Cholangitis, Cholecystitis, Choledocholithiasis, Gallstone Migration, Gallstone Pancreatitis
Conditions
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.
Interventions
PROCEDURECholecystectomy with intraoperative cholangiogram
cf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution.
Sponsors
University Hospital, Geneva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital stay [days] | 1-100 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of common bile duct investigations [N] | 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 [%] | 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 | 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. |
Countries
Switzerland
Outcome results
None listed