Radiological Investigation of Bile Duct Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2021-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Gallstone Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cholecystectomy and intraoperative cholangiography

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

Group Type ACTIVE_COMPARATOR

Cholecystectomy and intraoperative cholangiography

Intervention Type PROCEDURE

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

catheter

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Magnet resonance cholangio-pancreaticography

Intervention Type 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.

magnet resonance imaging

Intervention Type 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.

Interventions

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Cholecystectomy and intraoperative cholangiography

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

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

catheter

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

Intervention Type DEVICE

Other Intervention Names

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IOC MRCP MRI

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No