Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): Study Protocol for a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 4
- 主要终点
- Major complications (rates)
研究概览
简要总结
The goal of this clinical trial is to compare outcomes for interval or early laparoscopic cholecystectomy in patients with moderately severe and severe pancreatitis. The main question[s] it aims to answer are:
- To establish whether there is a difference in surgical outcomes comparing patients diagnosed with severe or moderately severe pancreatitis on which early cholecystectomy was performed versus performing interval cholecystectomy.
- The primary endpoint will be to evaluate major complications, defined as a Clavien-Dindo score greater than or equal to III/V.
- Secondary endpoints include evaluating minor complications (defined as a Clavien-Dindo score below III/V), biliary disease recurrence, mortality, postoperative hospital stay and postoperative admittance into an intensive care unit.
Participants will be randomly assigned to either group: early cholecystectomy during the pancreatitis hospitalization or interval cholecystectomy scheduled 4 weeks after clinical resolution of pancreatitis.
详细描述
CHISPA is a randomized controlled, parallel-group, superiority clinical trial. An intention- to-treat analysis will be performed. It seeks to evaluate differences between patients taken to early cholecystectomy during hospital admission (72 hours after randomization) versus delayed cholecystectomy (30 +/- 5 days after randomization). Primary endpoint is major complications associated to laparoscopic cholecystectomy defined as a Clavien-Dindo score of over III/V during the first 90 days after the procedure. Secondary endpoints include recurrence of biliary disease, mortality, minor complications (Clavien-Dindo score below III/V), days of postoperative hospital stay, and days admitted in an intensive care unit postoperatively.
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
- None
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
- •Age ≥18 years, diagnosis of pancreatitis according to Atlanta guidelines, moderately severe or severe pancreatitis (APACHE score ≥8 on admittance)
- •Biliary pancreatitis diagnosed on imaging (be it ultrasound, magnetic resonance imaging and/or tomography)
- •Recovery of pancreatitis by tolerance of oral intake (defined as 24 hours of food consumption of any consistency without emetic episodes and pain defined as 4/10 on the visual analogue score of pain) and written informed consent.
排除标准
- •Pregnancy
- •History of cholecystectomy
- •Planned open cholecystectomy
- •Pancreatitis-associated complication before laparoscopic cholecystectomy (compartment syndrome, bleeding and/or need for peripancreatic collection drainage)
- •Chronic pancreatitis,
- •More than one episode of pancreatitis
- •Active malignant disease
- •Septic shock
- •Choledocholithiasis not resolved by ERCP, post-ERCP perforation and post-ERCP concomitant pancreatitis.
结局指标
主要结局
Major complications (rates)
时间窗: 90 days
Clavien-Dindo score III in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
次要结局
- Minor complications (rates)(90 days)
- Recurrence (rates)(90 days)
- Mortality (rates)(90 days)
- Postoperative hospital stay length (days; median)(90 days)
- Postoperative stay length in the ICU (days; median)(90 days)
研究者
Camilo Ramirez Giraldo
General Surgeon
Hospital Universitario Mayor Méderi