Prospective Validation of “Cholecystectomy First” Strategy for Gallstone Migration

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 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

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