Association Between Pre-op Non-Selective Beta-Blockers and Hepatocellular Carcinoma Recurrence Post-Liver Transplant
January 28, 2024 updated by: Jun-Gol Song, Asan Medical Center
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:
- 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 Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2092
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Adult patients
- Underwent liver transplantation for treating hepatocellular carcinoma
- Between Jan. 2008 - May. 2022
Exclusion Criteria:
- Pediatric patients (Age under 18 years)
- Re-transplantation
- Multi-organ transplantation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Non-selective blocker including Propranolol, Carvedilol PO was prescribed
|
|
Control group
Those who did not meet the above criteria were classified as the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 5-year follow-up
|
|
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.
|
Baseline and 5-year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kaplan-Meier survival analysis of overall survival at 5-year follow-up
Time Frame: Baseline and 5-year follow-up
|
Overall survival was collected and compared using Kaplan-Meier survival analysis.
|
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
|
Multivariate Cox regression analysis was performed to identify the risk factors for overall mortality.
|
Baseline and 5-year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Jun-Gol Song, MD, PhD, Department of Anesthesiology and Pain Medicine, Asan Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2008
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
January 19, 2024
First Submitted That Met QC Criteria
January 28, 2024
First Posted (Estimated)
January 31, 2024
Study Record Updates
Last Update Posted (Estimated)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 28, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0713
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.