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Completed

NCT Number: 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

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.

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Key information

Conditions

Liver Transplantation Hyper-reduced Liver Grafts Low-weight Children

Age range

5 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Italiano de Buenos Aires

Capital Federal, C1100AAF, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liver transplantation with hyper-reduced grafts

Procedure

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.

Primary outcomes

  1. Overall survival at 1 year.

    Time frame: 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.

  2. Overall survival at 3 years.

    Time frame: 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.

  3. Overall survival at 10 years.

    Time frame: 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.

  4. Graft survival at 1 year.

    Time frame: 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.

  5. Graft survival at 3 years.

    Time frame: 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.

  6. Graft survival at 10 years.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

Short and Long-term Outcomes After Transplantation With Hyper-reduced Liver Grafts in Low-Weight Pediatric Recipients

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 20, 2018
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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