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

Completed

• Conditions: Low-weight Children; Liver Transplantation; Hyper-reduced Liver Grafts
• Interventions: Procedure: Liver transplantation with hyper-reduced grafts

• Registration Number: NCT03594864
• Lead Sponsor: Hospital Italiano de Buenos Aires

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-21
• Primary Completion: 2018-06-03
• Study Completion: 2018-06-03
• Study First Submitted: 2018-06-16
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-19
• Last Update Submitted: 2018-07-19
• Study First Posted: 2018-07-20
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyper-reduced liver recipients.	Liver transplantation with hyper-reduced grafts	Low-weight children who underwent live donor liver transplantation with ultrasound-guided in situ left lateral segment graft hyper-reduction.

Primary Outcome Measures

Name	Time	Method
Overall survival at 3 years.	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 at 1 year.	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.
Graft survival at 10 years.	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.
Overall survival at 10 years.	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.
Graft survival at 3 years.	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 at 1 year.	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.

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Capital Federal, Argentina