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OpenTrials
Completed

NCT Number: NCT03490461

Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

This study aims to investigate whether statin therapy can help prevent recurrence of hepatocellular carcinoma (HCC) in transplant recipients who had liver transplantation for HCC. Multiple logistic regression analysis will be performed to evaluate the association between statin therapy and the risk of HCC recurrence after LT.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Endocrinology and Metabolism Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who received LT at the Severance Hospital from 2006 to 2016.

Exclusion criteria

  • early postoperative mortality (defined as death within 2 months after LT without signs of tumor recurrence)
  • patient with distant lymph node metastasis confirmed within 1 month after LT
  • Patients younger than 20 years of age
  • patients who had LT for cirrhosis without confirmed HCC

Treatment and study plan

Statin

Drug

Patients who used statins over 1 month for the treatment of dyslipidemia after LT were enrolled as statin group.

Primary outcomes

  1. A new lesion with radiographic features compatible with HCC was defined as recurrence of HCC.

    Time frame: up to December, 2017

    Usually, liver CT is performed at 1 week, 1 month, 6 months, and every year until 5 years after surgery. Afterwards, liver CT is performed at 2-year intervals. Measurement of blood tumor markers [AFP and prothrombin induced by vitamin K absence-II] is performed every month for 6 months after discharge from the hospital and every 3 months thereafter. Additional liver CT, liver magnetic resonance imaging, or positron emission tomography-CT is performed when elevated tumor markers or suspicious lesions were noted. A new lesion with radiographic features compatible with HCC is defined as recurrence of HCC based on the reports of specialist in radiology.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2018
Registry last updated
Apr 6, 2018

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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