跳至主要内容
临床试验/CTRI/2017/07/009182
CTRI/2017/07/009182尚未招募不适用

A prospective pilot study to assess safety and feasibility of anti reflux mucosectomy for gastroesophageal reflux disease

Endoscopy Research foundation1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年8月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
To alleviate GERD symptoms without any adverse effects to the patient

研究概览

简要总结

Crescentic ARMS of the esophagogastric junctional (EGJ) mucosa will be conducted with the now standardized techniques of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD), of at least 3 cm length (1 cm in the esophagus and 2 cm in the stomach), with the length of mucosal resection at the cardia measured in retroflexion from the gastric side. ARMS was conducted along the side of the lesser curve of the stomach, thus preserving a sharp mucosal valve at gastric cardia.

Results suggest a potential anti-reflux effect of ARMS. The mechanism is presumed to be due to scar formation after healing of the mucosal defect . On the gastric side, this induces narrowing of the gastric cardia opening, while preserving and/or re-creating a robust his angle. We also postulate some remodeling of mucosal flap valve as an effective antireflux mechanism at this anatomical level.

As demonstrated in , after ARMS, the lesser curve of the gastric cardia takes on an almost “mechanically-stitched†appearance. The mucosal flap is rebuilt and looks well-defined. Furthermore, the lesser curve side of the EGJ is shortened with scar formation, and greater curve of EGJ (his angle side) is kept non-scarred and therefore retains its flexibility as a mucosal flap valve. Another major advantage of this procedure is that it requires no proprietary equipment and leaves no artificial prostheses in situ (which could generate a foreign body reaction in the future).

Although possible complications may include perforation or bleeding, the techniques of EMR/ESD used in this procedure have become standardized and popularized. These risks are likely to be minimal in “expert†hands and, even if experienced, can be resolved using standardized endoscopic recovery techniques such as coagulation forceps or clips for bleeding and perforation . Furthermore, piecemeal EMR could be a less time-consuming and acceptable (sole) technique in this procedure, particularly if the specimen involves no dysplasia.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients with gastroesophageal reflux disease.

排除标准

  • 1>Patients who are below 18 years age 2>Patients who are pregnant or breast feeding 3>Patients who are unable to give consent 4>Patients with hiatus hernia, patients not fit for general anaesthesia.
  • 5>Patients with NERD, Hypersensitive oesophagus 6>Patients with oesophageal dysmotility.

结局指标

主要结局

To alleviate GERD symptoms without any adverse effects to the patient

时间窗: week 4, 12

次要结局

  • Technical success- This is defined as an adequate mucosectomy on the oesophageal and gastric side has been achieved(Treatment success- Relief from the symptoms of GERD, stopping of PPI therapy with normalizing of 24 pH test.)

研究者

申办方类型
Research institution

研究点 (1)

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