Radiological Investigation of Bile Duct Obstruction

Not Applicable

Completed

• Conditions: Gallstone Disease
• Interventions: Procedure: Magnet resonance cholangio-pancreaticography; Procedure: Cholecystectomy and intraoperative cholangiography; Device: catheter; Device: magnet resonance imaging

• Registration Number: NCT02351492
• Lead Sponsor: University Hospital, Basel, Switzerland

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

Study Timeline

• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-30
• Study Start: 2015-05
• Primary Completion: 2021-01
• Study Completion: 2021-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnet resonance cholangio-pancreaticography	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.
Cholecystectomy and intraoperative cholangiography	Cholecystectomy and intraoperative cholangiography	Patients with suspected bile duct obstruction intraoperative cholangiography (IOC) to investigate bile ducts.
Cholecystectomy and intraoperative cholangiography	catheter	Patients with suspected bile duct obstruction intraoperative cholangiography (IOC) to investigate bile ducts.
Magnet resonance cholangio-pancreaticography	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland