Association Between Pre-op Non-Selective Beta-Blockers and Hepatocellular Carcinoma Recurrence Post-Liver Transplant

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06233708
• Other study ID #: 2023-0713
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: May 31, 2022

Study information

• Verified date: January 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2092
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Hepatocellular Carcinoma Recurrent
• Recurrence

Intervention

Drug:
• Non-Selective Beta-Adrenoreceptor Agonists for Systemic Use
Non-selective blocker including Propranolol, Carvedilol PO was prescribed

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Korea Health Industry Development Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 5-year follow-up
Primary	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.	Baseline and 5-year follow-up
Secondary	Kaplan-Meier survival analysis of overall survival at 5-year follow-up	Overall survival was collected and compared using Kaplan-Meier survival analysis.	Baseline and 5-year follow-up
Secondary	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.	Baseline and 5-year follow-up