Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

NCT03490461 | Completed

• 1 other identifier: 4-2017-0942
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Statin group

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

Drug: Statin

Non-statin group

the administration of statins for less than 30 days after liver transplantation

Interventions

Statin DRUG

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

Statin group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 6, 2018
• Study Start: November 22, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)