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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
Sponsor:
Collaborators:
Alberta Heritage Foundation for Medical Research
American College of Gastroenterology
American Digestive Health Foundation
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Alan Barkun, McGill University Health Center

Tracking Information
First Submitted Date  ICMJE August 23, 2011
First Posted Date  ICMJE August 29, 2011
Last Update Posted Date August 29, 2011
Study Start Date  ICMJE October 1997
Actual 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 ]
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 No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Suspected Biliary Obstruction
Intervention  ICMJE
  • Procedure: ERCP
    Endoscopic retrograde cholangiopancreatography
  • Procedure: MRCP
    magnetic resonance cholangiopancreatography
Study Arms  ICMJE
  • 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 * Bhat M, Romagnuolo J, da Silveira E, Reinhold C, Valois E, Martel M, Barkun JS, Barkun AN. Randomised clinical trial: MRCP-first vs. ERCP-first approach in patients with suspected biliary obstruction due to bile duct stones. Aliment Pharmacol Ther. 2013 Nov;38(9):1045-53. doi: 10.1111/apt.12481. Epub 2013 Sep 11.

*   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
Actual Enrollment  ICMJE
 (submitted: August 26, 2011)
378
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2002
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01424657
Other Study ID Numbers  ICMJE REC. 97-026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alan Barkun, McGill University Health Center
Study Sponsor  ICMJE McGill University Health Center
Collaborators  ICMJE
  • Alberta Heritage Foundation for Medical Research
  • American College of Gastroenterology
  • American Digestive Health Foundation
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE Not Provided
PRS Account 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