Magnetic Resonance Cholangiopancreatography Versus Endoscopic Retrograde Cholangiopancreatography in the Approach to Patients With Suspected Biliary Obstruction

This study has been terminated.

(The study was terminated before reaching the estimated sample size because of trial fatigue.)

Sponsor:

Collaborators:

Alberta Heritage Foundation for Medical Research (AHFMR)

American College of Gastroenterology

American Digestive Health Foundation

Canadian Institute for Health Research (CIHR)

Information provided by (Responsible Party):

Alan Barkun, McGill University Health Center

ClinicalTrials.gov Identifier:

NCT01424657

First received: August 23, 2011

Last updated: August 26, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 23, 2011
Last Updated Date	August 26, 2011
Start Date ^ICMJE	October 1997
Primary Completion Date	July 2002 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 26, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01424657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 26, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Magnetic Resonance Cholangiopancreatography Versus Endoscopic Retrograde Cholangiopancreatography in the Approach to Patients With Suspected Biliary Obstruction
Official Title ^ICMJE	Not Provided
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).
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Suspected Biliary Obstruction
Intervention ^ICMJE	Procedure: ERCP Endoscopic retrograde cholangiopancreatography Procedure: MRCP magnetic resonance cholangiopancreatography
Study Arm (s)	Experimental: ERCP 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 Intervention: Procedure: ERCP Experimental: MRCP 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 Intervention: Procedure: MRCP
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	378
Completion Date	July 2002
Primary Completion Date	July 2002 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01424657
Other Study ID Numbers ^ICMJE	REC. 97-026
Has Data Monitoring Committee	No
Responsible Party	Alan Barkun, McGill University Health Center
Study Sponsor ^ICMJE	McGill University Health Center
Collaborators ^ICMJE	Alberta Heritage Foundation for Medical Research (AHFMR) American College of Gastroenterology American Digestive Health Foundation Canadian Institute for Health Research (CIHR)
Investigators ^ICMJE	Not Provided
Information Provided By	McGill University Health Center
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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