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Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study (VLE-IOV)
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 |
|---|---|
| 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 |
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.
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 |
| Estimated 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 |
| Estimated Primary Completion Date : | December 31, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
| 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
|
- Interobserver agreement and diagnostic accuracy [ Time Frame: 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 [ Time Frame: 2 months ]Correlation analysis of any of the 9 visual criteria with malignancy diagnosis as determined by endoscopist
- 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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology -
Exclusion Criteria:
-
| United States, New Jersey | |
| Innovative Digestive Health Education & Research Inc | |
| New Brunswick, New Jersey, United States, 08901 | |
| Principal Investigator: | Michel Kahaleh, MD | Innovative Digestive Health Education and Research Inc |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | May 13, 2019 | ||||||
| First Posted Date | May 15, 2019 | ||||||
| Last Update Posted Date | August 12, 2019 | ||||||
| Actual Study Start Date | May 10, 2019 | ||||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
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.
|
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study | ||||||
| Official Title | Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study | ||||||
| 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. |
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| Detailed Description |
Objective: Validate diagnostic impact of VLE diagnostic accuracy on clinical management Primary Objectives:
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):
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 |
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| Study Type | Observational | ||||||
| Study Design | Observational Model: Other Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| 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. |
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| Condition |
|
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| Intervention | 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
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Enrolling by invitation | ||||||
| Estimated Enrollment |
40 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | December 31, 2019 | ||||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria: VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology - Exclusion Criteria: - |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03951324 | ||||||
| Other Study ID Numbers | 2565207-44318141 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Innovative Digestive Health Education and Research Inc | ||||||
| Study Sponsor | Innovative Digestive Health Education and Research Inc | ||||||
| Collaborators | NinePoint Medical | ||||||
| Investigators |
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| PRS Account | Innovative Digestive Health Education and Research Inc | ||||||
| Verification Date | August 2019 | ||||||
