Magnetic Resonance Cholangiopancreatography Versus Endoscopic Retrograde Cholangiopancreatography in the Approach to Patients With Suspected Biliary Obstruction
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|ClinicalTrials.gov Identifier: NCT01424657|
Recruitment Status : Terminated (The study was terminated before reaching the estimated sample size because of trial fatigue.)
First Posted : August 29, 2011
Last Update Posted : August 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Suspected Biliary Obstruction||Procedure: ERCP Procedure: MRCP||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||378 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 1997|
|Actual Primary Completion Date :||July 2002|
|Actual Study Completion Date :||July 2002|
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
- occurrence of adverse biliary events [ Time Frame: 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
- complication-related length of stay [ Time Frame: 12 months ]
- Number of additional procedures (i.e ERCP, MRCP, US...) [ Time Frame: 12 months ]
- mortality [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424657
|MUHC- McGill University Health Center|
|Montreal, Quebec, Canada, H3G 1A4|