- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02166086
Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders
Advanced Imaging for Diagnosing Pancreatico-biliary Disorders: A Multicenter Registry.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10021
- Recrutement
- Weill Cornell Medical College
-
Contact:
- Monica R Gaidhane, MD
- Numéro de téléphone: 646-962-4796
- E-mail: mog2012@med.cornell.edu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Efficacy Profile
Délai: 1 year
|
Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable analyses.
|
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Survival duration
Délai: 1 year or more
|
Documentation of follow up diagnoses variable and survival duration (in days).
|
1 year or more
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Efficacy
Délai: 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
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Safety Profile
Délai: 30 days
|
Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.
|
30 days
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1111012020
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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