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临床试验/NCT02739074
NCT02739074已完成不适用

Effectiveness of Metal Protheses Covered in "Diabolo" in Treatment of Necrosis of Origin Pancreatic: Trial "DIABOLOPIG"

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2016年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Rate of patients who complete treatment of pancreatic necrosis

研究概览

简要总结

Endoscopic treatment of pancreatic necrosis complicated by trans digestive track (duodenal or gastric) has become a standard technique validated. The rate of high technical and clinical success (76 to 91% in 3 months) and the lower morbidity in the literature explains that validation. However this treatment is done at the cost of a higher median number of treatment sessions (4-5) explaining prolonged hospitalization, delays in rehabilitation and potentially high costs. The constant improvement of therapeutic endoscopy equipment was allowed to see the advent of metal prosthesis completely covered by a membrane allowing them endoscopic extraction with ease. It has thus been recently developed short prostheses, of large diameter (up to 15/16 mm), with broad flange (or stent "diabolo") to be considered for use in the drainage of digestive peri collections. Few studies respectively determined the effectiveness of this type of prosthesis in the drainage of peri digestive collections Under echo endoscopy and treatment of necrosis of pancreatic origin. The purpose of this work is to evaluate multicenter prospective clinical and technical efficiency of laying completely covered stent "diabolo" in echo endoscopy for the treatment of necrosis of pancreatic origin.

研究设计

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

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

  • Presence of peri gastric or duodenal collection type WOPN to imaging according to the Atlanta criteria (Banks Gut 2013) with predominantly solid component (> 50%) for imaging, requiring necrosectomy for:
  • Pain and / or,
  • necrosis infection (positive necrosis culture, gas bubble presence in the collection on imaging, persistent sepsis or deterioration of the patient's condition despite optimal reanimation support without documented infection) and / or,
  • High Occlusion (vomiting, food intolerance and gastric stasis at imaging)

排除标准

  • Severe coagulation disorders or hemostasis

结局指标

主要结局

Rate of patients who complete treatment of pancreatic necrosis

时间窗: 3 months

Rate of patients who complete treatment of pancreatic necrosis was obtained (\> 80% and amendment of symptoms) after a single necrosectomy endoscopic session with a covered metal prosthesis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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