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

Sponsor

Innovative Digestive Health Education and Research Inc (Other)

Overall Status

Unknown status

CT.gov ID

NCT03951324

Collaborator

NinePoint Medical (Industry)

Enrollment

Location

7.7

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Interobserver agreement or Interrater agreement

Detailed Description

Objective: Validate diagnostic impact of VLE diagnostic accuracy on clinical management

Primary Objectives:

Interobserver study for criteria validation and accuracy, Positive predictive value (PPV) and Negative predictive value (NPV), sensitivity and specificity.
Evaluation of VLE diagnostics on clinical management (increased accuracy/faster detection)
Determination of learning curve to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management.

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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 10, 2019

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Expert Endoscopists Experienced Endoscopists with significant user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures	Other: Interobserver agreement or Interrater agreement Interobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures
None-Expert Endoscopists Experienced Endoscopists with non-significant or beignner user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures	Other: Interobserver agreement or Interrater agreement Interobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures

Arm

Intervention/Treatment

Expert Endoscopists

Experienced Endoscopists with significant user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures

Other: Interobserver agreement or Interrater agreement

Interobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures

None-Expert Endoscopists

Experienced Endoscopists with non-significant or beignner user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures

Other: Interobserver agreement or Interrater agreement

Interobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures

Outcome Measures

Primary Outcome Measures

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

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.