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
  Purpose

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.


Condition Intervention Phase
Suspected Biliary Obstruction
Procedure: ERCP
Procedure: MRCP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 378
Study Start Date: October 1997
Study Completion Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: ERCP
Endoscopic retrograde cholangiopancreatography
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
Procedure: MRCP
magnetic resonance cholangiopancreatography

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424657

Locations
Canada, Quebec
MUHC- McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Center
Alberta Heritage Foundation for Medical Research (AHFMR)
American College of Gastroenterology
American Digestive Health Foundation
Canadian Institute for Health Research (CIHR)
  More Information

No publications provided by McGill University Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alan Barkun, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01424657     History of Changes
Other Study ID Numbers: REC. 97-026
Study First Received: August 23, 2011
Last Updated: August 26, 2011
Health Authority: United States: Food and Drug Administration
Canada: MUHC Research Ethics Board

Keywords provided by McGill University Health Center:
MRCP
ERCP
BILIARY OBSTRUCTION
EFFECTIVENESS

ClinicalTrials.gov processed this record on August 26, 2014