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

August 9, 2019 updated by: Innovative Digestive Health Education and Research Inc

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Innovative Digestive Health Education & Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Endoscopists who use VLE to diagnose indeterminate biliary or pancreatic duct strictures.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovative Digestive Health Education and Research Inc

Collaborators

NinePoint Medical

Investigators

  • Principal Investigator: Michel Kahaleh, MD, Innovative Digestive Health Education and Research Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2019

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (ACTUAL)

May 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2565207-44318141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholangiocarcinoma

Clinical Trials on Interobserver agreement or Interrater agreement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe