Suspected Biliary ObstructionPhase 3NCT01424657
Magnetic Resonance Cholangiopancreatography Versus Endoscopic Retrograde Cholangiopancreatography in the Approach to Patients With Suspected Biliary Obstruction
A Phase 3 study testing ERCP and MRCP in people with Suspected Biliary Obstruction, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected Biliary Obstruction
- What is being tested?
- ERCP and MRCP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteCanada
- Study dates
- Oct 1997to Jul 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Suspected Biliary Obstruction
- Being tested
- ERCP, MRCP
- Keywords
- MRCP, ERCP, BILIARY OBSTRUCTION, EFFECTIVENESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Endoscopic retrograde cholangiopancreatography
MRCPProcedure or surgery
magnetic resonance cholangiopancreatography
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: MRCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
complication-related length of stay
Measured: 12 months
Number of additional procedures (i.e ERCP, MRCP, US...)
Measured: 12 months
mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startOct 1997
- Primary completionJul 2002
- Study completionJul 2002
Why it stopped: The study was terminated before reaching the estimated sample size because of trial fatigue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suspected Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, American College of Gastroenterology, American Digestive Health Foundation, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424657
- Sponsor's protocol ID
- REC. 97-026
- Status last verified
- Aug 2011
- First submitted
- 23 Aug 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24024705
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Cholangiopancreatography Versus Endoscopic Retrograde Cholangiopancreatography in the Approach to Patients With Suspected Biliary Obstruction
- ClinicalTrials.gov ID
- NCT01424657
- Acronym / sponsor ID
- REC. 97-026
- Conditions
- Suspected Biliary Obstruction
- Keywords
- MRCP, ERCP, BILIARY OBSTRUCTION, EFFECTIVENESS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated before reaching the estimated sample size because of trial fatigue.
- Enrolment
- 378 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Alberta Heritage Foundation for Medical Research, American College of Gastroenterology, American Digestive Health Foundation, Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 1997
- Primary completion
- Jul 2002 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP | Experimental | Procedure: ERCPERCP 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 | Experimental | Procedure: MRCPThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCPEndoscopic retrograde cholangiopancreatography | Procedure or surgery | ERCP |
| MRCPmagnetic resonance cholangiopancreatography | Procedure or surgery | MRCP |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: The study was terminated before reaching the estimated sample size because of trial fatigue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
- Derived from this study: PubMed 24024705Bhat 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ERCP and MRCP in people with Suspected Biliary Obstruction, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated before reaching the estimated sample size because of trial fatigue.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of adverse biliary events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01424657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2011.