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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594864
• Other study ID #: 321654
• Status: Completed
• Start date: April 21, 2018
• Est. completion date: June 3, 2018

Study information

• Verified date: July 2018
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 3, 2018
• Est. primary completion date: June 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Hyper-reduced Liver Grafts
• Liver Transplantation
• Low-weight Children

Intervention

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.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Capital Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival at 1 year.	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.
Primary	Overall survival at 3 years.	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.
Primary	Overall survival at 10 years.	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.
Primary	Graft survival at 1 year.	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.
Primary	Graft survival at 3 years.	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.
Primary	Graft survival at 10 years.	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.