Flexible Endoscopy Biopsies for Submucous Tumors With a New Drill Instrument
Flexible Endoscopy Biopsies With the New Drill Biopsy Instrument for Submucous Tumors
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: With the existing biopsy instruments for flexible endoscopy it's only possible to achieve superficial biopsies comprising the mucosa and very seldom some small fragments of the submucosa. It is, however, increasingly important to get biopsies from the submucous tissues because the tumors that are on the increase more than any other in the stomach is the GIST (GastroIntestinal Stroma Tumours) that grows in the submucosa. Cytology is not enough for a reliable diagnosis and to often not representative. Furthermore there is a well-known risk for tract seeding when sampling through the abdominal wall with a fine needle instrument.
The investigators have invented a new biopsy instrument for flexible endoscopy that is a drill within a cylinder that can be used for biopsies of the submucous tissues, for instance GIST-tumours, see www.BIBBInstruments.com.
Hypothesis: Will it be possible to achieve representative submucous tissue from the gastrointestinal tract with the newly constructed drill biopsy instrument for flexible endoscopy. The investigators hypothesize that the amount of tissue harvested with the new drill biopsy instrument will give significantly more amount of tissue to evaluate for the pathologist than the existing biopsy forceps.
Method: Ten patients with tumours in the submucosa of the stomach are examined with a gastroscope. The investigator decides where the first biopsy should be taken and randomly the investigator blindly get the new drill instrument or the conventional biopsy forceps and take the biopsy on the decided localization. The next site of the tumour is decided and again blindly the investigator get one of the two biopsy instruments according to a previously decided scheme. Six biopsies (three with each of the two biopsy tools) in every patient are harvested in ten patients. With altogether 30 specimen for each biopsy instrument and a difference of 1/3 which is a low calculated difference 10 patients as above will give a 80 % Power (Chi-2 = 5.40, p = 0.02*). The amount of submucous tissue harvested with the two biopsy instruments are measured in microgram and as percentage of all the biopsy and compared. The quality of the specimens are also calculated.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lund, Suecia, SE-22185
- Department of Surgery, Lund University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Submucous gastrointestinal tumours
Exclusion Criteria:
- No gastrointestinal submucous tumor
- Submucosal hemangioma
Plan de estudios
¿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 |
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Comparador activo: New drill biopsy instrument
To take biopsies from gastric submucosal tumors with a new drill biopsy instrument used with flexible endoscopes.
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Biopsies taken with the new drill biopsy instrument for flexible endoscopy
Otros nombres:
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Comparador activo: Conventional biopsy instrument
To take biopsies from gastric submucosal tumors with conventional biopsy forceps used with flexible endoscopes
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Biopsies taken with conventional biopsy forceps for flexible endoscopic instruments
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Amount of submucous tissue in gastrointestinal submucosal tumors harvested with a new drill biopsy instrument used with flexible endoscopes.
Periodo de tiempo: Within 30 days for each patient
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Amount of submucous tissue adequate for histological examination harvested with the new drill biopsy instrument for flexible endoscopy and compared to the amount harvested with the existing biopsy forceps in a randomized setting.
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Within 30 days for each patient
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bruno S Walther, MD, Professor
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- 2014/97
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