Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Length of hospital stay [days]
研究概览
简要总结
Initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, has been implemented at the investigators institution as the standard management strategy for patients at intermediate risk of common bile duct stone migration, following a randomized controlled trial previously published by the same investigators team. The aim of this study is to prospectively analyze the outcomes of this strategy.
详细描述
A previous randomized controlled trial comparing initial cholecystectomy with intraoperative cholangiogram (IOC) versus common bile duct (CBD) assessment and subsequent cholecystectomy for patients admitted in the emergency room with an acute gallstone-related condition and with an intermediate risk of common bile duct stone was performed by the investigators. This study had been registered on Clinicaltrials.gov as well and had shown that a strategy with initial cholecystectomy significantly decreased the length of hospital stay and the number of CBD investigations procedures.
Initial cholecystectomy with IOC is now the standard management strategy for these patients in the investigators hospital. The goal of this study is to perform a prospective validation of this strategy and to analyze if the results obtained in the previously mentioned randomized controlled trial are confirmed on a larger patients cohort. This study will be observational, since the intervention (initial cholecystectomy) is not assigned by the investigators, but is already a standard treatment strategy at our institution.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission through emergency department for an acute gallstone-related condition (cholecystitis, gallstone pancreatitis, ascending cholangitis, suspicion of gallstone migration, choledocholithiasis)
排除标准
- •Severe sepsis or septic shock
- •contra-indication to surgery
- •previous surgery interfering with common bile duct assessment procedures (roux-en-y gastric bypass, etc.)
- •previous cholecystectomy
结局指标
主要结局
Length of hospital stay [days]
时间窗: 1-100 days
次要结局
- Common bile duct clearance rate [%](This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days)
- Morbidity(From admission up to 6 months after hospital discharge)
- Number of common bile duct investigations [N](Anytime during hospital stay, an expected average of 7 days)
研究者
Pouya Iranmanesh
MD
University Hospital, Geneva
