Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02166086

Collaborator

(none)

500

Enrollment

Location

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this registry is to record information and evaluate the impact of advanced imaging techniques on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by advanced imaging techniques.

Condition or Disease	Intervention/Treatment	Phase
Diagnosis of a Pancreaticobiliary Disorder	Procedure: Endoscopy

Detailed Description

Advanced imaging techniques such as SpyGlass or pCLE (probe-based Confocal laser endomicroscopy) using Cellvizio probes enable high sensitive and specific diagnosis of strictures or tumors in bile and pancreatic ducts. However, advanced endoscopists have only recently started to employ such techniques for diagnostic purposes. Hence we lack enough data to evaluate the sensitivity, specificity, accuracy, technical feasibility and safety of such imaging devices. Evaluation of these factors would help us compare them to conventional diagnostic options; and consequently help us identify appropriate advanced imaging techniques for biliary and pancreatic disorders and improve clinical management of patients.

This multi-center registry has been initiated:

To document the impact of advanced imaging techniques in pancreatico-biliary disorders on the clinical management of pancreatico-biliary disorders including malignancies.
To assess the sensitivity, specificity, accuracy, technical feasibility and safety of advanced imaging techniques in pancreatico-biliary disorders.

The registry will review and document:

All patients who have had advanced imaging done for pancreatico-biliary disorders.
No subject intervention is involved in this study. Subject contact is not needed for database review.

Study Design at Secondary sites:

Other sites must have either a database review protocol and/or a clinical trial that would collect data on advanced imaging done for pancreatico-biliary disorders prior to participating in the registry.
These sites would have IRB approved protocols to collect and send advanced imaging procedure data to the primary site (WCMC). Additionally, the secondary study sites would mention WCMC as an entity that could receive PHI in their respective protocols and consent/HIPAA forms.
All secondary study sites' IRB approvals will be sent to the primary/coordinating study center at WCMC. The primary center will then forward these IRB approvals to WCMC IRB as soon as they are received from the secondary study sites.
Relevant IRB documentation will be maintained at both primary and secondary sites.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Advanced Imaging for Diagnosing Pancreatico-biliary Disorders: A Multicenter Registry.

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Endoscopic imaging Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.	Procedure: Endoscopy Endoscopy involving advanced imaging techniques

Arm

Intervention/Treatment

Endoscopic imaging

Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.

Procedure: Endoscopy

Endoscopy involving advanced imaging techniques

Outcome Measures

Primary Outcome Measures

Efficacy Profile [1 year]
Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable analyses.

Secondary Outcome Measures

Survival duration [1 year or more]
Documentation of follow up diagnoses variable and survival duration (in days).

Other Outcome Measures

Efficacy [1 year]
Documentation of technical success and clinical success rates. Technical success will be recorded as procedure success and capturing of relevant advanced imaging. Clinical success will be recorded as if a diagnosis was made based on the advanced imaging results.
Safety Profile [30 days]
Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
Above 18 years of age.

Exclusion Criteria:

Any patient who has not undergone advanced imaging techniques for pancreatico-biliary disorders.
Below 18 years of age.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10021

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator: Michel Kahaleh, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michel Kahaleh, Chief of Endoscopy, Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT02166086

Other Study ID Numbers:

1111012020

First Posted:

Jun 18, 2014

Last Update Posted:

Feb 20, 2017

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Study Results

No Results Posted as of Feb 20, 2017