Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
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.
Objective: Validate diagnostic impact of VLE diagnostic accuracy on clinical management

 Primary Objectives:

 1. Interobserver study for criteria validation and accuracy, Positive predictive value
 (PPV) and Negative predictive value (NPV), sensitivity and specificity.

 2. Evaluation of VLE diagnostics on clinical management (increased accuracy/faster
 detection)

 3. Determination of learning curve to standardize credentialing for endoscopists to use and
 interpret VLE imaging for biliary/pancreatic treatment management.

 B. Hypotheses / Research Question(s) The new VLE criteria for biliary and pancreatic duct
 strictures increase accuracy, thus leading to substantial impact on clinical management
 (Screening and Treatment)

 Study Design (2 phase):

 -  Phase 1: Primary Objective 1 and 2 part of the study will be completed.

 -  Phase 2: Primary Objective 3 of the study will be conducted within 1 month.

 Study Timeline: 3 months post WIRB approval. Sample size: 40 VLE Clips of at least 20 seconds
 featuring one or more the VLE criteria. All clips will have confirmed diagnosis for accuracy
 analysis. All clips will be de-identified. All clips will be removed from RedCAP and other
 secure cloud storage upon completion of study.

 Clips will be supplied by NinePoint Medical, the company behind VLE OCT. All VLE clips will
 be from a dataset of clips collected from adults > 18 and who underwent Endoscopic retrograde
 cholangiopancreatography (ERCP) with indeterminate biliary stricture indications. The clips
 are chosen based on the quality of the clips, duration, final diagnosis and presence of
 either benign or malignant criteria.

 Investigators: Up to 30 Expert and non-expert endoscopists currently using VLE
Inclusion Criteria:

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

 Exclusion Criteria:

 -