- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01538368
Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease
February 23, 2012 updated by: Till Wehrmann, Deutsche Klinik fuer Diagnostik
Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease: Should the Endoscopist Take a Second Look?
The interpretation of Magnetic Resonance Cholangio-pancreatography (MRCP)-findings is primarily performed by radiologists who only in some cases have experience with the interpretation of endoscopic retrograde cholangiopancreatography (ERCP)-images.
It is unclear if MRCP-interpretation by the radiologist is sufficient to decide which additional endoscopic procedures might be necessary in an individual case or if an additional MRCP-interpretation by the endoscopist renders any clinical impact.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
155
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
During 1/2007 until 12/2009 consecutive patients who were referred for dedicated endoscopic procedures regarding suspected alterations of the pancreato-biliary ductal system (nearly exclusively for EUS and/or ERCP) to our unit based on actual MRCP-findings were enrolled.
Description
Inclusion Criteria:
- Patients aged 18 years or older who were referred for pancreato-biliary endoscopy to our unit based on actual MRCP-findings. In all cases MRCP should have been performed within 4 weeks prior admittance and a written radiological report as well as the digital images must be available.
Exclusion Criteria:
- Patients who had any endoscopic interventions in our institution before and also patients who underwent MRCP at our hospital were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endoscopic management
Time Frame: 1 day
|
Did the MRCP-interpretation by the gastroenterologist alter the scheduled endoscopic interventions ?
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRCP-interpretation
Time Frame: 1 day
|
Are there differences in the MRCP-interpreatation beween the radiologist and the gastroenterologist.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
February 20, 2012
First Submitted That Met QC Criteria
February 23, 2012
First Posted (Estimate)
February 24, 2012
Study Record Updates
Last Update Posted (Estimate)
February 24, 2012
Last Update Submitted That Met QC Criteria
February 23, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TWehrmann
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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