Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion and Pancreatic Fistula After Pancreatoduodenectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Amount of pancreatic secretion
研究概览
简要总结
This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7 days. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure and amounted.
Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.
详细描述
This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide of 100ug(1mL) was injected subcutaneously just before operation and every 8 hours for 7 days postoperatively. The placebo group was managed with normal saline (1mL) for same period. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure (Barovac) and amounted.
Postoperative care of patients was same between groups such as pain control and supportive care. The amount of drained pancreatic juice via external stent was recorded everyday.
Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.
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
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will undergo pancreatoduodenectomy for periampullary tumors
排除标准
- •Patients with preoperative pancreatitis
- •Patients who did not undergo pancreatoduodenectomy
- •Patients who underwent bypass surgery or total pancreatectomy
- •Patients who injection of octreotide less than 5 days
研究组 & 干预措施
octreotide
After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days
干预措施: Octreotide (Drug)
Placebo
After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Amount of pancreatic secretion
时间窗: 1 day
次要结局
- Rate of pancreatic fistula(1 day)
研究者
YOU DONG DO
Associated Professor
Saint Vincent's Hospital, Korea