Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders

Diagnosis of a Pancreaticobiliary Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02166086
• Other study ID #: 1111012020
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2014
• Last updated: February 16, 2017
• Start date: September 2011
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: Michel Kahaleh, MD
• Phone: 646-962-4797
• Email: mik9071[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diagnosis of a Pancreaticobiliary Disorder
• Disease

Intervention

Procedure:
• Endoscopy
Endoscopy involving advanced imaging techniques

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy	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.	1 year
Other	Safety Profile	Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.	30 days
Primary	Efficacy Profile	Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable analyses.	1 year
Secondary	Survival duration	Documentation of follow up diagnoses variable and survival duration (in days).	1 year or more