- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02166086
Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders
Advanced Imaging for Diagnosing Pancreatico-biliary Disorders: A Multicenter Registry.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- Weill Cornell Medical College
-
Contact:
- Monica R Gaidhane, MD
- Phone Number: 646-962-4796
- Email: mog2012@med.cornell.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Endoscopic imaging
Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
|
Endoscopy involving advanced imaging techniques
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy Profile
Time Frame: 1 year
|
Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable analyses.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival duration
Time Frame: 1 year or more
|
Documentation of follow up diagnoses variable and survival duration (in days).
|
1 year or more
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Safety Profile
Time Frame: 30 days
|
Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.
|
30 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1111012020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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