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临床试验/NCT04348266
NCT04348266已完成不适用

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

King Chulalongkorn Memorial Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Number of GIM lesions regression

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The endoscopist who do the final endoscopy for assessing the efficacy of RFA will be blinded to the previous assigned location of RFA treatment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • More than 18 years of age
  • Previous diagnose of extensive or incomplete GIM

排除标准

  • 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

结局指标

主要结局

Number of GIM lesions regression

时间窗: 1 year

Regression of GIM lesions after RFA treatment compared to no treatment

次要结局

  • Number of GIM regression by location(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rapat Pittayanon

Principle investigator

King Chulalongkorn Memorial Hospital

研究点 (2)

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