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
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
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
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
Kee Myung Lee
Professor
Ajou University School of Medicine
