Liver TransplantationNCT06925828
Application of in Vivo Splitting Technique in Adult Liver Transplantation
An observational study of Liver Transplantation, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
Trial summary
The feasibility of split liver transplantation (SLT) remains controversial. This study aimed to evaluate the outcomes of SLT in adult recipients and to identify specific areas of improvements. A retrospective analysis was conducted on adults who underwent full size SLT between January 2021 and December 2023. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Liver Transplantation
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult recipients who underwent SLT or WLT
Who may be able to join
- For the donor graft:
- age of 18-60 years;
- BMI of 19-28 kg/m2;
- hemodynamic stability or use of a single vasoactive drug with a small dosage (norepinephrine ≤ 0.1 μg/kg/min or dopamine ≤ 5 μg/kg/min);
- liver steatosis ≤ 10%;
- liver functional indicators (ALT, AST, total bilirubin quantification) ≤ 3 times the normal value;
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- blood sodium ≤ 160 mmol/L;
- For the SLT recipients
- Patients who had registered in the China Organ Transplant Response Systems.
- Initial liver transplantation.
- Graft-to-Recipient Weight Ratio (GRWR) ≥ 1%.
Who cannot join
- For the donor graft
- uncontrollable infection
- significant vascular and biliary variation.
- For the recipients
- Severe portal hypertension.
- Significant vascular variation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of in Vivo Splitting Technique of Brain-dead Donor Liver in Adult Liver Transplantation
The feasibility of split liver transplantation (SLT) remains controversial. This study aimed to evaluate the outcomes of SLT in adult recipients and to identify specific areas of improvements. A retrospective analysis was conducted on adults who underwent full size SLT between January 2021 and December 2023. The short-term outcomes of these patients who underwent SLT were compared with those of patients who underwent whole liver transplantation (WLT) during the same period.
- Conditions
- Liver Transplantation
- Being tested
- No intervention
- Keywords
- Split liver transplantation, Whole liver transplantation, Short-term Outcomes, Surgical complications, Morbidity and Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| SLT group | Adult recipients who underwent split liver transplantation Receives: Other: No intervention | |
| WLT group | Adult recipients who underwent whole liver transplantation Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
the overall survival of liver transplant recipient during study period
Measured: 2021.01.01-2025.12.31
Secondary outcomes (1)
Postoperative complications
Postoperative complications of liver transplant recipient during study period
Measured: 2021.01.01-2025.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, lucaide, Ningbo Medical Center Lihuili Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925828
- Sponsor's protocol ID
- CT2025-LHL-OBS1
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of in Vivo Splitting Technique of Brain-dead Donor Liver in Adult Liver Transplantation
- ClinicalTrials.gov ID
- NCT06925828
- Acronym / sponsor ID
- CT2025-LHL-OBS1
- Conditions
- Liver Transplantation
- Keywords
- Split liver transplantation, Whole liver transplantation, Short-term Outcomes, Surgical complications, Morbidity and Mortality
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Apr 2025 (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 feasibility of split liver transplantation (SLT) remains controversial. This study aimed to evaluate the outcomes of SLT in adult recipients and to identify specific areas of improvements. A retrospective analysis was conducted on adults who underwent full size SLT between January 2021 and December 2023. The short-term outcomes of these patients who underwent SLT were compared with those of patients who underwent whole liver transplantation (WLT) during the same period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLT group | – | Other: No interventionAdult recipients who underwent split liver transplantation |
| WLT group | – | Other: No interventionAdult recipients who underwent whole liver transplantation |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult recipients who underwent SLT or WLT
Key inclusion criteria (11 listed)
- For the donor graft:
- For the SLT recipients
- Patients who had registered in the China Organ Transplant Response Systems.
- Initial liver transplantation.
- Graft-to-Recipient Weight Ratio (GRWR) ≥ 1%.
Key exclusion criteria (6 listed)
- For the donor graft
- For the recipients
- Severe portal hypertension.
- Significant vascular variation.
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 |
|---|---|---|
| No interventionNo intervention | Other | SLT group, WLT group |
Primary outcome
Overall survival
Time frame: 2021.01.01-2025.12.31
the overall survival of liver transplant recipient during study period
1 secondary outcome
Postoperative complications
Time frame: 2021.01.01-2025.12.31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
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 11 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: 2021.01.01-2025.12.31). 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 13 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.