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Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration

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ClinicalTrials.gov Identifier: NCT02461147
Recruitment Status : Unknown
Verified June 2015 by Pouya Iranmanesh, University Hospital, Geneva.
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2015
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Pouya Iranmanesh, University Hospital, Geneva

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.

Condition or disease Intervention/treatment
Choledocholithiasis Gallstone Migration Cholecystitis Gallstone Pancreatitis Cholangitis Procedure: Cholecystectomy with intraoperative cholangiogram

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis
Study Start Date : September 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Validation cohort
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.
Procedure: Cholecystectomy with intraoperative cholangiogram
cf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution.




Primary Outcome Measures :
  1. Length of hospital stay [days] [ Time Frame: 1-100 days ]

Secondary Outcome Measures :
  1. Number of common bile duct investigations [N] [ Time Frame: Anytime during hospital stay, an expected average of 7 days ]
    These include number of endoscopic ultrasounds (EUS), magnetic cholangio-pancreatography (MRCP) and endoscopic retrograde cholangio-pancreatography (ERCP) performed during the patient's hospital stay

  2. Common bile duct clearance rate [%] [ Time Frame: This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days ]
    Percentage of patients where common bile duct (CBD) clearance was achieved after ERCP (did not require surgical exploration because of ERCP failure)

  3. Morbidity [ Time Frame: From admission up to 6 months after hospital discharge ]
    Morbidity will be assessed for each patient according to the Dindo-Clavien classification of surgical complications, including death.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted through the emergency department for an acute gallstone-related condition.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461147


Locations
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Switzerland
Geneva University Hospital
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Pouya Iranmanesh, MD Geneva University Hospital, Division of Digestive Surgery
Study Director: Christian Toso, MD-PhD Geneva University Hospital, Division of Digestive Surgery

Publications of Results:
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Responsible Party: Pouya Iranmanesh, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02461147     History of Changes
Other Study ID Numbers: CCK first validation
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Pancreatitis
Cholangitis
Cholecystitis
Gallstones
Cholelithiasis
Cholecystolithiasis
Choledocholithiasis
Pancreatic Diseases
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Common Bile Duct Diseases