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 juli 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Werkelijk)
58
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Capital Federal, Argentinië, C1100AAF
- Hospital Italiano de Buenos Aires
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
5 maanden tot 17 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall survival at 1 year.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Micaela Raices, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studie stoel: Matias E Czerwonko, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studie stoel: Victoria Ardiles, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studie stoel: Gustavo Boldrini, Physician, Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studie stoel: Daniel D'Agostino, Physician, Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studie stoel: José Marcó del Pont, Physician, Department of Pediatrics, Division of Pediatric Infectious Diseases, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studie stoel: Juan Pekolj, Doctor, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studie stoel: Eduardo de Santibañes, Doctor, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studie directeur: Martin de Santibañes, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
21 april 2018
Primaire voltooiing (Werkelijk)
3 juni 2018
Studie voltooiing (Werkelijk)
3 juni 2018
Studieregistratiedata
Eerst ingediend
16 juni 2018
Eerst ingediend dat voldeed aan de QC-criteria
19 juli 2018
Eerst geplaatst (Werkelijk)
20 juli 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 juli 2018
Laatste update ingediend die voldeed aan QC-criteria
19 juli 2018
Laatst geverifieerd
1 juli 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 321654
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