Efficacy of Radiofrequency Ablation in Treatment of Gastric Intestinal Metaplasia: a Randomized, Self-control Study
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
- 否
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
Rapat Pittayanon
Principle investigator
King Chulalongkorn Memorial Hospital
