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| Name | Class |
|---|---|
| Clinical Trial Unit, University Hospital Basel, Switzerland | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecystectomy and intraoperative cholangiography | Active Comparator | Patients with suspected bile duct obstruction intraoperative cholangiography (IOC) to investigate bile ducts. |
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| Magnet resonance cholangio-pancreaticography | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecystectomy and intraoperative cholangiography | Procedure | Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | number of days patient spent in hospital assessed at discharge day, on average 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Costs of Hospital stay | Computed by the financial departments of each involved hospital | days in hospital assessed at hospital discharge day, on average 8 days |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Christian A. Nebiker, MD, PD Dr. | Kantonsspital Aarau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35817694 | Background | Staubli SM, Kettelhack C, Oertli D, von Holzen U, Zingg U, Mattiello D, Rosenberg R, Mechera R, Rosenblum I, Pfefferkorn U, Kollmar O, Nebiker CA. Efficacy of intraoperative cholangiography versus preoperative magnetic resonance cholangiography in patients with intermediate risk for common bile duct stones. HPB (Oxford). 2022 Nov;24(11):1898-1906. doi: 10.1016/j.hpb.2022.05.1346. Epub 2022 Jun 18. |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D001649 | Bile Duct Diseases |
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| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D057785 | Catheters |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D004864 | Equipment and Supplies |
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| Magnet resonance cholangio-pancreaticography | Procedure | 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. |
|
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| magnet resonance imaging | Device | 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. |
|
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| catheter | Device | Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts. |
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