efficacy of RFA will be blinded to the previous assigned location of RFA treatment.
Intervention model description
Study in only GIM patients but will divide the stomach into 2 sites (left and right) to random for RFA treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of GIM lesions regression | 1 year | Regression of GIM lesions after RFA treatment compared to no treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of GIM regression by location | 1 year | Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment |
Countries
Thailand
Outcome results
None listed