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NCT06114251 Clinical Trial

Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma

Liver Transplant; Complications Clinical Trial

Official title:
Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06114251
Other study ID # CT2023-ZJU-OBS2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date June 1, 2023

Study information
Verified date October 2023
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Highly active hepatitis B virus (HBV) is known to be associated with poor outcomes in patients with hepatocellular carcinoma (HCC). This study aims to investigate the relationship between HBV status and HCC recurrence after liver transplantation. The study retrospectively analyzed HCC patients undergoing liver transplantation in 2 centers between January 2015 and December 2020. We reviewed post-transplant HBV status and its association with outcomes.

Recruitment information / eligibility
Status Completed
Enrollment 920
Est. completion date June 1, 2023
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - (1) preoperative diagnosis of HBV-related HCC and (2) pathologically confirmed HCC. Exclusion criteria - (1) non-HBV-related HCC; (2) simultaneous presence of other tumors; (3) re-transplantation; (4) presence of portal vein tumor thrombus; and (5) a survival time of less than 90 days.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Diagnosis of postoperative recurrence of liver cancer
HBV serological markers, such as hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg) and HBV DNA were monitored regularly. The alpha-fetoprotein (AFP) level was determined every 1-2 months. The ultrasound or computed tomography or magnetic resonance imaging was performed every 3-6 months in HCC patients who underwent liver transplantation.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang University

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative recurrence of liver cancer 2015.1.1-2020.12.31
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