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Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02166086
Recruitment Status : Unknown
Verified February 2017 by Michel Kahaleh, Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
First Posted : June 18, 2014
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University

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
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.

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Advanced Imaging for Diagnosing Pancreatico-biliary Disorders: A Multicenter Registry.
Study Start Date : September 2011
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Efficacy Profile [ Time Frame: 1 year ]
    Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable analyses.


Secondary Outcome Measures :
  1. Survival duration [ Time Frame: 1 year or more ]
    Documentation of follow up diagnoses variable and survival duration (in days).


Other Outcome Measures:
  1. Efficacy [ Time Frame: 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.

  2. Safety Profile [ Time Frame: 30 days ]
    Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166086


Contacts
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Contact: Michel Kahaleh, MD 646-962-4797 mik9071@med.cornell.edu
Contact: Monica R Gaidhane, MPH 646-962-4796 mog2012@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Michel Kahaleh, MD    646-962-4797    mkahaleh@gmail.com   
Contact: Monica R Gaidhane, MD    646-962-4796    mog2012@med.cornell.edu   
Principal Investigator: Michel Kahaleh, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Michel Kahaleh, MD Weill Medical College of Cornell University

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michel Kahaleh, Chief of Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02166086     History of Changes
Other Study ID Numbers: 1111012020
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Pathologic Processes