Radiological Investigation of Bile Duct Obstruction

Gallstone Disease Clinical Trial

— RIBO  

Official title:

Diagnostic Pathway for Surgical Patients With Suspected Bile Duct Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351492
• Other study ID #: 221/13
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: January 2021

Study information

• Verified date: December 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Cholestasis
• Gallstone Disease
• Gallstones

Intervention

Procedure:
• Cholecystectomy and intraoperative cholangiography
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
• 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.

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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clinical Trial Unit, University Hospital Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	number of days patient spent in hospital assessed at discharge day, on average 8 days
Secondary	Costs of Hospital stay	Computed by the financial departments of each involved hospital	days in hospital assessed at hospital discharge day, on average 8 days