Phase Two Randomized Study of The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Postoperative delayed gastric emptying
研究概览
简要总结
A small gastric remnant after whipple resection improves gastric emptying and therefore prevents the development of delayed gastric emptying.
详细描述
Every patient submitted to a whipple resection and at the same time present with characteristics suggestive of minimal risk for leakage from the pancreaticojejunostomy will be included in the study. At the time of reconstruction the patient will be randomized to either conventional size of the stomach or to a subtotal gastrectomy containing a small upper gastric pouch only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing whipple procedure with preoperative assignment as low risk for leakage from the pancreaticojejunal anastomosis.
- •Signed informed consent.
排除标准
- •High and intermediate risk pancreaticojejunal anastomosis. Unwillingness to participate.
结局指标
主要结局
Postoperative delayed gastric emptying
时间窗: Postoperative recovery period in days (on an average <20 days)
During the postoperative phase the patient will be followed daily with assessment of symptoms suggestive of delayed gastric emptying.
次要结局
- Quality of life(during three first postoperative months)
- Postoperative hospital stay(In hospital stay in days (on an average <20 days))
- Total Gastric emptying as measured by the paracetamol test(three months postoperatively)
研究者
Lars Lundell
Professor
Karolinska University Hospital