Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders
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|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
|Condition or disease||Intervention/treatment|
|Diagnosis of a Pancreaticobiliary Disorder||Procedure: Endoscopy|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|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|
Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
Endoscopy involving advanced imaging techniques
- Efficacy Profile [ Time Frame: 1 year ]Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable analyses.
- Survival duration [ Time Frame: 1 year or more ]Documentation of follow up diagnoses variable and survival duration (in days).
- 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.
- Safety Profile [ Time Frame: 30 days ]Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.
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
|Contact: Michel Kahaleh, MDfirstname.lastname@example.org|
|Contact: Monica R Gaidhane, MPHemail@example.com|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10021|
|Contact: Michel Kahaleh, MD 646-962-4797 firstname.lastname@example.org|
|Contact: Monica R Gaidhane, MD 646-962-4796 email@example.com|
|Principal Investigator: Michel Kahaleh, MD|
|Principal Investigator:||Michel Kahaleh, MD||Weill Medical College of Cornell University|