Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

Hepatocellular Carcinoma Clinical Trial

Official title:

Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490461
• Other study ID #: 4-2017-0942
• Status: Completed
• First received: March 29, 2018
• Last updated: April 5, 2018
• Start date: November 22, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Division of Endocrinology and Metabolism Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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