Clinical trial NCT03951324: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
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
Lead sponsor: Innovative Digestive Health Education and Research Inc
Sponsor class: OTHER
Collaborators: name: NinePoint Medical
First posted: 2019-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Interobserver agreement and diagnostic accuracy
timeFrame: 2 months
measure: Frequency and type of criteria visually identified on malignant VLE clips
timeFrame: 2 months
Secondary outcomes:
measure: Number of procedures needed to view and conduct to use VLE for diagnostic confirmation
timeFrame: 2 months
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Innovative Digestive Health Education & Research Inc
state: New Jersey
Study officials:
affiliation: Innovative Digestive Health Education and Research Inc
name: Michel Kahaleh, MD
role: PRINCIPAL_INVESTIGATOR
References: