Radiological Investigation of Bile Duct Obstruction

NCT02351492 | Completed

• 1 other identifier: 221/13
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallstone Disease

Keywords

Bile duct obstruction; intraoperative cholangiography; MRCP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Costs of Hospital stay

  days in hospital assessed at hospital discharge day, on average 8 days

Study Arms (2)

Cholecystectomy and intraoperative cholangiography

ACTIVE COMPARATOR

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

Procedure: Cholecystectomy and intraoperative cholangiography; Device: catheter

Magnet resonance cholangio-pancreaticography

ACTIVE COMPARATOR

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; Device: magnet resonance imaging

Interventions

Cholecystectomy and intraoperative cholangiography PROCEDURE

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

Also known as: IOC

Cholecystectomy and intraoperative cholangiography

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.

Also known as: MRCP

Magnet resonance cholangio-pancreaticography

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.

Also known as: MRI

Magnet resonance cholangio-pancreaticography

catheter DEVICE

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

Cholecystectomy and intraoperative cholangiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related 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.

  PMID: 35817694 BACKGROUND

MeSH Terms

Conditions

Cholelithiasis; Cholestasis

Interventions

Cholecystectomy; Catheters

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Equipment and Supplies

Study Officials

• Christian A. Nebiker, MD, PD Dr.

  Kantonsspital Aarau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 30, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

CH (1)