RIBO: Radiological Investigation of Bile Duct Obstruction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cholecystectomy and intraoperative cholangiography Patients with suspected bile duct obstruction intraoperative cholangiography (IOC) to investigate bile ducts. |
Procedure: Cholecystectomy and intraoperative cholangiography
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
Other Names:
Device: catheter
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
|
| Active Comparator: Magnet 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. |
Procedure: Magnet 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.
Other Names:
Device: magnet 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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:
- Elevated bilirubin ii. ASAT/ALAT or gGT or aP above the normal range (two of them)
- 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
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Patients unable to consent
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Patients with medical conditions preventing surgery
-
Pregnancy
-
Radiologically proven CBD stone
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Basel | Basel | Switzerland | 4031 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
- Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
- Principal Investigator: Christian A. Nebiker, MD, PD Dr., Kantonsspital Aarau
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 221/13