Randomized Controlled Trial on Role of Octreotide in Preventing Pancreatic Fistula and Complications After Pancreaticoduodenectomy in Patients With Soft Pancreas
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Pancreatic fistula
研究概览
简要总结
This randomized controlled trial (RCT) aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas. Previously reported trials have included all types of pancreatic resections and have include all types of pancreas and have shown no clearcut benefit of octreotide after pancreaticoduodenectomy (PD). Soft pancreas and normal sized duct are the risk factors for fistula following PD. This study's focus is on this select group of patients and aims to assess the role of octreotide in patients with soft pancreas.
详细描述
Study design: Prospective open labeled randomized trial. AIM: Study aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective surgery patients undergoing pancreatoduodenectomy
- •soft pancreas, no dilated duct
排除标准
- •age > 75 years old
- •documented chronic pancreatitis
- •previous pancreatic surgery
- •previous gastric surgery vagotomy
- •documented pancreatic duct dilatation
研究组 & 干预措施
octreotide
octreotide arm 100mcg for 5 days. control has no octreotide
干预措施: Inj. Octreotide (Drug)
结局指标
主要结局
Pancreatic fistula
时间窗: 30 days
All grades of postoperative pancreatic fistula as per ISGPF definition
次要结局
- complications(30 days)
研究者
Dr Prakash K
Chief GI Surgeon
PVS Memorial Hospital