Liver Transplant, Liver Cancer, ImmunosuppressantNCT05587556
Analysis of Clinical Outcomes and Complications in Patients Received Liver Transplantation: A Retrospective Study
An observational study of Liver Transplant, Liver Cancer, Immunosuppressant, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Liver transplantation is the last-line method for liver failure. Thomas Starzl completed the first liver transplant in 1967, liver transplantation is developing rapidly. In Taiwan, the first liver transplantation was started in 1984, and the living donor liver transplantation was started in 1994. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplant, Liver Cancer, Immunosuppressant
- How many people
- 1,400 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2022to 31 Dec 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Preoperative diagnosis, surgical status, postoperative status, presence or absence of complications, postoperative medication status, medication complications and post-recurrence treatment for patients who received liver transplantation or who were followed up after liver transplantation difference analysis
Who may be able to join
- 1400 patients who received liver transplantation or patients who were followed up after liver transplantation
Who cannot join
- Patients who do not meet the inclusion and exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Liver transplantation is the last-line method for liver failure. Thomas Starzl completed the first liver transplant in 1967, liver transplantation is developing rapidly. In Taiwan, the first liver transplantation was started in 1984, and the living donor liver transplantation was started in 1994. According to statistics from the Taiwan Organ Transplant Registration Center, from 2005 to 2018, a total of 6,211 liver transplants were completed in Taiwan, and the three-year survival rate was 78.9%.
The success rate of liver transplantation is closely related to the operation method, complications, the patient's conditions, and postoperative care. Besides, Liver cancer is the sixth most common cancer in the whole world and also the fourth leading cause of cancer-related death. Approximately 90% of patients are diagnosed with liver cirrhosis at the same time when they are diagnosed with liver cancer. Once the late stages of liver cirrhosis happen, the effect of treatment will be reduced. Therefore, liver transplantation is the only treatment option that can solve the simultaneous occurrence of liver cirrhosis and liver cancer. Since 1996, liver transplantation has been used to treat liver cancer, the organ source is always the Achilles tendon of organ transplantation. Therefore, Milan criteria was designed to achieve the justice of organ share. However, living donor liver transplant is more popular in Eastern countries because of religious factors and ethical issues and many famous medical centers are trying to expand the original Milan or UCSF criteria, such as Kyoto criteria and Up-to-7 criteria, hoping to save more patients. However, with the expansion of conditions, the chance of recurrence or metastasis after transplantation is bound to increase. According to reports from different famous medical centers, the recurrence rate of liver cancer after liver transplantation is about 10-20%.
Therefore, we assume that patients with liver replacement caused by different diseases may have other postoperative conditions and complications. This study will review the preoperative diagnosis, surgical status, postoperative status, medication status, complications and recurrence of liver transplant patients in our hospital for statistical analysis.
- Medical subject headings
- Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The survial rate of the patients
To investigate whether preoperative diagnosis, surgical status, postoperative status, medication status, complications and recurrence have significant differences in the survival rate of patients.
Measured: Jan. 2002 to Dec. 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Feb 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant, Liver Cancer, ImmunosuppressantStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long-Bin Jeng, China Medical University Hospital
- Investigators
- Long-Bin Jeng, Principal investigator, Organ Transplantation Center, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587556
- Sponsor's protocol ID
- CMUH110-REC1-235
- Status last verified
- Jan 2022
- First submitted
- 17 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsu SC, Yang HR, Chen SH, Chen TH, Hsu WF, Wang HW, Yeh CC, Lai HC, Jeng LB. Systemic Treatment Strategies for Recurrent Hepatocellular Carcinoma Following Liver Transplantation: A 20-y Retrospective Analysis With Clinical Insights. Transplantation. 2026 Jun 1;110(6):e1254-e1264. doi: 10.1097/TP.0000000000005702. Epub 2026 May 1.
PubMed 42062823
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Outcomes and Complications in Patients Received Liver Transplantation: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05587556
- Acronym / sponsor ID
- CMUH110-REC1-235
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Oct 2022 (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.
Liver transplantation is the last-line method for liver failure. Thomas Starzl completed the first liver transplant in 1967, liver transplantation is developing rapidly. In Taiwan, the first liver transplantation was started in 1984, and the living donor liver transplantation was started in 1994. According to statistics from the Taiwan Organ Transplant Registration Center, from 2005 to 2018, a total of 6,211 liver transplants were completed in Taiwan, and the three-year survival rate was 78.9%.
The success rate of liver transplantation is closely related to the operation method, complications, the patient's conditions, and postoperative care. Besides, Liver cancer is the sixth most common cancer in the whole world and also the fourth leading cause of cancer-related death. Approximately 90% of patients are diagnosed with liver cirrhosis at the same time when they are diagnosed with liver cancer. Once the late stages of liver cirrhosis happen, the effect of treatment will be reduced. Therefore, liver transplantation is the only treatment option that can solve the simultaneous occurrence of liver cirrhosis and liver cancer. Since 1996, liver transplantation has been used to treat liver cancer, the organ source is always the Achilles tendon of organ transplantation. Therefore, Milan criteria was designed to achieve the justice of organ share. However, living donor liver transplant is more popular in Eastern countries because of religious factors and ethical issues and many famous medical centers are trying to expand the original Milan or UCSF criteria, such as Kyoto criteria and Up-to-7 criteria, hoping to save more patients. However, with the expansion of conditions, the chance of recurrence or metastasis after transplantation is bound to increase. According to reports from different famous medical centers, the recurrence rate of liver cancer after liver transplantation is about 10-20%.
Therefore, we assume that patients with liver replacement caused by different diseases may have other postoperative conditions and complications. This study will review the preoperative diagnosis, surgical status, postoperative status, medication status, complications and recurrence of liver transplant patients in our hospital for statistical analysis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preoperative diagnosis, surgical status, postoperative status, presence or absence of complications, postoperative medication status, medication complications and post-recurrence treatment for patients who received liver transplantation or who were followed up after liver transplantation difference analysis
Key inclusion criteria (1 listed)
- 1400 patients who received liver transplantation or patients who were followed up after liver transplantation
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion and exclusion criteria
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
The survial rate of the patients
Time frame: Jan. 2002 to Dec. 2021
To investigate whether preoperative diagnosis, surgical status, postoperative status, medication status, complications and recurrence have significant differences in the survival rate of patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Derived from this study: PubMed 42062823Hsu SC, Yang HR, Chen SH, Chen TH, Hsu WF, Wang HW, Yeh CC, Lai HC, Jeng LB. Systemic Treatment Strategies for Recurrent Hepatocellular Carcinoma Following Liver Transplantation: A 20-y Retrospective Analysis With Clinical Insights. Transplantation. 2026 Jun 1;110(6):e1254-e1264. doi: 10.1097/TP.0000000000005702. Epub 2026 May 1.
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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.
Long-Bin Jeng principal investigator
Organ Transplantation Center, China Medical University Hospital
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 Transplant, Liver Cancer, Immunosuppressant, run by China Medical University Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 20 Oct 2022. 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 Taiwan. 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?
Results are not available in the source record.
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?
The survial rate of the patients (time frame: Jan. 2002 to Dec. 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05587556, which also lists 1 linked publication.
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 Oct 2022.