Clinical trial 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
Official title: Short and Long-term Outcomes After Transplantation With Hyper-reduced Liver Grafts in Low-Weight Pediatric Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Low-weight Children
Hyper-reduced Liver Grafts
Keywords: Liver
Transplantation
Hyper-reduction
Graft survival
Overall survival
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 58
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival at 1 year.
timeFrame: Overall survival wil be reported at 1 year after liver transplantation.
measure: Overall survival at 3 years.
timeFrame: Overall survival wil be reported at 3 years after liver transplantation.
measure: Overall survival at 10 years.
timeFrame: Overall survival wil be reported at 10 years after liver transplantation.
measure: Graft survival at 1 year.
timeFrame: Graft survival wil be reported at 1 year after liver transplantation.
measure: Graft survival at 3 years.
timeFrame: Graft survival wil be reported at 3 years after liver transplantation.
measure: Graft survival at 10 years.
timeFrame: Graft survival wil be reported at 10 years after liver transplantation.
Secondary outcomes:
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
name: Micaela Raices, Physician
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
name: Matias E Czerwonko, Physician
role: STUDY_CHAIR
affiliation: Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
name: Victoria Ardiles, Physician
role: STUDY_CHAIR
affiliation: Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
name: Gustavo Boldrini, Physician
role: STUDY_CHAIR
affiliation: Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
name: Daniel D'Agostino, Physician
role: STUDY_CHAIR
affiliation: Department of Pediatrics, Division of Pediatric Infectious Diseases, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
name: José Marcó del Pont, Physician
role: STUDY_CHAIR
affiliation: Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
name: Juan Pekolj, Doctor
role: STUDY_CHAIR
affiliation: Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
name: Eduardo de Santibañes, Doctor
role: STUDY_CHAIR
affiliation: Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
name: Martin de Santibañes, Physician
role: STUDY_DIRECTOR
References: