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

Cholangiocarcinoma Clinical Trial

— VLE-IOV  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03951324
• Other study ID #: 2565207-44318141
• Status: Enrolling by invitation
• Start date: May 10, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: Innovative Digestive Health Education and Research Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenoma
• Adenoma, Bile Duct
• Bile Duct Adenoma
• Bile Duct Cancer
• Bile Duct Diseases
• Bile Duct Lesions
• Bile Duct Neoplasms
• Bile Duct Neoplasms Malignant
• Bile Duct Obstruction
• Bile Duct Obstruction, Extrahepatic
• Bile Duct Stenosi
• Biliary Stricture
• Cholangiocarcinoma
• Cholangitis
• Cholangitis, Sclerosing
• Cholestasis
• Cholestasis, Extrahepatic
• Constriction, Pathologic
• Neoplasms
• Pancreas Cancer
• Pancreatic Duct Obstruction
• Pancreatic Duct Stenosis
• Pancreatic Duct Stricture
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms
• Primary Sclerosing Cholangitis

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

Locations

Country	Name	City	State
United States	Innovative Digestive Health Education & Research Inc	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Innovative Digestive Health Education and Research Inc	NinePoint Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interobserver agreement and diagnostic accuracy	Interobserver study for criteria validation and accuracy, PPV and NPV, sensitivity and specificity	2 months
Primary	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	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