Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03490461
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Actual Duration (Months): 3.3
• Patients Per Site Per Month: 107.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Statin

Study Design

• Study Type: Observational
• Actual Enrollment: 350 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation
• Actual Study Start Date: Nov 22, 2017
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Endocrinology and Metabolism Department of Internal Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT03490461
• Other Study ID Numbers: 4-2017-0942
• First Posted: Apr 6, 2018
• Last Update Posted: Apr 6, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Recurrence

Study Results

No Results Posted as of Apr 6, 2018