NCT02351492

Radiological Investigation of Bile Duct Obstruction

Diagnostic Pathway for Surgical Patients With Suspected Bile Duct Obstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gallstone Disease

Interventions

Type	Name	Description
PROCEDURE	Cholecystectomy and intraoperative cholangiography	Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
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.
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.
DEVICE	catheter	Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.

Timeline

• Start date: 2015-05-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2015-01-30
• Last updated: 2022-12-08

Locations

1 site across 1 country: Switzerland