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

NCT06233708 | Completed

• 1 other identifier: 2023-0713
• Study Type: observational
• Target: 2,092
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatocellular Carcinoma Recurrent; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Kaplan-Meier survival analysis of overall survival at 5-year follow-up

  Baseline and 5-year follow-up

• Multivariate Cox regression analysis of overall survival at 5-year follow-up

  Baseline and 5-year follow-up

Study Arms (2)

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.

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.

Interventions

Non-Selective Beta-Adrenoreceptor Agonists for Systemic Use DRUG

Non-selective blocker including Propranolol, Carvedilol PO was prescribed

NSBB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients
• Underwent liver transplantation for treating hepatocellular carcinoma
• Between Jan. 2008 - May. 2022

You may not qualify if:

• Pediatric patients (Age under 18 years)
• Re-transplantation
• Multi-organ transplantation

Sponsors & Collaborators

• Asan Medical Center: lead
• Korea Health Industry Development Institute: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jun-Gol Song, MD, PhD

  Department of Anesthesiology and Pain Medicine, Asan Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 31, 2024
• Study Start: January 1, 2008
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share