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Trial record 84 of 92 for:    Primary Sclerosing Cholangitis

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

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ClinicalTrials.gov Identifier: NCT03951324
Recruitment Status : Enrolling by invitation
First Posted : May 15, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
NinePoint Medical
Information provided by (Responsible Party):
Innovative Digestive Health Education and Research Inc

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.


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

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


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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




Primary Outcome Measures :
  1. Interobserver agreement and diagnostic accuracy [ Time Frame: 2 months ]
    Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity

  2. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951324


Locations
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United States, New Jersey
Innovative Digestive Health Education & Research Inc
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Innovative Digestive Health Education and Research Inc
NinePoint Medical
Investigators
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Principal Investigator: Michel Kahaleh, MD Innovative Digestive Health Education and Research Inc

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Responsible Party: Innovative Digestive Health Education and Research Inc
ClinicalTrials.gov Identifier: NCT03951324     History of Changes
Other Study ID Numbers: 2565207-44318141
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Innovative Digestive Health Education and Research Inc:
bile duct stricture
bile duct neoplasm
bile duct obstruction
bile duct lesion
cholangiocarcinoma
pancreatic duct stricture
pancreatic duct obstruction
pancreatic cancer
primary sclerosing cholangitis
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Adenoma
Cholangiocarcinoma
Bile Duct Neoplasms
Pancreatic Neoplasms
Adenoma, Bile Duct
Cholestasis
Bile Duct Diseases
Cholestasis, Extrahepatic
Constriction, Pathologic
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases