NCT01424657

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
378

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 1997

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
Last Updated

August 29, 2011

Status Verified

August 1, 2011

Enrollment Period

4.8 years

First QC Date

August 23, 2011

Last Update Submit

August 26, 2011

Conditions

Suspected Biliary Obstruction

Keywords

MRCPERCPBILIARY OBSTRUCTIONEFFECTIVENESS

Outcome Measures

Primary Outcomes (1)

  • occurrence of adverse biliary events

    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

    12 months

Secondary Outcomes (3)

  • complication-related length of stay

    12 months

  • Number of additional procedures (i.e ERCP, MRCP, US...)

    12 months

  • mortality

    12 months

Study Arms (2)

ERCP

EXPERIMENTAL

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

MRCP

EXPERIMENTAL

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

Interventions

ERCPPROCEDURE

Endoscopic retrograde cholangiopancreatography

ERCP
MRCPPROCEDURE

magnetic resonance cholangiopancreatography

MRCP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUHC- McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 24024705DERIVED

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 29, 2011

Study Start

October 1, 1997

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

August 29, 2011

Record last verified: 2011-08

Locations

CA(1)