Liver TransplantationNCT03594864
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
An observational study of Liver Transplantation and Low-weight Children, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 5 months to 17 years
- Conditions the study is for
- Liver Transplantation, Low-weight Children, Hyper-reduced Liver Grafts
- What is being tested?
- Liver transplantation with hyper-reduced grafts
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteArgentina
- Study dates
- 21 Apr 2018to 3 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months to 17 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- < 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
Who cannot join
- > 17 years old.
- Cadaveric liver transplant
- Whole liver grafts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Liver transplantation with hyper-reduced grafts
- Keywords
- Liver, Transplantation, Hyper-reduction, Graft survival, Overall survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantation with hyper-reduced graftsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyper-reduced liver recipients. | Low-weight children who underwent live donor liver transplantation with ultrasound-guided in situ left lateral segment graft hyper-reduction. Receives: Procedure: Liver transplantation with hyper-reduced grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Overall survival wil be reported at 1 year after liver transplantation.
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.
Measured: Overall survival wil be reported at 3 years after liver transplantation.
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.
Measured: Overall survival wil be reported at 10 years after liver transplantation.
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.
Measured: Graft survival wil be reported at 1 year after liver transplantation.
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.
Measured: Graft survival wil be reported at 3 years after liver transplantation.
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.
Measured: Graft survival wil be reported at 10 years after liver transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start21 Apr 2018
- Primary completion3 Jun 2018
- Study completion3 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MICAELA RAICES, Hospital Italiano de Buenos Aires
- Investigators
- Micaela Raices, Physician, Principal investigator, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.Matias E Czerwonko, Physician, Study chair, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.Victoria Ardiles, Physician, Study chair, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.Gustavo Boldrini, Physician, Study chair, Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.Daniel D'Agostino, Physician, Study chair, Department of Pediatrics, Division of Pediatric Gastroenterology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.José Marcó del Pont, Physician, Study chair, Department of Pediatrics, Division of Pediatric Infectious Diseases, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.Juan Pekolj, Doctor, Study chair, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.Eduardo de Santibañes, Doctor, Study chair, Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594864
- Sponsor's protocol ID
- 321654
- Status last verified
- Jul 2018
- First submitted
- 16 Jun 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-term Outcomes After Transplantation With Hyper-reduced Liver Grafts in Low-Weight Pediatric Recipients
- ClinicalTrials.gov ID
- NCT03594864
- Acronym / sponsor ID
- 321654
- Keywords
- Liver, Transplantation, Hyper-reduction, Graft survival, Overall survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 21 Apr 2018 (actual)
- Primary completion
- 3 Jun 2018 (actual)
- Study completion
- 3 Jun 2018 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyper-reduced liver recipients. | – | Procedure: Liver transplantation with hyper-reduced graftsLow-weight children who underwent live donor liver transplantation with ultrasound-guided in situ left lateral segment graft hyper-reduction. |
Who may qualify
- Ages
- 5 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (5 listed)
- < 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
Key exclusion criteria (3 listed)
- > 17 years old.
- Cadaveric liver transplant
- Whole liver grafts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantation with hyper-reduced graftsLive 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. | Procedure or surgery | Hyper-reduced liver recipients. |
Primary outcome
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 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 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.
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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micaela Raices, Physician principal investigator
Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Matias E Czerwonko, Physician study chair
Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Victoria Ardiles, Physician study chair
Department of General Surgery, Division of HPB Surgery and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Low-weight Children, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival at 1 year. (time frame: Overall survival wil be reported at 1 year after liver transplantation.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.