Hepatocellular Carcinoma RecurrentNCT06233708
Association Between Pre-op Non-Selective Beta-Blockers and Hepatocellular Carcinoma Recurrence Post-Liver Transplant
An observational study of Hepatocellular Carcinoma Recurrent and Hepatocellular Carcinoma, run by Asan Medical Center.
Trial summary
The goal of this observational study is to investigate the effect of non-selective beta-blocker (NSBB) on the recurrence of hepatocellular carcinoma (HCC) following liver transplantation in patients who underwent liver transplantation (LT) for treating hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma Recurrent, Hepatocellular Carcinoma
- What is being tested?
- Non-Selective Beta-Adrenoreceptor Agonists for Systemic Use
- How many people
- 2,092 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent liver transplantation at Asan Medical Center between Jan. 2008 - May 2022. Asan Medical Center is a tertiary, teaching hospital of the University of Ulsan College of Medicine, located in Seoul, South Korea.
Who may be able to join
- Adult patients
- Underwent liver transplantation for treating hepatocellular carcinoma
- Between Jan. 2008 - May. 2022
Who cannot join
- Pediatric patients (Age under 18 years)
- Re-transplantation
- Multi-organ transplantation
About this study
Official title: Association Between Pre-operative Use of Non-selective Beta-blockers With the Risk of Hepatocellular Carcinoma Recurrence Following Liver Transplantation : a Retrospective Cohort Study
The goal of this observational study is to investigate the effect of non-selective beta-blocker (NSBB) on the recurrence of hepatocellular carcinoma (HCC) following liver transplantation in patients who underwent liver transplantation (LT) for treating hepatocellular carcinoma.
The main question[s] it aims to answer are:
Read more
- Is the usage of non-selective beta-blocker associated with decreased recurrence of hepatocellular carcinoma following liver transplantation?
- Is the usage of non-selective beta-blocker associated with all-cause mortality following liver transplantation?
Researchers will compare the NSBB group, including patients who received non-selective beta-blocker therapy for at least 30 consecutive days within 3 months prior to liver transplantation more than 30 days prior, with the control group to to see if non-selective beta-blocker treatment is associated with decreased recurrence of hepatocellular carcinoma following liver transplantation.
- Being tested
- Non-Selective Beta-Adrenoreceptor Agonists for Systemic Use
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Selective Beta-Adrenoreceptor Agonists for Systemic UseDrug
Non-selective blocker including Propranolol, Carvedilol PO was prescribed
| Study group | Role | What they receive |
|---|---|---|
| NSBB group | The NSBB group was defined as those who received NSBBs for at least 30 consecutive days within the 3 months prior to LT. Receives: Drug: Non-Selective Beta-Adrenoreceptor Agonists for Systemic Use | |
| Control group | Those who did not meet the above criteria were classified as the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier survival analysis of HCC recurrence at 5-year follow-up
HCC recurrence, which was diagnosed based on pathological or radiographic evidence of new lesions consistent with HCC, and recurrence-free survival was collected and compared using Kaplan-Meier survival analysis.
Measured: Baseline and 5-year follow-up
Multivariate Cox regression analysis of HCC recurrence at 5-year follow-up
Multivariate Cox regression analysis was performed to identify the risk factors for HCC recurrence.
Measured: Baseline and 5-year follow-up
Secondary outcomes (2)
Kaplan-Meier survival analysis of overall survival at 5-year follow-up
Overall survival was collected and compared using Kaplan-Meier survival analysis.
Measured: Baseline and 5-year follow-up
Multivariate Cox regression analysis of overall survival at 5-year follow-up
Multivariate Cox regression analysis was performed to identify the risk factors for overall mortality.
Measured: Baseline and 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jan 2008
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma RecurrentStudies 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
- 2,092 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Jun-Gol Song, Asan Medical Center
- Investigators
- Jun-Gol Song, MD, PhD, Study chair, Department of Anesthesiology and Pain Medicine, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233708
- Sponsor's protocol ID
- 2023-0713
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Pre-operative Use of Non-selective Beta-blockers With the Risk of Hepatocellular Carcinoma Recurrence Following Liver Transplantation : a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06233708
- Acronym / sponsor ID
- 2023-0713
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,092 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 31 Jan 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 goal of this observational study is to investigate the effect of non-selective beta-blocker (NSBB) on the recurrence of hepatocellular carcinoma (HCC) following liver transplantation in patients who underwent liver transplantation (LT) for treating hepatocellular carcinoma.
The main question[s] it aims to answer are:
- Is the usage of non-selective beta-blocker associated with decreased recurrence of hepatocellular carcinoma following liver transplantation?
- Is the usage of non-selective beta-blocker associated with all-cause mortality following liver transplantation?
Researchers will compare the NSBB group, including patients who received non-selective beta-blocker therapy for at least 30 consecutive days within 3 months prior to liver transplantation more than 30 days prior, with the control group to to see if non-selective beta-blocker treatment is associated with decreased recurrence of hepatocellular carcinoma following liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSBB group | – | Drug: Non-Selective Beta-Adrenoreceptor Agonists for Systemic UseThe NSBB group was defined as those who received NSBBs for at least 30 consecutive days within the 3 months prior to LT. |
| Control group | – | –Those who did not meet the above criteria were classified as the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent liver transplantation at Asan Medical Center between Jan. 2008 - May 2022. Asan Medical Center is a tertiary, teaching hospital of the University of Ulsan College of Medicine, located in Seoul, South Korea.
Key inclusion criteria (3 listed)
- Adult patients
- Underwent liver transplantation for treating hepatocellular carcinoma
- Between Jan. 2008 - May. 2022
Key exclusion criteria (3 listed)
- Pediatric patients (Age under 18 years)
- Re-transplantation
- Multi-organ 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 |
|---|---|---|
| Non-Selective Beta-Adrenoreceptor Agonists for Systemic UseNon-selective blocker including Propranolol, Carvedilol PO was prescribed | Drug | NSBB group |
Primary outcome
Kaplan-Meier survival analysis of HCC recurrence at 5-year follow-up
Time frame: Baseline and 5-year follow-up
HCC recurrence, which was diagnosed based on pathological or radiographic evidence of new lesions consistent with HCC, and recurrence-free survival was collected and compared using Kaplan-Meier survival analysis.
Multivariate Cox regression analysis of HCC recurrence at 5-year follow-up
Time frame: Baseline and 5-year follow-up
Multivariate Cox regression analysis was performed to identify the risk factors for HCC recurrence.
2 secondary outcomes
Kaplan-Meier survival analysis of overall survival at 5-year follow-up
Time frame: Baseline and 5-year follow-up
Multivariate Cox regression analysis of overall survival at 5-year follow-up
Time frame: Baseline and 5-year follow-up
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 31 Jan 2024.
- 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.
Jun-Gol Song, MD, PhD study chair
Department of Anesthesiology and Pain Medicine, Asan Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Recurrent and Hepatocellular Carcinoma, run by Asan Medical Center.
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 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 31 Jan 2024. 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?
Kaplan-Meier survival analysis of HCC recurrence at 5-year follow-up (time frame: Baseline and 5-year follow-up). 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 31 Jan 2024.