Early versus delayed laparoscopic cholecystectomy in moderate and severe acute biliary pancreatitis: a randomised controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- A composite outcome of major pancreatic-biliary events from the
研究概览
简要总结
In patients with moderately severe and severe acute biliary
pancreatitis, the ideal timing of cholecystectomy which is the
definitive treatment to prevent further biliary complications is not
defined. Delaying cholecystectomy is associated with pancreatic-
biliary complications. In this study, we wish to define the ideal
timing of cholecystectomy in patients with moderate to severe acute
biliary pancreatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Moderately severe or severe biliary AP diagnosed as per revised Atlanta classification
- •Fit for surgery- A) anaesthetist the patient is fit for surgery B) Absence of large collection in right upper abdomen.
排除标准
- •1.Age < 18 years or >70 years 2.Prior history of hepatobiliary surgery 3.American Society of Anesthesiology class III or more 4.Significant co-morbidity such as chronic kidney disease (CKD-V), Decompensated cirrhosis or congestive heart failure 6.Pregnancy 7.Refusal to give consen.
结局指标
主要结局
A composite outcome of major pancreatic-biliary events from the
时间窗: Time of pancreatitis to time of surgery | 1 week post surgery | 3 week post surgery | 3 month post surgery
time of randomization to surgery or major cholecystectomy
时间窗: Time of pancreatitis to time of surgery | 1 week post surgery | 3 week post surgery | 3 month post surgery
related complications i. e.
时间窗: Time of pancreatitis to time of surgery | 1 week post surgery | 3 week post surgery | 3 month post surgery
A. By comparing the recurrence of acute pancreatitis, cholangitis,
时间窗: Time of pancreatitis to time of surgery | 1 week post surgery | 3 week post surgery | 3 month post surgery
cholecystitis or
时间窗: Time of pancreatitis to time of surgery | 1 week post surgery | 3 week post surgery | 3 month post surgery
conversion of laparoscopic to open procedure, hollow viscus
时间窗: Time of pancreatitis to time of surgery | 1 week post surgery | 3 week post surgery | 3 month post surgery
injury, biliary injury or vascular injury
时间窗: Time of pancreatitis to time of surgery | 1 week post surgery | 3 week post surgery | 3 month post surgery
other pancreatic-biliary events requiring any invasive intervention.
时间窗: Time of pancreatitis to time of surgery | 1 week post surgery | 3 week post surgery | 3 month post surgery
B. By comparing the major surgical complications like
时间窗: Time of pancreatitis to time of surgery | 1 week post surgery | 3 week post surgery | 3 month post surgery
次要结局
- - Minor Surgical Complications(➢ Need for drainage procedure for peripancreatic fluid collection)