RFA for GIM Treatment

Sponsor
King Chulalongkorn Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04348266
Collaborator
(none)
56
1
2
36
1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Radiofrequency ablation (RFA)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Study in only GIM patients but will divide the stomach into 2 sites (left and right) to random for RFA treatment.Study in only GIM patients but will divide the stomach into 2 sites (left and right) to random for RFA 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.
Primary Purpose:
Treatment
Official Title:
Efficacy of Radiofrequency Ablation in Treatment of Gastric Intestinal Metaplasia: a Randomized, Self-control Study
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: RFA

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

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.

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

  1. Number of GIM lesions regression [1 year]

    Regression of GIM lesions after RFA treatment compared to no treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rapat Pittayanon Pathum Wan Bangkok Thailand 10330

Sponsors and Collaborators

  • King Chulalongkorn Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rapat Pittayanon, Principle investigator, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04348266
Other Study ID Numbers:
  • RP020
First Posted:
Apr 16, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022