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OpenTrials
Completed

NCT Number: NCT04348266

RFA for GIM Treatment

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

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Key information

Conditions

Gastric Intestinal Metaplasia Radio-frequency Ablation Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rapat Pittayanon

Pathum Wan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation (RFA)

Device

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.

Primary outcomes

  1. Number of GIM lesions regression

    Time frame: 1 year

    Regression of GIM lesions after RFA treatment compared to no treatment

Secondary outcomes

  1. Number of GIM regression by location

    Time frame: 1 year

    Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment

Sponsors and collaborators

Lead sponsor

King Chulalongkorn Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2020
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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