NCT01538368

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
Last Updated

February 24, 2012

Status Verified

February 1, 2012

Enrollment Period

2.9 years

First QC Date

February 20, 2012

Last Update Submit

February 23, 2012

Conditions

Suspected Bilio-pancreatic Disease

Keywords

MRCPERCPEUSImage interpretationMRCP findingsendoscopic intervention(s)

Outcome Measures

Primary Outcomes (1)

  • Endoscopic management

    Did the MRCP-interpretation by the gastroenterologist alter the scheduled endoscopic interventions ?

    1 day

Secondary Outcomes (1)

  • MRCP-interpretation

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who had any endoscopic interventions in our institution before and also patients who underwent MRCP at our hospital were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Divison of Gastroenterology, DKD Wiesbaden

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 24, 2012

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

February 24, 2012

Record last verified: 2012-02