A Randomized Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 30-day hospital length of stay
研究概览
简要总结
Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis.
详细描述
The purpose of this study is to perform a single-center randomized trial to compare laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) within 24 hours of presentation versus after clinical resolution during index admission for mild gallstone pancreatitis on clinical and patient-reported outcomes. Additionally, this study aims to determine patients' values and preferences that influence decision-making regarding treatment options for gallstone pancreatitis. Hypothesis: During index admission for mild gallstone pancreatitis, early cholecystectomy within 24 hours of presentation regardless of symptoms or laboratory values versus after clinical resolution results in a shorter 30-day total hospital length of stay.
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
- •Diagnosis of gallstone pancreatitis. Patients will be considered to have gallstone pancreatitis if they have:
- •upper abdominal pain, nausea, vomiting, and epigastric tenderness
- •absence of ethanol abuse
- •elevated lipase level above the upper limit of normal (>370 U/L)
- •imaging confirmation of gallstones or sludge
- •Low predicted mortality using the Bedside Index of Severity in Acute Pancreatitis (BISAP) -Diagnosis of mild pancreatitis (i.e.,no evidence of organ failure or local or systemic complications)
- •Scheduled for laparoscopic cholecystectomy prior to discharge
- •Lack of any very strong indicator for choledocholithiasis based on the American Society for Gastrointestinal Endoscopy (ASGE) guidelines
- •Clinical stability as denoted by admission to a non-monitored floor bed.
排除标准
- •Pregnancy
- •Severe preexisting medical comorbidities precluding surgery, organ failure, local or systemic complications of acute pancreatitis
- •Chronic pancreatitis
- •Native language other than English and Spanish
- •Patient refusal to participate
结局指标
主要结局
30-day hospital length of stay
时间窗: 30 days
次要结局
- Initial hospital LOS(up to 30 days)
- Time from admission to cholecystectomy(up to 10 days)
- Number of participants who underwent conversion to open cholecystectomy(30 days)
- Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI)(baseline, 1 week)
- Change in patient reported outcomes as assessed by the Gastrointestinal Quality-of-Life Index (GIQLI) and Patients' Experience of Surgery Questionnaire (PESQ)(baseline, 6 weeks)
- Change in patient reported outcomes as assessed by the Patients' Experience of Surgery Questionnaire (PESQ)(baseline, 6 weeks)
- Change in health-related quality of life as assessed by the standard gamble(baseline, 6 weeks)
研究者
Lillian Kao
Professor
The University of Texas Health Science Center, Houston