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Radiological Investigation of Bile Duct Obstruction (RIBO)

Primary Purpose

Gallstone Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cholecystectomy and intraoperative cholangiography
Magnet resonance cholangio-pancreaticography
magnet resonance imaging
catheter
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gallstone Disease focused on measuring Bile duct obstruction, intraoperative cholangiography, MRCP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cholecystectomy and intraoperative cholangiography

Magnet resonance cholangio-pancreaticography

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Length of Hospital stay
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

Costs of Hospital stay
Computed by the financial departments of each involved hospital

Full Information

First Posted
January 7, 2015
Last Updated
December 6, 2022
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Clinical Trial Unit, University Hospital Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02351492
Brief Title
Radiological Investigation of Bile Duct Obstruction
Acronym
RIBO
Official Title
Diagnostic Pathway for Surgical Patients With Suspected Bile Duct Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Clinical Trial Unit, University Hospital Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallstone Disease
Keywords
Bile duct obstruction, intraoperative cholangiography, MRCP

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecystectomy and intraoperative cholangiography
Arm Type
Active Comparator
Arm Description
Patients with suspected bile duct obstruction intraoperative cholangiography (IOC) to investigate bile ducts.
Arm Title
Magnet resonance cholangio-pancreaticography
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cholecystectomy and intraoperative cholangiography
Other Intervention Name(s)
IOC
Intervention Description
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
Intervention Type
Procedure
Intervention Name(s)
Magnet resonance cholangio-pancreaticography
Other Intervention Name(s)
MRCP
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
magnet resonance imaging
Other Intervention Name(s)
MRI
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
catheter
Intervention Description
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
Primary Outcome Measure Information:
Title
Length of Hospital stay
Description
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.
Time Frame
number of days patient spent in hospital assessed at discharge day, on average 8 days
Secondary Outcome Measure Information:
Title
Costs of Hospital stay
Description
Computed by the financial departments of each involved hospital
Time Frame
days in hospital assessed at hospital discharge day, on average 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian A. Nebiker, MD, PD Dr.
Organizational Affiliation
Kantonsspital Aarau
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35817694
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.
Results Reference
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Radiological Investigation of Bile Duct Obstruction

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