Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Statin

• Registration Number: NCT03490461
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-22
• Status Verified: 2018-03
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-05
• Last Update Submitted: 2018-04-05
• Study First Posted: 2018-04-06
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Statin group	Statin	Statin therapy was defined as the administration of statins for more than 30 days after liver transplantation

Primary Outcome Measures

Name	Time	Method
A new lesion with radiographic features compatible with HCC was defined as recurrence of HCC.	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.

Trial Locations

Locations (1)

Division of Endocrinology and Metabolism Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of