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 juillet 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
58
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Capital Federal, Argentine, C1100AAF
- Hospital Italiano de Buenos Aires
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
5 mois à 17 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall survival at 1 year.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Micaela Raices, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Chaise d'étude: Matias E Czerwonko, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Chaise d'étude: Victoria Ardiles, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Chaise d'étude: Gustavo Boldrini, Physician, Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Chaise d'étude: Daniel D'Agostino, Physician, Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Chaise d'étude: José Marcó del Pont, Physician, Department of Pediatrics, Division of Pediatric Infectious Diseases, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Chaise d'étude: Juan Pekolj, Doctor, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Chaise d'étude: Eduardo de Santibañes, Doctor, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Directeur d'études: Martin de Santibañes, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
21 avril 2018
Achèvement primaire (Réel)
3 juin 2018
Achèvement de l'étude (Réel)
3 juin 2018
Dates d'inscription aux études
Première soumission
16 juin 2018
Première soumission répondant aux critères de contrôle qualité
19 juillet 2018
Première publication (Réel)
20 juillet 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 juillet 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 juillet 2018
Dernière vérification
1 juillet 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 321654
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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