TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE
研究概览
简要总结
safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).
详细描述
Evaluation of the ability of this system to have a complete resection of superficial tumors of the digestive tract (that is to say a resection with free lateral and deep margins without residual tumor tissue)
Evaluation of the ability of such system to inject a viscous macromolecular solution of glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M, Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004;36:579-583.)
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OVER 18 YEARS OLD
- •PATIENTS AGREED WITH THE STUDY
- •SCORE ASA 1 OR 2
- •Patient recorded in a social safety organism
- •patients presenting with superficial lesions with an endoscopic indication of resection
排除标准
- •under 18 years old
- •Patients not agreed with the study
- •pregnant women
- •patient included in an another study
- •medical treatments (radiotherapy, surgery endoscopis treatements) before the intervention
- •coagulation disorders
- •score asa over 3
- •patients with another neoplasic lesion
结局指标
主要结局
SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE
时间窗: 18 months
inclusion duration is about 6 months the following period will be about 12 months so a total duration of 18 months
次要结局
未报告次要终点
研究者
Jean Christophe Saurin
Thieery Ponchon
Hôpital Edouard Herriot