Outcomes of Liver Transplantation in Low Weight Children After Reducing the Lateral Segment of a Living Donor, Adapting the Shape and Size of the Graft to the Needs of the Recipient
19 de julio de 2018 actualizado por: MICAELA RAICES, Hospital Italiano de Buenos Aires
Short and Long-term Outcomes After Transplantation With Hyper-reduced Liver Grafts in Low-Weight Pediatric Recipients
The shortage of organs has always been a problem in pediatric liver transplants due to the lack of donors with an adequate size.
Different techniques of hepatic reduction have been described that allow to use larger organs in the pediatric population.
However, in these techniques the maximum reduction achieved by segments 2 and 3 is excessive for low-weight children.
Since 1997 the liver transplantation group at Hospital Italiano de Buenos Aires has developed and practiced a technique called hepatic hyper-reduction, which consists in reducing the lateral segment of a living donor, adapting the shape and size of the graft to the needs of the recipient.
The investigators have performed approximately 50 pediatric liver transplants with live donors in low weight children in whom the hyper-reduction technique has been applied.
The aim of the present study is to describe postoperative morbidity and mortality and analyze overall and graft survival.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
58
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
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Capital Federal, Argentina, C1100AAF
- Hospital Italiano de Buenos Aires
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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
5 meses a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
All pediatric patients undergoing living donor liver transplantation with hyper-reduced liver grafts at the Liver Transplantation Unit of the Hospital Italiano de Buenos Aires between June 1997 and April 2018
Descripción
Inclusion Criteria:
- < or = 17 years old.
- Having undergone live donor liver transplantation.
- Having received hyper-reduced liver grafts
- At the Liver Transplantation Unit of the Hospital Italiano de Buenos Aires
- Between June 1997 and April 2018
Exclusion Criteria:
- > 17 years old.
- Cadaveric liver transplant
- Whole liver grafts.
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Hyper-reduced liver recipients.
Low-weight children who underwent live donor liver transplantation with ultrasound-guided in situ left lateral segment graft hyper-reduction.
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Live donor liver transplantation using non-anatomical in-situ ultrasound-guided reduction of left lateral segments with preparation of a graft that is larger than a monosegment, but smaller than Segments 2 and 3.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall survival at 1 year.
Periodo de tiempo: Overall survival wil be reported at 1 year after liver transplantation.
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Overall survival was defined as the time from surgery to death (all causes) or date of last follow-up, measured in months.
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Overall survival wil be reported at 1 year after liver transplantation.
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Overall survival at 3 years.
Periodo de tiempo: Overall survival wil be reported at 3 years after liver transplantation.
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Overall survival was defined as the time from surgery to death (all causes) or date of last follow-up, measured in months.
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Overall survival wil be reported at 3 years after liver transplantation.
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Overall survival at 10 years.
Periodo de tiempo: Overall survival wil be reported at 10 years after liver transplantation.
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Overall survival was defined as the time from surgery to death (all causes) or date of last follow-up, measured in months.
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Overall survival wil be reported at 10 years after liver transplantation.
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Graft survival at 1 year.
Periodo de tiempo: Graft survival wil be reported at 1 year after liver transplantation.
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Graft survival was defined as the time from surgery to the date of re-transplantation or re-entry to waiting list, measured in months.
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Graft survival wil be reported at 1 year after liver transplantation.
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Graft survival at 3 years.
Periodo de tiempo: Graft survival wil be reported at 3 years after liver transplantation.
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Graft survival was defined as the time from surgery to the date of re-transplantation or re-entry to waiting list, measured in months.
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Graft survival wil be reported at 3 years after liver transplantation.
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Graft survival at 10 years.
Periodo de tiempo: Graft survival wil be reported at 10 years after liver transplantation.
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Graft survival was defined as the time from surgery to the date of re-transplantation or re-entry to waiting list, measured in months.
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Graft survival wil be reported at 10 years after liver transplantation.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Micaela Raices, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Silla de estudio: Matias E Czerwonko, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Silla de estudio: Victoria Ardiles, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Silla de estudio: Gustavo Boldrini, Physician, Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Silla de estudio: Daniel D'Agostino, Physician, Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Silla de estudio: José Marcó del Pont, Physician, Department of Pediatrics, Division of Pediatric Infectious Diseases, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Silla de estudio: Juan Pekolj, Doctor, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Silla de estudio: Eduardo de Santibañes, Doctor, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Director de estudio: Martin de Santibañes, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
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 (Actual)
21 de abril de 2018
Finalización primaria (Actual)
3 de junio de 2018
Finalización del estudio (Actual)
3 de junio de 2018
Fechas de registro del estudio
Enviado por primera vez
16 de junio de 2018
Primero enviado que cumplió con los criterios de control de calidad
19 de julio de 2018
Publicado por primera vez (Actual)
20 de julio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de julio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
19 de julio de 2018
Última verificación
1 de julio de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 321654
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