Suspected Biliary Obstruction Clinical Trial
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.
| Status | Terminated |
| Enrollment | 378 |
| Est. completion date | July 2002 |
| Est. primary completion date | July 2002 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | MUHC- McGill University Health Center | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| McGill University Health Center | Alberta Heritage Foundation for Medical Research, American College of Gastroenterology, American Digestive Health Foundation, Canadian Institutes of Health Research (CIHR) |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | occurrence of adverse biliary events | 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 | 12 months | No |
| Secondary | complication-related length of stay | 12 months | Yes | |
| Secondary | Number of additional procedures (i.e ERCP, MRCP, US...) | 12 months | No | |
| Secondary | mortality | 12 months | No |