Liver DiseasesNCT05018741
Prognostic Factors After Liver Transplantation
An observational study of Liver Diseases and Liver Transplant; Complications, run by Changhua Christian Hospital.
Trial summary
The study retrospectively reviewed the medical records of patients who received adult liver transplantation in Changhua Christian hospital from 2002 to 2019. We collected their personal data about liver disease, laboratory data about liver function, pre-transplant evaluation and post-transplant outcome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Diseases, Liver Transplant; Complications
- What is being tested?
- liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2002to 31 Dec 2019
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients with acute liver failure or chronic liver disease due to different etiologies received liver transplantation
Who may be able to join
- patients who received adult liver transplantation in Changhua Christian hospital from 2002 to 2019
Who cannot join
- patients who did not have suitable donor for liver transplantation
About this study
The study retrospectively reviewed the medical records of patients who received adult liver transplantation in Changhua Christian hospital from 2002 to 2019. We collected their personal data about liver disease, laboratory data about liver function, pre-transplant evaluation and post-transplant outcome. We investigate what prognostic factors may contribute a good survival outcome, and improve our clinical practice.
- Conditions
- Liver Diseases, Liver Transplant; Complications
- Being tested
- liver transplantation
- Keywords
- liver transplantation, chronic liver disease, viral hepatitis, alcoholic liver disease
- Medical subject headings
- Liver Diseases, Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver transplantationProcedure or surgery
liver transplantation for chronic liver disease or acute liver failure
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant | Not described Receives: Procedure: liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with morbidity and mortality after surgery
post-operative complications which requiring interventions, related to organ failure and hospital mortality
Measured: upto one month after surgery
Secondary outcomes (1)
long-term survival rate
1,5 year survival rate
Measured: upto 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Jan 2002
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao-Li Chen, Study chair, Department of General Surgery, Changhua Christian Hospital, Changhua, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018741
- Sponsor's protocol ID
- 191244
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SG, Hwang S, Moon DB, Ahn CS, Kim KH, Sung KB, Ko GY, Park KM, Ha TY, Song GW. Expanded indication criteria of living donor liver transplantation for hepatocellular carcinoma at one large-volume center. Liver Transpl. 2008 Jul;14(7):935-45. doi: 10.1002/lt.21445.
PubMed 18581465Chang Y, Cho Y, Lee JH, Lee YB, Cho EJ, Yu SJ, Sinn DH, Kim BH, Kim SH, Yi NJ, Lee KW, Kim JM, Park JW, Kim YJ, Yoon JH, Joh JW, Suh KS. Comparison of Models for Tumor Recurrence after Liver Transplantation for the Patients with Hepatocellular Carcinoma: A Multicenter Long-Term Follow-Up Study. Cancers (Basel). 2019 Sep 3;11(9):1295. doi: 10.3390/cancers11091295.
PubMed 31484287Mazzaferro V, Llovet JM, Miceli R, Bhoori S, Schiavo M, Mariani L, Camerini T, Roayaie S, Schwartz ME, Grazi GL, Adam R, Neuhaus P, Salizzoni M, Bruix J, Forner A, De Carlis L, Cillo U, Burroughs AK, Troisi R, Rossi M, Gerunda GE, Lerut J, Belghiti J, Boin I, Gugenheim J, Rochling F, Van Hoek B, Majno P; Metroticket Investigator Study Group. Predicting survival after liver transplantation in patients with hepatocellular carcinoma beyond the Milan criteria: a retrospective, exploratory analysis. Lancet Oncol. 2009 Jan;10(1):35-43. doi: 10.1016/S1470-2045(08)70284-5. Epub 2008 Dec 4.
PubMed 19058754
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors After Liver Transplantation
- ClinicalTrials.gov ID
- NCT05018741
- Acronym / sponsor ID
- 191244
- Conditions
- Liver Diseases, Liver Transplant; Complications
- Keywords
- liver transplantation, chronic liver disease, viral hepatitis, alcoholic liver disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Aug 2021 (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 study retrospectively reviewed the medical records of patients who received adult liver transplantation in Changhua Christian hospital from 2002 to 2019. We collected their personal data about liver disease, laboratory data about liver function, pre-transplant evaluation and post-transplant outcome. We investigate what prognostic factors may contribute a good survival outcome, and improve our clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant | – | Procedure: liver transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with acute liver failure or chronic liver disease due to different etiologies received liver transplantation
Key inclusion criteria (1 listed)
- patients who received adult liver transplantation in Changhua Christian hospital from 2002 to 2019
Key exclusion criteria (1 listed)
- patients who did not have suitable donor for 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver transplantationliver transplantation for chronic liver disease or acute liver failure | Procedure or surgery | Liver transplant |
Primary outcome
number of participants with morbidity and mortality after surgery
Time frame: upto one month after surgery
post-operative complications which requiring interventions, related to organ failure and hospital mortality
1 secondary outcome
long-term survival rate
Time frame: upto 5 years after surgery
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 24 Aug 2021.
- Background: PubMed 18581465Lee SG, Hwang S, Moon DB, Ahn CS, Kim KH, Sung KB, Ko GY, Park KM, Ha TY, Song GW. Expanded indication criteria of living donor liver transplantation for hepatocellular carcinoma at one large-volume center. Liver Transpl. 2008 Jul;14(7):935-45. doi: 10.1002/lt.21445.
- Background: PubMed 31484287Chang Y, Cho Y, Lee JH, Lee YB, Cho EJ, Yu SJ, Sinn DH, Kim BH, Kim SH, Yi NJ, Lee KW, Kim JM, Park JW, Kim YJ, Yoon JH, Joh JW, Suh KS. Comparison of Models for Tumor Recurrence after Liver Transplantation for the Patients with Hepatocellular Carcinoma: A Multicenter Long-Term Follow-Up Study. Cancers (Basel). 2019 Sep 3;11(9):1295. doi: 10.3390/cancers11091295.
- Results publication: PubMed 19058754Mazzaferro V, Llovet JM, Miceli R, Bhoori S, Schiavo M, Mariani L, Camerini T, Roayaie S, Schwartz ME, Grazi GL, Adam R, Neuhaus P, Salizzoni M, Bruix J, Forner A, De Carlis L, Cillo U, Burroughs AK, Troisi R, Rossi M, Gerunda GE, Lerut J, Belghiti J, Boin I, Gugenheim J, Rochling F, Van Hoek B, Majno P; Metroticket Investigator Study Group. Predicting survival after liver transplantation in patients with hepatocellular carcinoma beyond the Milan criteria: a retrospective, exploratory analysis. Lancet Oncol. 2009 Jan;10(1):35-43. doi: 10.1016/S1470-2045(08)70284-5. Epub 2008 Dec 4.
- 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.
Yao-Li Chen study chair
Department of General Surgery, Changhua Christian Hospital, Changhua, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Liver Transplant; Complications, run by Changhua Christian Hospital.
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: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
number of participants with morbidity and mortality after surgery (time frame: upto one month after surgery). 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 NCT05018741, which also lists 3 linked publications.
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 24 Aug 2021.