- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00279357
Randomised Trial of NBI for Adenoma Detection
Randomised, Controlled Trial of Narrow Band Imaging (NBI) Versus Standard Endoscopy for Adenoma Detection
Does a new colonoscopic viewing technique called narrow band imaging (NBI) help doctors detect more patients with at least one pre-cancerous polyp (adenoma) than conventional colonoscopy using white light alone?
May 2007 protocol minor amendment: additional viewing by endoscopists outside St Mark's ro allow assessment of inter- and intra-observer variability.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Colorectal cancer is the second commonest cause of cancer death. In a majority of cases it is preceded by a precancerous lesion called an adenoma (polyp). Detection and removal of adenomas at colonoscopy has been shown to reduce the death rate from colorectal cancer. However, despite meticulous examination there is a "miss rate" for adenomas at colonoscopy which ranges from 66-25% in back-to-back colonoscopy studies. The nature of the polyps which as well as being pedunculated (cherry like) can be flat or depressed making them difficult to see, which may contribute to the "miss rate".
The factors, which influence the endoscopist detection are not well studied. Polyp detection rates wary widely, even among experts. Techniques that highlight lesions have advanced in recent years. Chromoendoscopy, the current gold standard technique, relies on spraying dye on the bowel lining, has been shown to help pick up more pre-cancerous polyps in two of three studies; however it is not widely used as it is time consuming and requires extra equipment and training. Narrow band imaging (NBI) is a technique that relies in light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up adenomas as they have a richer vascular network. It is sometimes described as "digital chromoendoscopy" as the images produced are similar to chromoendoscopy, but it is much simpler and quicker to use. Autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out. These techniques have been used with some success in the oesophagus and stomach but little work is available for the colon.
We aim to see if NBI is better than standard colonoscopy for detecting precancerous polyps. This is likely as it is similar to chromoendoscopy which is already shown to help. If a polyp is found we will use other types of endoscopy, particularly NBI with magnification and autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous polyps.
May 2007 protocol minor amendment: additional viewing by endoscopists outside St Mark's ro allow assessment of inter- and intra-observer variability. No additional data collected.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Brian Saunders, MD FRCP
- Correo electrónico: b.saunders@imperial.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: James East, MBChB MRCP
- Correo electrónico: jameseast@yahoo.com
Ubicaciones de estudio
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London, Reino Unido, HA1 3UJ
- Reclutamiento
- North West London Hospitals NHS Trust - St Mark's
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Contacto:
- Alan Warnes, PhD
- Correo electrónico: alan.warnes@nwlh.nhs.uk
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Investigador principal:
- Brian Saunders, MD FRCP
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Contacto:
- Iva Hauptmannova, BSc MA
- Correo electrónico: iva.hauptmannova@nwlh.nhs.uk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patients over 18 years of age, patients in a high risk group for adenomas
Exclusion Criteria:
- patients with known colitis or polyposis, unable or unwilling to give informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Difference in number of patients with at least one histologically demonstrated adenoma between the two groups
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Medidas de resultado secundarias
Medida de resultado |
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Number of adenomas detected in each arm
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number of advance adenomas (>20% villous elements, >10mm, high grade dysplasia) detected in each arm
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Total number of flat adenomas detected in each arm
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total number of non-neoplastic lesion in each arm
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total number of patients with 3 or more adenomas detected in each arm
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total number of patients with 5 or more adenomas detected in each arm
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assessment of video still for detection of neo-plastic or non-plastic nature of polyps, AFI, vs NBI vs NBI with magnification versus white light
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Sub-group analysis of primary end point according to indication for colonoscopy
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Brian Saunders, MD FRCP, London North West Healthcare NHS Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 05/NBI/121
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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