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Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease

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ClinicalTrials.gov Identifier: NCT01538368
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : February 24, 2012
Sponsor:
Information provided by (Responsible Party):
Till Wehrmann, Deutsche Klinik fuer Diagnostik

Brief Summary:
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.

Condition or disease
Suspected Bilio-pancreatic Disease

Study Type : Observational
Actual Enrollment : 155 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease: Should the Endoscopist Take a Second Look?
Study Start Date : January 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Endoscopic management [ Time Frame: 1 day ]
    Did the MRCP-interpretation by the gastroenterologist alter the scheduled endoscopic interventions ?


Secondary Outcome Measures :
  1. MRCP-interpretation [ Time Frame: 1 day ]
    Are there differences in the MRCP-interpreatation beween the radiologist and the gastroenterologist.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Responsible Party: Till Wehrmann, Head, Divison of Gastroenterology, DKD Wiesbaden, Deutsche Klinik fuer Diagnostik
ClinicalTrials.gov Identifier: NCT01538368     History of Changes
Other Study ID Numbers: TWehrmann
First Posted: February 24, 2012    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012

Keywords provided by Till Wehrmann, Deutsche Klinik fuer Diagnostik:
MRCP
ERCP
EUS
Image interpretation
MRCP findings
endoscopic intervention(s)

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases