Diagnosis of a Pancreaticobiliary Disorder Clinical Trial
Official title:
Advanced Imaging for Diagnosing Pancreatico-biliary Disorders: A Multicenter Registry.
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.
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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