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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

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ClinicalTrials.gov Identifier: NCT03594864
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
MICAELA RAICES, Hospital Italiano de Buenos Aires

Study Description
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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.

Condition or disease Intervention/treatment
Liver Transplantation Low-weight Children Hyper-reduced Liver Grafts Procedure: Liver transplantation with hyper-reduced grafts

Study Design
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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Short and Long-term Outcomes After Transplantation With Hyper-reduced Liver Grafts in Low-Weight Pediatric Recipients
Actual Study Start Date : April 21, 2018
Actual Primary Completion Date : June 3, 2018
Actual Study Completion Date : June 3, 2018

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Hyper-reduced liver recipients.
Low-weight children who underwent live donor liver transplantation with ultrasound-guided in situ left lateral segment graft hyper-reduction.
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   5 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594864


Locations
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Argentina
Hospital Italiano de Buenos Aires
Capital Federal, Argentina, C1100AAF
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Principal Investigator: Micaela Raices, Physician Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Study Chair: Matias E Czerwonko, Physician Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Study Chair: Victoria Ardiles, Physician Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Study Chair: Gustavo Boldrini, Physician Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Study Chair: Daniel D'Agostino, Physician Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Study Chair: José Marcó del Pont, Physician Department of Pediatrics, Division of Pediatric Infectious Diseases, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Study Chair: Juan Pekolj, Doctor Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Study Chair: Eduardo de Santibañes, Doctor Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Study Director: Martin de Santibañes, Physician Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
More Information
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Responsible Party: MICAELA RAICES, Principal Investigator, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT03594864    
Other Study ID Numbers: 321654
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Keywords provided by MICAELA RAICES, Hospital Italiano de Buenos Aires:
Liver
Transplantation
Hyper-reduction
Graft survival
Overall survival
Additional relevant MeSH terms:
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Body Weight