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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Till Wehrmann, Deutsche Klinik fuer Diagnostik
ClinicalTrials.gov Identifier:
NCT01538368
First received: February 20, 2012
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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
Suspected Bilio-pancreatic Disease

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Deutsche Klinik fuer Diagnostik:

Primary Outcome Measures:
  • Endoscopic management [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Did the MRCP-interpretation by the gastroenterologist alter the scheduled endoscopic interventions ?


Secondary Outcome Measures:
  • MRCP-interpretation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Are there differences in the MRCP-interpreatation beween the radiologist and the gastroenterologist.


Enrollment: 155
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: February 20, 2012
Last Updated: February 23, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014