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.
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
Enrollment
161
cf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution.
Geneva University Hospital
Geneva, Switzerland
Length of hospital stay [days]
Time frame: 1-100 days
Number of common bile duct investigations [N]
These include number of endoscopic ultrasounds (EUS), magnetic cholangio-pancreatography (MRCP) and endoscopic retrograde cholangio-pancreatography (ERCP) performed during the patient's hospital stay
Time frame: Anytime during hospital stay, an expected average of 7 days
Common bile duct clearance rate [%]
Percentage of patients where common bile duct (CBD) clearance was achieved after ERCP (did not require surgical exploration because of ERCP failure)
Time frame: This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days
Morbidity
Morbidity will be assessed for each patient according to the Dindo-Clavien classification of surgical complications, including death.
Time frame: From admission up to 6 months after hospital discharge
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