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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

58

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Capital Federal, Argentina, C1100AAF
        • Hospital Italiano de Buenos Aires

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

5 månader till 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Hyper-reduced liver recipients.
Low-weight children who underwent live donor liver transplantation with ultrasound-guided in situ left lateral segment graft hyper-reduction.
Procedur: Liver transplantation with hyper-reduced grafts
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall survival at 1 year.
Tidsram: Overall survival wil be reported at 1 year after liver transplantation.
Overall survival was defined as the time from surgery to death (all causes) or date of last follow-up, measured in months.
Overall survival wil be reported at 1 year after liver transplantation.
Overall survival at 3 years.
Tidsram: Overall survival wil be reported at 3 years after liver transplantation.
Overall survival was defined as the time from surgery to death (all causes) or date of last follow-up, measured in months.
Overall survival wil be reported at 3 years after liver transplantation.
Overall survival at 10 years.
Tidsram: Overall survival wil be reported at 10 years after liver transplantation.
Overall survival was defined as the time from surgery to death (all causes) or date of last follow-up, measured in months.
Overall survival wil be reported at 10 years after liver transplantation.
Graft survival at 1 year.
Tidsram: Graft survival wil be reported at 1 year after liver transplantation.
Graft survival was defined as the time from surgery to the date of re-transplantation or re-entry to waiting list, measured in months.
Graft survival wil be reported at 1 year after liver transplantation.
Graft survival at 3 years.
Tidsram: Graft survival wil be reported at 3 years after liver transplantation.
Graft survival was defined as the time from surgery to the date of re-transplantation or re-entry to waiting list, measured in months.
Graft survival wil be reported at 3 years after liver transplantation.
Graft survival at 10 years.
Tidsram: Graft survival wil be reported at 10 years after liver transplantation.
Graft survival was defined as the time from surgery to the date of re-transplantation or re-entry to waiting list, measured in months.
Graft survival wil be reported at 10 years after liver transplantation.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hospital Italiano de Buenos Aires

Utredare

  • Huvudutredare: 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.
  • Studierektor: Martin de Santibañes, Physician, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 april 2018

Primärt slutförande (Faktisk)

3 juni 2018

Avslutad studie (Faktisk)

3 juni 2018

Studieregistreringsdatum

Först inskickad

16 juni 2018

Först inskickad som uppfyllde QC-kriterierna

19 juli 2018

Första postat (Faktisk)

20 juli 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 juli 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 juli 2018

Senast verifierad

1 juli 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 321654

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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