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

Phase 3

Terminated

• Conditions: Suspected Biliary Obstruction
• Interventions: Procedure: ERCP; Procedure: MRCP

• Registration Number: NCT01424657
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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 Timeline

• Study Start: 1997-10
• Primary Completion: 2002-07
• Study Completion: 2002-07
• Status Verified: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-26
• Last Update Submitted: 2011-08-26
• Study First Posted: 2011-08-29
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 378

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERCP	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
MRCP	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

Primary Outcome Measures

Name	Time	Method
occurrence of adverse biliary events	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

Secondary Outcome Measures

Name	Time	Method
complication-related length of stay	12 months
Number of additional procedures (i.e ERCP, MRCP, US...)	12 months
mortality	12 months

Trial Locations

Locations (1)

MUHC- McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada