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Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490461
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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
Hepatocellular Carcinoma Drug: Statin

Study Design
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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 : November 22, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. A new lesion with radiographic features compatible with HCC was defined as recurrence of HCC. [ Time Frame: 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
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who received LT at the Severance Hospital from 2006 to 2016.
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490461


Locations
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Korea, Republic of
Division of Endocrinology and Metabolism Department of Internal Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03490461    
Other Study ID Numbers: 4-2017-0942
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes