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临床试验/NCT02461147
NCT02461147已完成不适用

Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2013年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pouya Iranmanesh

MD

University Hospital, Geneva

研究点 (1)

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