Laparoscopic Reinforcement Suture (LARS) on Staple-line of Duodenal Stump Using Barbed Suture in Laparoscopic Gastrectomy for Gastric Cancer: A Prospective Single Arm Phase II Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the incidence of duodenal stump fistula within postoperative 30 days
研究概览
简要总结
Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted.
We already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a prospective phase II study was designed for safety of this technique.
详细描述
As the results of recent prospective randomized controlled clinical trials, laparoscopic gastrectomy has been accepted by one of standard treatments for early gastric cancer in Korea, Japan and China.
However, duodenal stump leakage remains one of the fetal complications after gastrectomy until now. The incidence of duodenal stump leakage is reportedly between 1.6% to 5% in Billroth II or Roux en Y reconstruction after gastrectomy for gastric cancer. According to a recent multicenter study, the laparoscopic approach increased the risk of duodenal stump leakage development comparing to open approach.
Until now, no prospective clinical trial for duodenal stump leakage after laparoscopic or open gastrectomy for gastric cancer patients has been conducted. I already introduced a technique of laparoscopic reinforcement suture (LARS) on staple-line of duodenal stump using barbed suture for prevention of duodenal stump leakage. Therefore, a prospective phase II study was designed for safety of this technique.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven gastric adenocarcinoma that were treated with laparoscopic distal or total gastrectomy and B-II or Roux en Y reconstruction and age of above 19 years
排除标准
- •history of previous abdominal surgery except cholecystectomy and would be performed combined abdominal surgery except cholecystectomy. And also patients with advanced gastric cancer with gastric outlet obstruction or cancer invasion to pylorus
研究组 & 干预措施
Laparoscopic reinforcement suture
After cutting of duodenal stump of about 2 cm length using linear stapler, laparoscopic reinforcement suture commenced from upper to lower part on staple-line of duodenal stump. Continuous suture with invagination was performed using a barbed suture. In case of patient with short duodenal stump because of chronic ulcer or ectopic pancreas at duodenal bulb, 2 or 3 interrupted sutures without invagination of duodenal stump was conducted using barbed sutures.
干预措施: Laparoscopic reinforcement suture (Procedure)
结局指标
主要结局
the incidence of duodenal stump fistula within postoperative 30 days
时间窗: 30 days
Duodenal stump fistula was defined as clinical suspicion, laboratory finding of fluid from drain or radiologic finding such as CT scan or fistulogram.
次要结局
未报告次要终点
研究者
Kwan Woo Kim
Director
Dong-A University Hospital