跳至主要内容
临床试验/NCT03357809
NCT03357809暂停不适用

Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease

Hospital St. Joseph, Marseille, France2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
15
试验地点
2
主要终点
Rate of patients no longer requiring medical treatment at 6 months

研究概览

简要总结

Currently patients with gastroesophageal reflux disease (GERD) are treated with proton pump inhibitors (PPIs). This long-term PPI treatment would likely increase the risk of pulmonary and digestive infections and would not prevent evolution to adenocarcinoma of Barrett's Esophagus. Surgical fundoplication is generally recommended when symptoms are poorly controlled with PPIs and considered as standard treatment despite celioscopy risk. A variety of endoscopic techniques for the treatment of GERD has been proposed to obtain non-surgical control. These endoscopic techniques aim to bring the tissues closer to the Œsogastric (JOG) junction. But a low response rate has been demonstrated with these techniques.

H. Inoue (inventor of the anti-reflux mucosectomy 20 years ago) and his team postulated that the reflux symptoms would be reduced by creating a relative restriction of gastric cardia. The healing of the mucosectomy zone led to restriction of gastric cardia. This observation suggested that ARMS could represent an effective anti-reflux procedure with the advantage that no prostheses would be left in situ.

Few studies have evaluated this new endoscopic technique. The purpose of this study is to evaluate the feasibility and safety of gastric mucosectomy for patients with GERD resistant to medical treatment or requiring long-term maintenance medical treatment.

详细描述

This is a monocentric prospective therapeutic study. Patients will be recruited in hepato-gastroenterology department of Saint Joseph Hospital (Marseille). A first clinical, endoscopic and PH impedance evaluation will be made. Mucosectomy will be scheduled depending on the results of the review.

The patients will be followed for 2 years with esophageal and gastric PH-impedance monitoring at 6 months and 24 months. Health related quality of life questionnaires will be completed before ARMS, 6 and 24 months after mucosectomy.

The characteristics of the patients will be compared to evaluate the % of responders and non-responders

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Patient with GERD resistant to medical treatment, or requiring daily long-term medical treatment

排除标准

  • Contraindications to the realization of a upper GI endoscopy
  • Achalasia or other esophageal motor disorders
  • Voluminous hiatal hernia Haemorrhagic, haemostasis or coagulation disorders

研究组 & 干预措施

Endoscopic treatment

Experimental

ENDOSCOPIC MUCOSAL RESECTION AT DAY 1

干预措施: Endoscopic mucosal resection (Procedure)

结局指标

主要结局

Rate of patients no longer requiring medical treatment at 6 months

时间窗: 6 months

Suggest that endoscopic treatment would allow the cessation of medical treatment in 50% of cases Rate of patients no longer requiring medical treatment at 6 months

次要结局

  • Improvement in quality of life(6 months)
  • Improvement of gastric PH(6 months)
  • Evaluation for morbidity(30 days)

研究者

发起方
Hospital St. Joseph, Marseille, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arthur Laquiere

Principal investigator

Hospital St. Joseph, Marseille, France

研究点 (2)

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