Efficacy of peri operative hydrocortisone treatment in reducing post operative complications after pancreatic resection - A Randomised Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Frequency of patients with postoperative complications occurring within 90 days after surgery.
研究概览
简要总结
Pancreatic resection carries a high morbidity of 30%–60% and a mortality of 5%. Several trials have been undertaken in the past decades to address this problem and reduce the incidence of pancreatic fistula as well as overall complication. Despite rigorous research, postoperative pancreatic fistula poses a significant challenge to surgeons given the fact that up to every third patient at high risk will develop a clinically significant pancreatic fistula after pancreatic surgery.
The greater morbidity seems to result from the systemic inflammatory response as pathophysiological reaction to tissue injury. Glucocorticoids are potent anti-inflammatory drugs that modulate expression of both inflammatory and anti inflammatory genes.There is limited but compelling evidence that peri-operative glucocorticosteroid can attenuate the inflammatory response, which in turn, can result in decreased post operative complications. Trials have shown the beneficial effect of corticosteroids in reducing morbidity and mortality of liver resection.There is paucity of data to show that glucocorticosteroids reduce the risk of major complications in high-risk pancreatic surgery patients. Only few foreign trials are done.
Hence this study is undertaken to study the efficacy of peri operative hydrocortisone treatment in reducing post operative complications after pancreatic resection by comparing with the placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective pancreatic resection for benign / malignant lesions ( Pancreaticoduodenecomty / Distal Pancreatectomy ± Splenectomy / Median Pancreatectomy )
- •Patients giving consent for trial.
排除标准
- •1.Patients < 18 years of age 2.Patients currently receiving systemic therapy with glucocorticoids for last 3 months 3.Patients with chronic pancreatitis 4.Patients with recent infection ( infection within 2 weeks) Cholangitis, Pneumonia, UTI.
结局指标
主要结局
Frequency of patients with postoperative complications occurring within 90 days after surgery.
时间窗: Within 90 days of surgery
次要结局
- Development of clinically significant Post operative pancreatic fistula(within 90 days of surgery)
- Development of Post operative Pancreatic Hemorrhage(within 90 days of surgery)
- Development of Delayed Gastric Emptying(within 90 days of surgery)
- Length of hospital stay(within 90 days of surgery)
- Ninety-day post operative mortality(within 90 days of surgery)