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临床试验/NCT02193789
NCT02193789已完成不适用

The Effect of Newly Designed Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration in Benign Stricture of Gastroduodenal Anastomosis: a Pilot Study

Ajou University School of Medicine2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
2
主要终点
Improvement of symptom (Resolving anastomosis site stricture)

研究概览

简要总结

In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis site stricture is very severe complication. It can improve by temporary through the scope covered metallic stent. It is very effective procedure about the stricture. But stent migration is very severe complication. Herein the investigators suggest newly method to prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent stent migration. But it is difficult to remove stent after resolved stricture. So the investigators add the suture between hemoclip and stent. And the investigators cut the suture when stent removal.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •subtotal gastrectomy with Billroth-I or Billroth-II anastomosis
  • •symptom of gastric outlet obstruction
  • •anastomosis site stricture after surgery

排除标准

  • •patients of the impossible stent insertion due to other complication
  • •foreigner
  • •no agree a concent

研究组 & 干预措施

Anastomosis site stricture

Experimental

anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis

干预措施: deployment of through the scope covered metallic stent at the stricture site (Procedure)

Anastomosis site stricture

Experimental

anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis

干预措施: Covered Self-expandable Metallic Stents (Device)

结局指标

主要结局

Improvement of symptom (Resolving anastomosis site stricture)

时间窗: Up to 1 month

Improvement of food intake. It was measured by the gastric outlet obstruction scoring system (GOOSS) score, with 0 = no oral intake, 1 = liquid diet, 2 = soft diet, and 3 = regular diet.

次要结局

  • Complications associated with the procedure(Up to 1 month (time of stent removal))

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kee Myung Lee

Professor

Ajou University School of Medicine

研究点 (2)

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