An interventional study of Cholecystectomy and intraoperative cholangiography and Magnet resonance cholangio-pancreaticography in Gallstone Disease, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-08.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic
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.
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
346 studies on the registry are indexed under Gallstones; 46 are open to participants now.
This study's enrollment of 122 is above the median of 99 across 232 interventional studies indexed under Gallstones.
Browse Gallstones studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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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
Exclusion Criteria:
Patients with suspected bile duct obstruction intraoperative cholangiography (IOC) to investigate bile ducts.
Procedure: Cholecystectomy and intraoperative cholangiography · Device: catheter
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.
Procedure: Magnet resonance cholangio-pancreaticography · Device: magnet resonance imaging
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
Also known as: IOC
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.
Also known as: MRCP
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.
Also known as: MRI
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
Length of Hospital stay
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.
Time frame: number of days patient spent in hospital assessed at discharge day, on average 8 days
Costs of Hospital stay
Computed by the financial departments of each involved hospital
Time frame: days in hospital assessed at hospital discharge day, on average 8 days
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland