Suspected Biliary Obstruction
Conditions
Keywords
MRCP, ERCP, BILIARY OBSTRUCTION, EFFECTIVENESS
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).
Interventions
PROCEDUREERCP
Endoscopic retrograde cholangiopancreatography
PROCEDUREMRCP
magnetic resonance cholangiopancreatography
Sponsors
Alberta Heritage Foundation for Medical Research
American College of Gastroenterology
American Digestive Health Foundation
Canadian Institutes of Health Research (CIHR)
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of adverse biliary events | 12 months | The goal of this study was to evaluate the effectiveness of MRCP compared to ERCP in assessment of patients at intermediate risk for suspected biliary obstruction |
Secondary
| Measure | Time frame |
|---|---|
| complication-related length of stay | 12 months |
| Number of additional procedures (i.e ERCP, MRCP, US...) | 12 months |
| mortality | 12 months |
Countries
Canada
Outcome results
None listed