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

Status unconfirmed

Conditions studied: Biliary Stricture, Pancreas Cancer, Cholangiocarcinoma, Bile Duct Cancer, Bile Duct Neoplasms Malignant, Bile Duct Neoplasms, Bile Duct Lesions, Bile Duct Obstruction, Bile Duct Diseases, Bile Duct Obstruction, Extrahepatic, Bile Duct Stenosi, Bile Duct Adenoma, Pancreatic Duct Stricture, Pancreatic Duct Stenosis, Pancreatic Duct Obstruction, Pancreatic Ductal Adenocarcinoma, Primary Sclerosing Cholangitis

In brief

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.

Key facts

Study ID

NCT03951324

Run by

Innovative Digestive Health Education and Research Inc

People needed

40

Starts

2019-05-10

Expected to finish

2019-12-31

Last updated by the study team

2019-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology -

Where it is running

• Innovative Digestive Health Education & Research Inc — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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