Liver TransplantationNCT07275008
Rejection After Auxiliary Partial Orthotopic Liver Transplantation: An Exploratory Comparison by Native-Liver Cirrhosis Status
An observational study of Liver Transplantation and Auxiliary Liver Transplantation, run by Zhi-Jun Zhu at 1 site in China.
Trial summary
This retrospective single-center cohort study aims to investigate the association between native-liver cirrhosis status and post-transplant outcomes in recipients undergoing auxiliary partial orthotopic liver transplantation (APOLT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplantation, Auxiliary Liver Transplantation
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consisted of recipients who underwent auxiliary partial orthotopic liver transplantation (APOLT) at Beijing Friendship Hospital, Capital Medical University, between 2014 and 2025. The final cohort included 44 eligible recipients, comprising 11 patients with non-cirrhotic native livers and 33 patients with cirrhotic native livers. Native-liver cirrhosis status was determined by histopathological examination of native-liver tissue obtained during the initial APOLT procedure. Clinical characteristics, operative data, rejection events, postoperative complications, and survival outcomes were retrospectively collected from medical records. Follow-up was censored in July 2026.
Who may be able to join
- Recipients who underwent auxiliary partial orthotopic liver transplantation (APOLT) at Beijing Friendship Hospital, Capital Medical University, between 2014 and 2025.
- Patients with a confirmed underlying liver disease.
- Patients without a history of previous solid-organ transplantation.
- Patients with available histopathological examination of native-liver tissue obtained during the initial APOLT procedure, allowing classification of native-liver cirrhosis status.
- Patients with sufficient clinical records and follow-up information to establish baseline characteristics, operative variables, and the occurrence and timing of the primary outcome or the applicable censoring time.
Who cannot join
- Patients who underwent APOLT for acute or subacute liver failure.
- Patients with idiopathic portal hypertension without histopathological evidence of cirrhosis.
- Patients with insufficient clinical or follow-up data to determine eligibility, classify native-liver cirrhosis status, or assess the primary outcome.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
This retrospective single-center cohort study aims to investigate the association between native-liver cirrhosis status and post-transplant outcomes in recipients undergoing auxiliary partial orthotopic liver transplantation (APOLT). A total of 44 recipients who underwent APOLT between 2014 and 2025 will be included and classified into non-cirrhotic and cirrhotic groups according to the histopathological findings of the retained native liver. The study will compare biopsy-proven rejection, including first and recurrent rejection episodes, postoperative complications, overall survival, and graft survival between the two groups. The findings may help improve understanding of the relationship between native-liver cirrhosis status and post-transplant outcomes and provide evidence for future clinical research and individualized post-transplant management.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-cirrhotic native liver | Recipients undergoing APOLT whose retained native liver showed no histopathological evidence of cirrhosis. A total of 11 recipients were included in this cohort. Outcomes were assessed retrospectively based on medical records, including biopsy-proven rejection, postoperative complications, overall survival, and graft survival. | |
| Cirrhotic native liver | Recipients undergoing APOLT whose retained native liver showed histopathological evidence of cirrhosis. A total of 33 recipients were included in this cohort. Outcomes were assessed retrospectively based on medical records, including biopsy-proven rejection, postoperative complications, overall survival, and graft survival. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of first biopsy-proven rejection
Occurrence of first biopsy-proven rejection after APOLT. The cumulative incidence was estimated using the Aalen-Johansen method, treating death or graft loss before first rejection as competing events.
Measured: From APOLT to first biopsy-proven rejection, death, graft loss, or last follow-up (through July 2026).
Secondary outcomes (3)
Postoperative vascular complications
Vascular, biliary and severe postoperative complications
Measured: Within one year after liver transplantation From APOLT to the last available follow-up (through July 2026).
Graft survival
Graft survival was defined as the time from APOLT to graft loss. Recipients without graft loss were censored at the date of last follow-up. Graft survival was estimated using the Kaplan-Meier method and compared between non-cirrhotic and cirrhotic recipients.
Measured: From APOLT to graft loss or the last available follow-up (through July 2026).
Overall survival
Overall survival was defined as the time from APOLT to death from any cause. Recipients who remained alive were censored at the date of last follow-up. Overall survival was estimated using the Kaplan-Meier method and compared between non-cirrhotic and cirrhotic recipients.
