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Completed

NCT Number: NCT06233708

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Selective Beta-Adrenoreceptor Agonists for Systemic Use

Drug

Non-selective blocker including Propranolol, Carvedilol PO was prescribed

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Korea Health Industry Development Institute

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2024
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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