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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Statin

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Division of Endocrinology and Metabolism Department of Internal Medicine, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Statin group; Statin therapy was defined as the administration of statins for more than 30 days after liver transplantation	Drug: Statin; Patients who used statins over 1 month for the treatment of dyslipidemia after LT were enrolled as statin group.
Non-statin group; the administration of statins for less than 30 days after liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A new lesion with radiographic features compatible with HCC was defined as recurrence of HCC.	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.	up to December, 2017

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Recurrence
• Other Study ID Numbers: 4-2017-0942

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