- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2019-05-10
2019-12-31
2019-12-31
40
NCT03951324
Innovative Digestive Health Education and Research Inc
Innovative Digestive Health Education and Research Inc
OBSERVATIONAL
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
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-05-13 | N/A | 2019-08-09 |
2019-05-13 | N/A | 2019-08-12 |
2019-05-15 | N/A | 2019-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/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
|
| : 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of procedures needed to view and conduct to use VLE for diagnostic confirmation | Learning curve using CUSUM analysis to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management proficiently. | 2 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
