NCT02775227进行中（未招募）4 期
HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Comprehensive Complication Index
研究概览
简要总结
Pancreatic resections carry a high risk for complications, especially pancreatic fistula. Both hydrocortisone and pasireotide have been shown to be effective in reducing complications in earlier RCTs. The aim of this study is to compare the effectiveness and safety of these two drugs in preventing complications of pancreatic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for pancreatic surgery (pancreaticoduodenectomy, distal pancreatectomy, enucleation, or other type of pancreatic resection)
排除标准
- •Preoperative exclusion criteria:
- •Atrophic pancreas and/or dilated pancreatic duct at the site of planned pancreatic transsection (applies only to patients undergoing pancreaticoduodenectomy)
- •Total pancreatectomy planned
- •Allergy or other contraindication for hydrocortisone or pasireotide
- •Age < 18 years
- •No informed consent
- •Intraoperative exclusion criteria:
- •Pancreatic resection cancelled (e.g. disseminated cancer)
- •Hard pancreas and/or dilated pancreatic duct discovered during operation (applies only to patients undergoing pancreaticoduodenectomy)
- •Total pancreatectomy is performed
研究组 & 干预措施
Hydrocortisone
Experimental
干预措施: Hydrocortisone (Drug)
Pasireotide
Active Comparator
干预措施: Pasireotide (Drug)
结局指标
主要结局
Comprehensive Complication Index
时间窗: 30 days postoperatively
次要结局
- Complications (Clavien-Dindo classification)(30 days postoperatively)
- Postoperative pancreatic fistula (ISGPS-classification)(30 days postoperatively)
- Postoperative delayed gastric emptying (ISGPS-classification)(30 days postoperatively)
- Post-pancreatectomy hemorrhage (ISGPS-classification)(30 days postoperatively)
- Length of hospital stay, days(During hospital stay, on average 7-14 days)
- Readmissions(30 days postoperatively)
研究者
Ville Sallinen
MD, PhD
Helsinki University Central Hospital
研究点 (1)
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