Gallstone Disease
Conditions
Keywords
Bile duct obstruction, intraoperative cholangiography, MRCP
Brief summary
Patients with gallstone disease should be checked whether a common bile duct (CBD) stone could be present. In case of a certain suspicion for CBD stones further investigations should be performed. This can either be done by magnetic resonance cholangio-pancreaticography (MRCP) or by intraoperative cholangiography. The study investigates which pathway would be favorable in regard of an early hospital demission.
Detailed description
Patients with gallstone disease and suspected bile duct obstruction can be investigated either with a magnetic resonance cholangio-pancreaticography (MRCP) prior to gallbladder removal or with an intraoperative cholangiography during cholecystectomy. When detecting an common bile duct (CBD) stone in MRCP, normally endoscopic removal is performed before an operation. When the CBD stone is detected during gallbladder removal instead, endoscopic retrograde cannulation of the pancreatic duct (ERCP) will follow after the operation. Investigators hypothesize that direct operation shortens the length of hospital stay. Therefore investigators randomize patients with elevated Bilirubin, elevated liver enzymes (two of the following: aspartate transaminase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (gGT) or AP), suspected CBD stones in ultrasound or dilated common bile ducts either in MRCP first or operation first pathway. All data (patient admission to discharge, ...) will be entered in an online database
Interventions
PROCEDURECholecystectomy and intraoperative cholangiography
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
PROCEDUREMagnet resonance cholangio-pancreaticography
Patients get Magnet resonance cholangio-pancreaticography MRCP first. In case of detected gallstones, removal of the stones by endoscopic retrograde cholangiopancreaticography will be performed before gallbladder removal.
DEVICEmagnet resonance imaging
Patients get Magnet resonance cholangio-pancreaticography MRCP first. In case of detected gallstones, removal of the stones by endoscopic retrograde cholangiopancreaticography will be performed before gallbladder removal.
DEVICEcatheter
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
Sponsors
Clinical Trial Unit, University Hospital Basel, Switzerland
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients presenting as regular admission or at the emergency department (ED) with cholecystolithiasis and suspected CBD stones. The indication for CBD investigation requires one of the following features: i. Elevated bilirubin ii. ASAT/ALAT or gGT or aP above the normal range (two of them) iii. Choledocholithiasis in ultrasound iv. Dilated bile ducts in ultrasound * Written informed consent
Exclusion criteria
* Age under 18 years * Patients with biliary pancreatitis (due to the fact that conservative treatment is initiated before gallbladder removal and therefore leads to a prolonged hospital stay) * Septic patients due to cholangitis * Patients unable to consent * Patients with medical conditions preventing surgery * Pregnancy * Radiologically proven CBD stone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital stay | number of days patient spent in hospital assessed at discharge day, on average 8 days | Time of hospital entry to time of patient dischargeable, according to stuff surgeon. Dates will be entered in an online database, which is also used for randomisation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Costs of Hospital stay | days in hospital assessed at hospital discharge day, on average 8 days | Computed by the financial departments of each involved hospital |
Countries
Switzerland
Outcome results
None listed