Measured: From APOLT to death or the last available follow-up (through July 2026).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Dec 2025
- Primary completion30 Apr 2026
- Study completion30 Jun 2026
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhi-Jun Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhi-Jun Zhu, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275008
- Sponsor's protocol ID
- BFH20251127004
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 2 Nov 2026
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rejection After Auxiliary Partial Orthotopic Liver Transplantation: An Exploratory Comparison by Native-Liver Cirrhosis Status
- ClinicalTrials.gov ID
- NCT07275008
- Acronym / sponsor ID
- BFH20251127004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Zhi-Jun ZhuUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 10 Dec 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.
This retrospective single-center cohort study aims to investigate the association between native-liver cirrhosis status and post-transplant outcomes in recipients undergoing auxiliary partial orthotopic liver transplantation (APOLT). A total of 44 recipients who underwent APOLT between 2014 and 2025 will be included and classified into non-cirrhotic and cirrhotic groups according to the histopathological findings of the retained native liver. The study will compare biopsy-proven rejection, including first and recurrent rejection episodes, postoperative complications, overall survival, and graft survival between the two groups. The findings may help improve understanding of the relationship between native-liver cirrhosis status and post-transplant outcomes and provide evidence for future clinical research and individualized post-transplant management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-cirrhotic native liver | – | –Recipients undergoing APOLT whose retained native liver showed no histopathological evidence of cirrhosis. A total of 11 recipients were included in this cohort. Outcomes were assessed retrospectively based on medical records, including biopsy-proven rejection, postoperative complications, overall survival, and graft survival. |
| Cirrhotic native liver | – | –Recipients undergoing APOLT whose retained native liver showed histopathological evidence of cirrhosis. A total of 33 recipients were included in this cohort. Outcomes were assessed retrospectively based on medical records, including biopsy-proven rejection, postoperative complications, overall survival, and graft survival. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consisted of recipients who underwent auxiliary partial orthotopic liver transplantation (APOLT) at Beijing Friendship Hospital, Capital Medical University, between 2014 and 2025. The final cohort included 44 eligible recipients, comprising 11 patients with non-cirrhotic native livers and 33 patients with cirrhotic native livers. Native-liver cirrhosis status was determined by histopathological examination of native-liver tissue obtained during the initial APOLT procedure. Clinical characteristics, operative data, rejection events, postoperative complications, and survival outcomes were retrospectively collected from medical records. Follow-up was censored in July 2026.
Key inclusion criteria (5 listed)
- Recipients who underwent auxiliary partial orthotopic liver transplantation (APOLT) at Beijing Friendship Hospital, Capital Medical University, between 2014 and 2025.
- Patients with a confirmed underlying liver disease.
- Patients without a history of previous solid-organ transplantation.
- Patients with available histopathological examination of native-liver tissue obtained during the initial APOLT procedure, allowing classification of native-liver cirrhosis status.
- Patients with sufficient clinical records and follow-up information to establish baseline characteristics, operative variables, and the occurrence and timing of the primary outcome or the applicable censoring time.
Key exclusion criteria (3 listed)
- Patients who underwent APOLT for acute or subacute liver failure.
- Patients with idiopathic portal hypertension without histopathological evidence of cirrhosis.
- Patients with insufficient clinical or follow-up data to determine eligibility, classify native-liver cirrhosis status, or assess the primary outcome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative incidence of first biopsy-proven rejection
Time frame: From APOLT to first biopsy-proven rejection, death, graft loss, or last follow-up (through July 2026).
Occurrence of first biopsy-proven rejection after APOLT. The cumulative incidence was estimated using the Aalen-Johansen method, treating death or graft loss before first rejection as competing events.
3 secondary outcomes
Postoperative vascular complications
Time frame: Within one year after liver transplantation From APOLT to the last available follow-up (through July 2026).
Graft survival
Time frame: From APOLT to graft loss or the last available follow-up (through July 2026).
Overall survival
Time frame: From APOLT to death or the last available follow-up (through July 2026).
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 2 Nov 2026.
- 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 and Auxiliary Liver Transplantation, run by Zhi-Jun Zhu 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 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 2 Nov 2026. 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?
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?
Cumulative incidence of first biopsy-proven rejection (time frame: From APOLT to first biopsy-proven rejection, death, graft loss, or last follow-up (through July 2026).). 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 2 Nov 2026.