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
|Condition or disease||Intervention/treatment|
|Choledocholithiasis Gallstone Migration Cholecystitis Gallstone Pancreatitis Cholangitis||Procedure: Cholecystectomy with intraoperative cholangiogram|
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|
|Estimated Enrollment :||500 participants|
|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|
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.
- Length of hospital stay [days] [ Time Frame: 1-100 days ]
- 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
- 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)
- 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.
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
|Geneva University Hospital|
|Geneva, Switzerland, 1205|
|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|