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Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study

United States40 participantsStarted 2019-05-10

Plain-language summary

The purpose of this study is to assess the interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria. This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology - Exclusion Criteria: \-

What they're measuring

Interobserver agreement and diagnostic accuracy

Timeframe: 2 months

Frequency and type of criteria visually identified on malignant VLE clips

Timeframe: 2 months

Trial details

NCT IDNCT03951324

SponsorInnovative Digestive Health Education and Research Inc

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Biliary Stricture trials