Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders

NCT ID: NCT02166086

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2018-12-30

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.

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.

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.

Conditions

Diagnosis of a Pancreaticobiliary Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Endoscopic imaging

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

Endoscopy

Intervention Type: PROCEDURE

Endoscopy involving advanced imaging techniques

Interventions

Endoscopy

Endoscopy involving advanced imaging techniques

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Michel Kahaleh

Chief of Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Kahaleh, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michel Kahaleh, MD

Role: CONTACT

mik9071@med.cornell.edu

646-962-4797

Monica R Gaidhane, MPH

Role: CONTACT

mog2012@med.cornell.edu

646-962-4796

Facility Contacts

Michel Kahaleh, MD

Role: primary

mkahaleh@gmail.com

646-962-4797

Monica R Gaidhane, MD

Role: backup

mog2012@med.cornell.edu

646-962-4796

References

Tyberg A, Xu MM, Gaidhane M, Kahaleh M. Second generation optical coherence tomography: Preliminary experience in pancreatic and biliary strictures. Dig Liver Dis. 2018 Nov;50(11):1214-1217. doi: 10.1016/j.dld.2018.05.019. Epub 2018 Jun 8.

Reference Type: DERIVED

PMID: 29937365 (View on PubMed)

Karia K, Waxman I, Konda VJ, Gress FG, Sethi A, Siddiqui UD, Sharaiha RZ, Kedia P, Jamal-Kabani A, Gaidhane M, Kahaleh M. Needle-based confocal endomicroscopy for pancreatic cysts: the current agreement in interpretation. Gastrointest Endosc. 2016 May;83(5):924-7. doi: 10.1016/j.gie.2015.08.080. Epub 2015 Sep 14.

Reference Type: DERIVED

PMID: 26382051 (View on PubMed)

Karia K, Jamal-Kabani A, Gaidhane M, Tyberg A, Sharaiha RZ, Kahaleh M. Probe-Based Confocal Endomicroscopy in Primary Sclerosing Cholangitis: Not All Inflammatory Strictures Are the Same. Dig Dis Sci. 2016 Jan;61(1):283-6. doi: 10.1007/s10620-015-3827-1. Epub 2015 Aug 2.

Reference Type: DERIVED

PMID: 26233552 (View on PubMed)

Other Identifiers

1111012020

Identifier Type: -

Identifier Source: org_study_id