Skip to main content
OpenTrials
Completed

NCT Number: NCT02351492

Radiological Investigation of Bile Duct Obstruction

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecystectomy and intraoperative cholangiography

Procedure

Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.

Other names: IOC

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.

Other names: MRCP

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.

Other names: MRI

catheter

Device

Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.

Primary outcomes

  1. Length of Hospital stay

    Time frame: 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 outcomes

  1. Costs of Hospital stay

    Time frame: days in hospital assessed at hospital discharge day, on average 8 days

    Computed by the financial departments of each involved hospital

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

Registry information

Official study title

Diagnostic Pathway for Surgical Patients With Suspected Bile Duct Obstruction

Acronym: RIBO

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2015
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.