Hepatocellular Carcinoma (HCC)NCT06683820
Triple Recipient Strategy Using Split, Domino, and Auxiliary Techniques
An observational study of Hepatocellular Carcinoma (HCC), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The investigators report a case of the simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) to achieve "one donor for three recipients". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2023to 2 Apr 2024
- How long will I take part?
- 1 Year
- 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: Recipient 1 was a 57-year-old female who was admitted due to hepatitis C virus-related liver cirrhosis. Recipient 2 was a 13-year-old male diagnosed with argininemia, who had a Model for End-Stage Liver Disease score of 12. Recipient 3, a 70-year-old adult male, was diagnosed with HCC and had no prior history of cirrhosis.
Who may be able to join
- liver cirrhosis
- argininemia
- hepatocellular carcinoma
Who cannot join
- Patients who do not require an allogeneic liver transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site
2ndAffiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Expanding Donor Liver Utilization: a Case Series Study of Triple Recipient Strategy Using Split, Domino, and Auxiliary Techniques.
The investigators report a case of the simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) to achieve "one donor for three recipients".
Read the detailed description
The investigators report a case of the simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) to achieve "one donor for three recipients". Three recipients had hepatitis C cirrhosis, argininemia, and hepatocellular carcinoma (HCC), respectively. The investigators performed SLT in the first two recipients (an adult and a child), with the donor liver coming from a female who died of severe head trauma. The right lobe of the child, as the "domino liver graft", was transplanted to the postoperative HCC patient, whose left lateral lobe was preserved after tumor resection. All recipients were discharged from the hospital. During the 12 months of follow-up, all three recipients remained alive.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Split liver transplantation, Domino liver transplantation, Auxiliary liver transplantation, Argininemia, Cirrhosis, Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular, Hyperargininemia, Fibrosis
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 |
|---|---|---|
| Triple Recipient Strategy | The simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative survival time
The duration of time a patient survives after undergoing a surgical procedure.
Measured: 2023/04-2024/04
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start2 Apr 2023
- 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 Hepatocellular Carcinoma (HCC)Studies 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
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683820
- Sponsor's protocol ID
- 2023-0817
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patient information is personal
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Donor Liver Utilization: a Case Series Study of Triple Recipient Strategy Using Split, Domino, and Auxiliary Techniques.
- ClinicalTrials.gov ID
- NCT06683820
- Acronym / sponsor ID
- 2023-0817
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Split liver transplantation, Domino liver transplantation, Auxiliary liver transplantation, Argininemia, Cirrhosis, Hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 12 Nov 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 investigators report a case of the simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) to achieve "one donor for three recipients".
Detailed description
The investigators report a case of the simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) to achieve "one donor for three recipients". Three recipients had hepatitis C cirrhosis, argininemia, and hepatocellular carcinoma (HCC), respectively. The investigators performed SLT in the first two recipients (an adult and a child), with the donor liver coming from a female who died of severe head trauma. The right lobe of the child, as the "domino liver graft", was transplanted to the postoperative HCC patient, whose left lateral lobe was preserved after tumor resection. All recipients were discharged from the hospital. During the 12 months of follow-up, all three recipients remained alive.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple Recipient Strategy | – | –The simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Recipient 1 was a 57-year-old female who was admitted due to hepatitis C virus-related liver cirrhosis. Recipient 2 was a 13-year-old male diagnosed with argininemia, who had a Model for End-Stage Liver Disease score of 12. Recipient 3, a 70-year-old adult male, was diagnosed with HCC and had no prior history of cirrhosis.
Key inclusion criteria (3 listed)
- liver cirrhosis
- argininemia
- hepatocellular carcinoma
Key exclusion criteria (1 listed)
- Patients who do not require an allogeneic liver transplantation.
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
Postoperative survival time
Time frame: 2023/04-2024/04
The duration of time a patient survives after undergoing a surgical procedure.
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 5 Dec 2024.
- Individual participant dataSharing planned: Undecided. Patient information is personal
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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 Hepatocellular Carcinoma (HCC), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 1 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 5 Dec 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 survival time (time frame: 2023/04-2024/04). 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 5 Dec 2024.