跳至主要内容
临床试验/NCT03463668
NCT03463668招募中不适用

Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years

Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Dysphagia assessment

研究概览

简要总结

To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia

详细描述

Duodenal prostheses have become, since the 2000s, the first-line treatment of unresectable duodenal tumoral stenosis. The technical success is greater than 90%, however the endoscopic revisions that are duodenal or biliary are frequent. The IPC as a center of interventional endoscopy is very often in charge of these stenoses. We wanted to evaluate the efficiency and the duration of this effectiveness in current situation. Is there still room for gastrojejunal gastrojejunal surgery or for the development of endoscopic gastrojejunal anastomoses?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.

排除标准

  • Benign stenosis or covered metallic duodenal prosthesis (usually indicated for benign disease)

结局指标

主要结局

Dysphagia assessment

时间窗: 7 years

GOOSS = Gastric Outlet Obstruction Scoring System

次要结局

  • Rate of complications(7 years)
  • postoperative survival(7 years)
  • Permeability duration of the duodenal stent(7 years)
  • Rate of duodenal endoscopic resection at 1 and 3 months postoperatively(at 1 and 3 months postoperatively)
  • Rate of biliary endoscopic resection at 1 and 3 months postoperatively(at 1 and 3 months postoperatively)

研究者

发起方
Institut Paoli-Calmettes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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