Clinical trial NCT02351492: Radiological Investigation of Bile Duct Obstruction
Official title: Diagnostic Pathway for Surgical Patients With Suspected Bile Duct Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallstone Disease
Keywords: Bile duct obstruction
intraoperative cholangiography
MRCP
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
First posted: 2015-01-30
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility 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:

  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

Primary outcomes:
measure: Length of Hospital stay
timeFrame: number of days patient spent in hospital assessed at discharge day, on average 8 days
Secondary outcomes:
measure: Costs of Hospital stay
timeFrame: days in hospital assessed at hospital discharge day, on average 8 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Kantonsspital Aarau
name: Christian A. Nebiker, MD, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.