pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture (FOCUS)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This trial aims at evaluating the performance diagnosis of pCLE for the detection of bile duct cancer, in patients with indeterminate biliary stricture when associated with other diagnostic information.
The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone or ERCP with tissue sampling, by improving the sensitivity of detection and by providing a real-time diagnosis.
Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary duct lesions will be compared for the combination of ERCP alone, endomicroscopy plus ERCP imaging, and ERCP plus endomicroscopy plus tissue sampling. These information will be reviewed retrospectively by a second physician.
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 patient management recommendation. Yet, effective management recommendation is left as the discretion of the physician.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale New Haven Hospital
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New York
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New york, New York, Estados Unidos, 10065
- New York Presbyterian Weill Cornell Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
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Washington
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Seattle, Washington, Estados Unidos, 98111
- Virginia Mason Medical Center
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Marseille, Francia, 13000
- Institut Paoli Calmettes
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Roma, Italia, 00168
- Policlinico Univertitario Agostino Gemelli
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Male or female > 18 years of age
- Indicated for ERCP for indeterminate bile duct stricture
- Referral patients with indeterminate biliary stricture coming in for first ERCP procedure at referral institution or
- Patients who had previous non-diagnostic tissue sampling (brushing biopsies or EUS-FNA) taken during a previous ERCP or EUS-FNA for an indeterminate biliary stricture
- Willing and able to comply with study procedures and provide written informed consent to participate in the study
Exclusion Criteria:
- Subjects for whom ERCP procedures are contraindicated
- Known allergy to fluorescein dye
- Patients suffering Primary Sclerosing Cholangitis or chronic pancreatitis.
- Patients with post-transplant stricture
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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pCLE
This trial will study only one group which will receive a standard ERCP procedure followed by pCLE
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
Periodo de tiempo: 12 months
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Evaluation of pCLE diagnostic performance for the diagnosis of indeterminate biliary stricture (ie.
number of patients accurately diagnosed) when associated with other diagnostic information The following calculations will be conducted: sensitivity, specificity, positive and negative predictive values, Accuracy
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
Periodo de tiempo: 12 months follow-up
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12 months follow-up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Adam Slivka, MD, University of Pittsburh Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MKT-2011-FOCUS
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