Clinical trial NCT01424657: Magnetic Resonance Cholangiopancreatography Versus Endoscopic Retrograde Cholangiopancreatography in the Approach to Patients With Suspected Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Suspected Biliary Obstruction
Keywords: MRCP
ERCP
BILIARY OBSTRUCTION
EFFECTIVENESS
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Alberta Heritage Foundation for Medical Research
name: American College of Gastroenterology
name: American Digestive Health Foundation
name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-08-29
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the effectiveness and costs of magnetic resonance cholangiopancreatography (MRCP) and compare it to endoscopic retrograde cholangiopancreatography (ERCP) in the work up of patients with suspected bile duct obstruction on ultrasound. The investigators do not anticipate that a universal recommendation for a given diagnostic test (MRCP versus ERCP) will be applicable in all patients presenting with bile duct obstruction. Rather, the investigators hope to provide quantitative and comparative data relevant to the different clinical situations likely to be encountered in practice, in order to assist physicians in choosing the appropriate diagnostic modality. More specifically, the investigators feel that patients with intrahepatic or hilar obstruction (particularly those with malignant conditions), and those with partial common bile duct (CBD) obstruction (to rule out suspected choledocholithiasis) will benefit most from this new technology and the avoidance of an unnecessary ERCP to further determine the biliary anatomy.

Detailed description: The approach to investigation and management of intermediate-risk biliary obstruction is controversial. Both magnetic resonance cholangiopancreatography(MRCP)and endoscopic retrograde cholangiopancreatography (ERCP) are used interchangeably in practice, with little literature to support the efficacy of one versus the other.

The purpose is to assess the effectiveness of MRCP compared to ERCP in the initial work-up of patients at intermediate risk of suspected biliary obstruction following initial clinical assessment and ultrasonography.

A randomized medical effectiveness study was conducted across three tertiary care hospital sites. Patients at intermediate risk of biliary obstruction were randomized to either ERCP or MRCP based on level of obstruction as seen by ultrasound (US).

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Elevated bilirubin (\>30 umol/L)
* CBD dilatation on ultrasound: greater than 7 mm wide with gallbladder in situ, or 10mm wide in patient post-cholecystectomy
* Suspected or detected gallstone on ultrasound

Exclusion Criteria:

* Low probability of biliary tract disease
* Active cholangitis
* Bilio-pancreatic pathology identified on ultrasound or CT scan
* Any clinical condition precluding MRCP or ERCP: severe cardio-respiratory disease, pregnancy, significant coagulopathy (INR over 1.5)
* Presence of Roux-en-Y bilio-enteric anastomosis
* Any metallic implant making ERCP or MRCP hazardous
* ERCP or MRCP performed within 6 months prior to study inclusion

Primary outcomes:
measure: occurrence of adverse biliary events
timeFrame: 12 months
Secondary outcomes:
measure: complication-related length of stay
timeFrame: 12 months
measure: Number of additional procedures (i.e ERCP, MRCP, US...)
timeFrame: 12 months
measure: mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC- McGill University Health Center
state: Quebec
Study officials:
References:
citation: Bhat M, Romagnuolo J, da Silveira E, Reinhold C, Valois E, Martel M, Barkun JS, Barkun AN. Randomised clinical trial: MRCP-first vs. ERCP-first approach in patients with suspected biliary obstruction due to bile duct stones. Aliment Pharmacol Ther. 2013 Nov;38(9):1045-53. doi: 10.1111/apt.12481. Epub 2013 Sep 11.