Radiological Investigation of Bile Duct Obstruction

Study Overview
=================
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

Official Title
-----------------
Diagnostic Pathway for Surgical Patients With Suspected Bile Duct Obstruction

Conditions
-----------------
Gallstone Disease

Intervention / Treatment
-----------------
* Procedure: Cholecystectomy and intraoperative cholangiography
* Procedure: Magnet resonance cholangio-pancreaticography
* Device: magnet resonance imaging
* Device: catheter


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cholecystectomy and intraoperative cholangiography<br>Patients with suspected bile duct obstruction intraoperative cholangiography (IOC) to investigate bile ducts. | Procedure: Cholecystectomy and intraoperative cholangiography<br>* Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.<br>* Other names: IOC;Device: catheter<br>* Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.<br>|
| Active Comparator: Magnet resonance cholangio-pancreaticography<br>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<br>* 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.<br>* Other names: MRCP;Device: magnet resonance imaging<br>* 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.<br>* Other names: MRI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bile duct obstruction, intraoperative cholangiography, MRCP