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Radiological Investigation of Bile Duct Obstruction (RIBO)

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ClinicalTrials.gov Identifier: NCT02351492
Recruitment Status : Recruiting
First Posted : January 30, 2015
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gallstone Disease Procedure: Cholecystectomy and intraoperative cholangiography Procedure: Magnet resonance cholangio-pancreaticography Device: magnet resonance imaging Device: catheter Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Pathway for Surgical Patients With Suspected Bile Duct Obstruction
Study Start Date : May 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cholecystectomy and intraoperative cholangiography
Patients with suspected bile duct obstruction intraoperative cholangiography (IOC) to investigate bile ducts.
Procedure: Cholecystectomy and intraoperative cholangiography
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
Other Name: IOC

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

Active Comparator: 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.
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.
Other Name: MRCP

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.
Other Name: MRI




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351492


Contacts
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Contact: Christian A. Nebiker, MD, Dr. +41-(0)62 838 48 82 christian.nebiker@ksa.ch

Locations
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Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Christian A Nebiker, MD, Dr.         
Principal Investigator: Christian A Nebiker, MD, Dr.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
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Principal Investigator: Christian A. Nebiker, MD, PD Dr. Kantonsspital Aarau

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02351492     History of Changes
Other Study ID Numbers: 221/13
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Keywords provided by University Hospital, Basel, Switzerland:
Bile duct obstruction
intraoperative cholangiography
MRCP

Additional relevant MeSH terms:
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Gallstones
Cholestasis
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Bile Duct Diseases