Radiological Investigation of Bile Duct Obstruction (RIBO)

University Hospital Basel

Status: Completed

Conditions: Gallstone Disease

Treatments: Procedure: Magnet resonance cholangio-pancreaticography; Device: catheter; Procedure: Cholecystectomy and intraoperative cholangiography; Device: magnet resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02351492

221/13

Details and patient eligibility

About

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.

Full 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

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Cholecystectomy and intraoperative cholangiography

Active Comparator group

Description:

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

Treatment:

Procedure: Cholecystectomy and intraoperative cholangiography

Device: catheter

Magnet resonance cholangio-pancreaticography

Active Comparator group

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.

Treatment:

Device: magnet resonance imaging

Procedure: Magnet resonance cholangio-pancreaticography