Magnetic Resonance Cholangiopancreatography Versus Endoscopic Retrograde Cholangiopancreatography in the Approach to Patients With Suspected Biliary Obstruction
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- occurrence of adverse biliary events [ Time Frame: 12 months ] [ Designated as safety issue: No ]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
- complication-related length of stay [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Number of additional procedures (i.e ERCP, MRCP, US...) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 1997|
|Study Completion Date:||July 2002|
|Primary Completion Date:||July 2002 (Final data collection date for primary outcome measure)|
ERCP is an endoscopic examination that allows opacification of the biliary tree by direct injection into the common bile duct through its distal opening in the duodenum at the ampulla of Vater
Endoscopic retrograde cholangiopancreatography
The magnetic resonance cholangiopancreatography (MRCP)allows direct visualization of the biliary tree and pancreatic duct, similar to contrast cholangiography, but without the need for administration of contrast medium
magnetic resonance cholangiopancreatography
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424657
|MUHC- McGill University Health Center|
|Montreal, Quebec, Canada, H3G 1A4|