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

• Conditions: Cholangiocarcinoma; Pancreatic Ductal Adenocarcinoma; Primary Sclerosing Cholangitis; Biliary Stricture; Bile Duct Neoplasms Malignant; Pancreas Cancer; Bile Duct Cancer; Bile Duct Neoplasms; Bile Duct Obstruction, Extrahepatic; Bile Duct Adenoma
• Interventions: Other: Interobserver agreement or Interrater agreement

• Registration Number: NCT03951324
• Lead Sponsor: Innovative Digestive Health Education and Research Inc

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2019-05-10
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-12
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Expert Endoscopists	Interobserver agreement or Interrater agreement	Experienced Endoscopists with significant user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures
None-Expert Endoscopists	Interobserver agreement or Interrater agreement	Experienced Endoscopists with non-significant or beignner user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures

Primary Outcome Measures

Name	Time	Method
Interobserver agreement and diagnostic accuracy	2 months	Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity
Frequency and type of criteria visually identified on malignant VLE clips	2 months	Correlation analysis of any of the 9 visual criteria with malignancy diagnosis as determined by endoscopist

Secondary Outcome Measures

Name	Time	Method
Number of procedures needed to view and conduct to use VLE for diagnostic confirmation	2 months	Learning curve using CUSUM analysis to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management proficiently.

Trial Locations

Locations (1)

Innovative Digestive Health Education & Research Inc; 🇺🇸 New Brunswick, New Jersey, United States