Brief Title
Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
Official Title
Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis
Brief Summary
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.
Detailed Description
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.
Study Type
Observational
Primary Outcome
Length of hospital stay [days]
Secondary Outcome
Number of common bile duct investigations [N]
Condition
Choledocholithiasis
Intervention
Cholecystectomy with intraoperative cholangiogram
Study Arms / Comparison Groups
Validation cohort
Description: All patients of the study (single group, single arm) will undergo initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, according to the standard protocol of treatment previously implemented at the investigators institution.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
161
Start Date
September 2013
Completion Date
June 2016
Primary Completion Date
January 2016
Eligibility Criteria
Inclusion Criteria: - Admission through emergency department for an acute gallstone-related condition (cholecystitis, gallstone pancreatitis, ascending cholangitis, suspicion of gallstone migration, choledocholithiasis) Exclusion Criteria: - 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
Gender
All
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pouya Iranmanesh, MD, ,
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT02461147
Organization ID
CCK first validation
Responsible Party
Principal Investigator
Study Sponsor
University Hospital, Geneva
Study Sponsor
Pouya Iranmanesh, MD, Principal Investigator, Geneva University Hospital, Division of Digestive Surgery
Verification Date
November 2020