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Narrow Band Imaging Colon Polyp Study

16 de junio de 2010 actualizado por: Kansas City Veteran Affairs Medical Center

A Multicenter, Prospective, Randomized Controlled Trial for the Detection of Colon Polyps and Predicting Histology

In this study the investigators hypothesize that High Definition White Light colonoscopy and narrow band imaging (NBI) will detect a higher number of adenomas compared to standard definition white light colonoscopy. NBI will have a higher accuracy in predicting polyp histology compared to high definition colonoscopy and standard colonoscopy.

Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy, high-definition white light colonoscopy and NBI.

Specific Aim 2 - To compare the number of adenoma detected per subject by standard colonoscopy, high-definition white light colonoscopy and NBI.

Specific Aim 3 - To compare the accuracy of predicting polyp histology between standard colonoscopy, high-definition white light colonoscopy and NBI by evaluating the surface mucosal and vascular patterns during the procedure.

Specific Aim 4 - To determine the inter-observer agreement between investigators for the recognition of various polyp patterns

Descripción general del estudio

Descripción detallada

This study is a multi-center randomized controlled trial that will be conducted at the Kansas City VA Medical Center, Kansas City, MO and The Barnes Jewish Hospital, St Louis, MO. Patients referred for screening and surveillance colonoscopy will be enrolled. They will be randomized to one of the following three groups: standard white light colonoscopy, high-definition white light colonoscopy or NBI.

All colonoscopies will be performed at the Kansas City VA Medical Center and The Barnes Jewish Hospital, St Louis, MO. Moderate sedation will be administered for the procedure with intravenous midazolam, demerol or fentanyl and Propofol. In patients randomized to the NBI arm, the colonoscope will be inserted to the cecum under white light and will switch to NBI mode at the time of withdrawal. After cecal intubation, the colonic mucosa will be carefully visualized during withdrawal of the scope with one of the three imaging modalities to which the patient has been randomized. No effort will be made to look for polyps during the insertion of the colonoscope. All polyps detected will be documented for their size, morphology (Polypoid: sessile, pedunculated or Non polypoid: superficially elevated, completely flat, depressed), and location. The surface of the polyp will be assessed during the procedure and the histology will be predicted real time by evaluating the surface mucosal and vascular patterns. The patterns would be classified into one of the four patterns described in our pilot study (tubular and gyrus patterns will be combined to tubulogyrus pattern). Any other patterns detected would be described and kept in the miscellaneous category. If a pattern is not identified on a polyp with either white light or NBI, it will be recorded as such and no attempts will be made to predict histology. Photo documentation of the surface patterns of the polyps will be performed. Polyps will then be removed either with a biopsy forcep or snare and sent for histopathological evaluation. Each polyp removed will have one or more corresponding picture of its surface patterns and these will be labeled accordingly. The total time spent in inspecting the colonic mucosa (excluding the time spent in removal of polyps or clearing the colon of liquid and solid debris) will be measured with a stop watch. Representative images of the various polyp patterns will be reviewed, discussed and standardized amongst all the investigators at both sites. In addition, images of all the polyp patterns will be printed and posted in the endoscopy suites at both hospitals.

The bowel preparation will be evaluated and graded as follow:

Excellent (score=1) - >90% mucosa seen, mostly liquid colonic contents, minimal suctioning needed for adequate visualization.

Good (score=2) - >90% of mucosa seen, mostly liquid colonic contents, significant suctioning needed for adequate visualization Fair (score=3) - > 90% mucosa seen, mixture of liquid and semisolid colonic contents, could be suctioned and/or washed Inadequate (score=4) - <90% mucosa seen, mixture of semisolid ands solid colonic contents, which could not be suctioned or washed

Patients with "Inadequate" (score = 4) bowel prep will be excluded.

Tipo de estudio

Intervencionista

Inscripción (Actual)

630

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64128
        • Kansas City VA Medical Center
      • St. Louis, Missouri, Estados Unidos, 63110
        • Barnes Jewish Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

  • referral for screening or surveillance colonoscopy
  • the ability to provide informed consent

Exclusion criteria:

  • prior surgical resection of any portion of colon
  • prior history of colon cancer
  • history of inflammatory bowel disease
  • use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
  • poor general condition or any other reason to avoid prolonged procedure time
  • history of polyposis syndrome or HNPCC
  • inability to give informed consent.
  • Inadequate bowel preparation

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Standard White Light Colonoscopy

Standard White Light Colonoscopy

one exam per patient

High Definition White Light Colonoscopy

one exam per patient

Experimental: 2
High Definition White Light Colonoscopy

Standard White Light Colonoscopy

one exam per patient

High Definition White Light Colonoscopy

one exam per patient

Experimental: 3
Narrow Band Imaging Colonoscopy

Narrow Band Imaging Colonoscopy

one exam per patient

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The prevalence of adenomas in the three arms of the study.
Periodo de tiempo: 2 years
Number of subjects with adenomas in the three arms of the study
2 years

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Secondary outcome will be number of adenomas detected per subject in the three arms, the sensitivity, specificity, and accuracy of predicting polyp histology real time by the three imaging modalities.
Periodo de tiempo: 2 years
2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Amit Rastogi, MD, Kansas City VA Medical Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2008

Finalización primaria (Actual)

1 de noviembre de 2009

Finalización del estudio (Actual)

1 de diciembre de 2009

Fechas de registro del estudio

Enviado por primera vez

31 de enero de 2008

Primero enviado que cumplió con los criterios de control de calidad

31 de enero de 2008

Publicado por primera vez (Estimar)

13 de febrero de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

17 de junio de 2010

Última actualización enviada que cumplió con los criterios de control de calidad

16 de junio de 2010

Última verificación

1 de junio de 2010

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • AR0003

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. .

Ensayos clínicos sobre standard of care colonoscopy

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