Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
VLE-IOV
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2019
CompletedFirst Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedAugust 12, 2019
August 1, 2019
8 months
May 13, 2019
August 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Interobserver agreement and diagnostic accuracy
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
Correlation analysis of any of the 9 visual criteria with malignancy diagnosis as determined by endoscopist
2 months
Secondary Outcomes (1)
Number of procedures needed to view and conduct to use VLE for diagnostic confirmation
2 months
Study Arms (2)
Expert Endoscopists
Experienced Endoscopists with significant user experience with Volumetric Laser Endomicroscopy for bile duct/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
Interventions
Interobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures
Eligibility Criteria
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.
You may qualify if:
- VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Innovative Digestive Health Education & Research Inc
New Brunswick, New Jersey, 08901, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Kahaleh, MD
Innovative Digestive Health Education and Research Inc
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2019
First Posted
May 15, 2019
Study Start
May 10, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
August 12, 2019
Record last verified: 2019-08