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

July 19, 2018 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Overall survival wil be reported at 1 year after liver transplantation.
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.
Overall survival wil be reported at 3 years after liver transplantation.
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.
Overall survival wil be reported at 10 years after liver transplantation.
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.
Graft survival wil be reported at 1 year after liver transplantation.
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.
Graft survival wil be reported at 3 years after liver transplantation.
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.
Graft survival wil be reported at 10 years after liver transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2018

Primary Completion (Actual)

June 3, 2018

Study Completion (Actual)

June 3, 2018

Study Registration Dates

First Submitted

June 16, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 321654

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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