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

Suspected Bilio-pancreatic Disease Clinical Trial

Official title:

Magnetic Resonance Cholangio-pancreatography (MRCP) for Suspected Bilio-pancreatic Disease: Should the Endoscopist Take a Second Look?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538368
• Other study ID #: TWehrmann
• Status: Completed
• Phase: N/A
• First received: February 20, 2012
• Last updated: February 23, 2012
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2012
• Source: Deutsche Klinik fuer Diagnostik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatic Diseases
• Suspected Bilio-pancreatic Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Deutsche Klinik fuer Diagnostik

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic management	Did the MRCP-interpretation by the gastroenterologist alter the scheduled endoscopic interventions ?	1 day	No
Secondary	MRCP-interpretation	Are there differences in the MRCP-interpreatation beween the radiologist and the gastroenterologist.	1 day	No