跳至主要内容
临床试验/NCT04049955
NCT04049955已完成不适用

Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique : an Interventional Multicentric and Prospective Study.

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年8月1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
150
试验地点
2
主要终点
Number of Participants with Fistula Healing at week 18

研究概览

简要总结

Obesity is a major health problem in western countries, and sleeve gastrectomy has proven its effectiveness on weight loss and improvement of comorbidities related to obesity. The main complication is the occurrence of upper fistula (2%), and may be responsible of several deaths.

There is no consensus on medical, radiological and surgical management of fistula. It depends on the resources of each center and is based on a low level evidence The inconstant efficacy of the endoscopic treatment by closing fistula (digestive stents, clips, glue) motivates a new endoscopic approach. It consists of an internal drainage of the collection by using double pigtail stents through the fistulous orifice.

详细描述

Partially or fully covered stents are the most used method, but are not supported by any comparative studies. Their results are inconstant and the closure rate is estimated between 15 and 100%, with a hazardous median healing time. This method is associated with frequent complications, such as spontaneous migrations, impactions or ulcerations responsible for potentially fatal hematemesis. The preliminary results of using OTSC clips (OVESCO®) seem encouraging, but this technique requires external drainage to obtain a collection free from infection. A new approach is to perform an internal drainage of the peri-orificial collection by using double pigtail stents through the fistulous orifice and to direct the fistula closure from the outside to the inside. This endoscopic treatment, combined with nutritional support and initial antibiotic therapy, allows rapid weaning of external drainage and short healing times. CT and endoscopic evaluation are needed at the sixth week for stents removal in the event of a favorable evolution. In the opposite case, a second endoscopic treatment is performed. In case of unfavorable evolution, a radical surgical treatment, in the absence of endoscopic alternative, will be achieved.

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

  • Any major patient hospitalized for a symptomatic fistula after sleeve gastrectomy, outside the exclusion criteria, is eligible.
  • Free, informed and signed consent
  • Affiliation to the social security system

排除标准

  • Other surgery than Sleeve gastrectomy
  • Fistula located at a site other than the upper pole of the staple line
  • Fistulization on the upper diaphragmatic floor
  • Fistulous orifice larger than 25 mm
  • Pregnancy
  • Patient under guardianship or curators or deprived of public law

结局指标

主要结局

Number of Participants with Fistula Healing at week 18

时间窗: week 18 after endoscopy

Number of Participants with Healing at week 18

次要结局

  • Number of Participants with Fistula Healing at week 6(week 6 after endoscopy)
  • Measure of length of hospital stay(up to week 18 after endoscopy)
  • Number of Participants with Fistula Healing at week 12(week 12 after endoscopy)
  • Number of Participants with Fistula delay(up to week 18 after endoscopy)
  • Number of Participants with gastric stenosis(up to week 18 after endoscopy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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