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Trial NCT00779688

Resource URI: http://static.linkedct.org/resource/trials/NCT00779688
PropertyValue
linkedct:biospec_retention None Retained
linkedct:brief_title A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1214>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/2470>
linkedct:condition <http://static.linkedct.org/resource/condition/1588>
linkedct:condition <http://static.linkedct.org/resource/condition/9587>
linkedct:criteria Inclusion Criteria: 1. Male or female > 18 years of age 2. Willing and able to comply with Registry procedures and provide written informed consent to participate in the Registry 3. Indicated for ERCP and/or cholangiopancreatoscopy 4. Indeterminate or suspected biliary and/or pancreatic stricture, mass, or neoplasm Exclusion Criteria: 1. Subjects for whom ERCP procedures are contraindicated 2. Known allergy to fluorescein dye
linkedct:description This is a registry study to collect high quality longitudinal data from patients with suspected or indeterminate pancreaticobiliary pathology who are undergoing an ERCP with Cellvizio probe-based endomicroscopy procedure, with or without supplemental direct cholangiopancreatoscopy. The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone. Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary and/or pancreatic duct lesions will be compared for the combination of endomicroscopy and ERCP imaging and ERCP alone. These presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). Secondary objectives include collecting various safety and technical performance parameters.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:eligibility_sampling_method Non-Probability Sample
linkedct:eligibility_study_pop Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers
linkedct:end_date September 2010
linkedct:enrollment 130 (xsd:int)
linkedct:firstreceived_date October 22, 2008
linkedct:has_dmc No
linkedct:id NCT00779688
linkedct:intervention <http://static.linkedct.org/resource/intervention/107699>
rdfs:label Trial NCT00779688
linkedct:lastchanged_date October 8, 2009
linkedct:lead_sponsor_agency Mauna Kea Technologies
linkedct:location <http://static.linkedct.org/resource/location/148181>
linkedct:location <http://static.linkedct.org/resource/location/154041>
linkedct:location <http://static.linkedct.org/resource/location/157894>
linkedct:location <http://static.linkedct.org/resource/location/205119>
linkedct:location <http://static.linkedct.org/resource/location/291638>
linkedct:location <http://static.linkedct.org/resource/location/295862>
linkedct:nct_id NCT00779688
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 1 (xsd:int)
linkedct:official_title Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database
linkedct:org_study_id MKT-2008-ERCP-01
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/62245>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1123>
linkedct:oversight <http://static.linkedct.org/resource/oversight/2938>
linkedct:oversight <http://static.linkedct.org/resource/oversight/960>
foaf:page <http://clinicaltrials.gov/show/NCT00779688>
linkedct:phase N/A
linkedct:primary_completion_date September 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/32717>
linkedct:secondary_id WIRB 20081709
linkedct:source Mauna Kea Technologies
linkedct:start_date November 2008
linkedct:study_design Other, Prospective
linkedct:study_type Observational
linkedct:summary This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.
rdf:type linkedct:trials
linkedct:verification_date October 2009