Biliary StrictureVLE-IOVNCT03951324
Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
An observational study of Biliary Stricture and Pancreas Cancer, run by Innovative Digestive Health Education and Research Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stricture, Pancreas Cancer, Cholangiocarcinoma
- What is being tested?
- Interobserver agreement or Interrater agreement
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Innovative Digestive Health Education & Research Inc
New Brunswick, New Jersey, 08901
About this 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.
Read the 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
- Conditions
- Biliary Stricture, Pancreas Cancer, Cholangiocarcinoma, Bile Duct Cancer, Bile Duct Neoplasms Malignant, Bile Duct Neoplasms
- Being tested
- Interobserver agreement or Interrater agreement
- Keywords
- bile duct stricture, bile duct neoplasm, bile duct obstruction, bile duct lesion, cholangiocarcinoma, pancreatic duct stricture, pancreatic duct obstruction, pancreatic cancer, primary sclerosing cholangitis
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma, Bile Duct Neoplasms, Cholestasis, Bile Duct Diseases, Cholestasis, Extrahepatic, Adenoma, Bile Duct, Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interobserver agreement or Interrater agreementOther
Interobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures
| Study group | Role | What they receive |
|---|---|---|
| Expert Endoscopists | Experienced Endoscopists with significant user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures Receives: 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 Receives: Other: Interobserver agreement or Interrater agreement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interobserver agreement and diagnostic accuracy
Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity
Measured: 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
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start10 May 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Digestive Health Education and Research Inc
- Sponsor type
- University, hospital or other
- Collaborators
- NinePoint Medical
- Responsible party
- Sponsor
- Investigators
- Michel Kahaleh, MD, Principal investigator, Innovative Digestive Health Education and Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951324
- Sponsor's protocol ID
- 2565207-44318141
- Acronym
- VLE-IOV
- Status last verified
- Aug 2019
- First submitted
- 13 May 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
- ClinicalTrials.gov ID
- NCT03951324
- Acronym / sponsor ID
- VLE-IOV / 2565207-44318141
- Conditions
- Biliary Stricture, Pancreas Cancer, Cholangiocarcinoma, Bile Duct Cancer, Bile Duct Neoplasms Malignant, Bile Duct Neoplasms
- Keywords
- bile duct stricture, bile duct neoplasm, bile duct obstruction, bile duct lesion, cholangiocarcinoma, pancreatic duct stricture, pancreatic duct obstruction, pancreatic cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Innovative Digestive Health Education and Research IncUniversity, hospital or other
- Collaborators
- NinePoint Medical
- Study start
- 10 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expert Endoscopists | – | Other: Interobserver agreement or Interrater agreementExperienced Endoscopists with significant user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures |
| None-Expert Endoscopists | – | Other: Interobserver agreement or Interrater agreementExperienced Endoscopists with non-significant or beignner user experience with Volumetric Laser Endomicroscopy for bile duct/pancreatic duct strictures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interobserver agreement or Interrater agreementInterobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures | Other | Expert Endoscopists, None-Expert Endoscopists |
Primary outcome
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
1 secondary outcome
Number of procedures needed to view and conduct to use VLE for diagnostic confirmation
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Kahaleh, MD principal investigator
Innovative Digestive Health Education and Research Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Stricture and Pancreas Cancer, run by Innovative Digestive Health Education and Research Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interobserver agreement and diagnostic accuracy (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.