Zhejiang UniversityNCT06359496
Split or Whole Liver Transplantation? A Multicenter Retrospective Cohort Study of Patients With Benign and Malignant Liver Disease
An observational study of Zhejiang University, run by Zhejiang University at 1 site in China.
Trial summary
The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Zhejiang University
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2024to 2 Apr 2024
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Each organ donation and transplantation strictly followed the guidelines of the Ethics Committee of the two hospitals, the current regulation of the Chinese Government and the Declaration of Helsinki. Every precaution has been taken to protect the privacy of research subjects and the confidentiality of their personal information. Informed consent was obtained from all patients.
Who may be able to join
- ≥ 18 years old
- Received a liver transplantation between 2018 and 2022 (3) Liver transplantation was performed by SLT or WLT
Who cannot join
- Re-LT
- Multiorgan transplantation
- Survival≤one week after LT
- Incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .
Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.
This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05.
Read the detailed description
The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .
Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.
This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05.
- Conditions
- Zhejiang University
- Being tested
- No intervention factor
- Keywords
- liver transplantation; propensity score matching; split; whole; hepatocellular carcinoma; prognosis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention factorOther
No intervention factor
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications were evaluated by postoperative imaging reports and serological indicators
Including rejection, emerging metabolic diseases, infections
Measured: Jan.1 2018-Dec.31 2022
The survival rate of each group was evaluated by follow-up survey and K-M curve
Including overall survival rate and/or tumor free survival rate
Measured: Jan.1 2018-Dec.31 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start23 Feb 2024
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zhejiang UniversityStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359496
- Sponsor's protocol ID
- CT2024-ZJU-OBS8
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: baseline characters of patients.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split or Whole Liver Transplantation? A Multicenter Retrospective Cohort Study of Patients With Benign and Malignant Liver Disease
- ClinicalTrials.gov ID
- NCT06359496
- Acronym / sponsor ID
- CT2024-ZJU-OBS8
- Conditions
- Zhejiang University
- Keywords
- liver transplantation; propensity score matching; split; whole; hepatocellular carcinoma; prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 11 Apr 2024 (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 primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .
Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.
This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05.
Detailed description
The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .
Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.
This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Each organ donation and transplantation strictly followed the guidelines of the Ethics Committee of the two hospitals, the current regulation of the Chinese Government and the Declaration of Helsinki. Every precaution has been taken to protect the privacy of research subjects and the confidentiality of their personal information. Informed consent was obtained from all patients.
Key inclusion criteria (2 listed)
- ≥ 18 years old
- Received a liver transplantation between 2018 and 2022 (3) Liver transplantation was performed by SLT or WLT
Key exclusion criteria (4 listed)
- Re-LT
- Multiorgan transplantation
- Survival≤one week after LT
- Incomplete data
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 intervention factorNo intervention factor | Other | – |
Primary outcome
Postoperative complications were evaluated by postoperative imaging reports and serological indicators
Time frame: Jan.1 2018-Dec.31 2022
Including rejection, emerging metabolic diseases, infections
The survival rate of each group was evaluated by follow-up survey and K-M curve
Time frame: Jan.1 2018-Dec.31 2022
Including overall survival rate and/or tumor free survival rate
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 11 Apr 2024.
- Individual participant dataSharing planned: Yes. baseline characters of patients.
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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 Zhejiang University, run by Zhejiang University 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 2 inclusion and 4 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 11 Apr 2024. 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?
Postoperative complications were evaluated by postoperative imaging reports and serological indicators (time frame: Jan.1 2018-Dec.31 2022). The study lists 2 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 11 Apr 2024.