- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03594864
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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
58
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Capital Federal, Argentina, C1100AAF
- Hospital Italiano de Buenos Aires
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
5 måneder til 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Overall survival at 1 year.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Micaela Raices, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studiestol: Matias E Czerwonko, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studiestol: Victoria Ardiles, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studiestol: Gustavo Boldrini, Physician, Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studiestol: Daniel D'Agostino, Physician, Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studiestol: José Marcó del Pont, Physician, Department of Pediatrics, Division of Pediatric Infectious Diseases, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studiestol: Juan Pekolj, Doctor, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studiestol: Eduardo de Santibañes, Doctor, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
- Studieleder: Martin de Santibañes, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. april 2018
Primær fullføring (Faktiske)
3. juni 2018
Studiet fullført (Faktiske)
3. juni 2018
Datoer for studieregistrering
Først innsendt
16. juni 2018
Først innsendt som oppfylte QC-kriteriene
19. juli 2018
Først lagt ut (Faktiske)
20. juli 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. juli 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. juli 2018
Sist bekreftet
1. juli 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 321654
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