Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma
Sponsor
Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT06114251
Collaborator
(none)
920
101
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
920 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma
Actual Study Start Date
:
Jan 1, 2015
Actual Primary Completion Date
:
Dec 31, 2020
Actual Study Completion Date
:
Jun 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| First Affiliated Hospital, Zhejiang University School of Medicine
|
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.
|
| Shulan (Hangzhou) Hospital
|
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.
|
Outcome Measures
Primary Outcome Measures
- Postoperative recurrence of liver cancer [2015.1.1-2020.12.31]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Xiao Xu,
Professor,
Zhejiang University
ClinicalTrials.gov Identifier:
NCT06114251
Other Study ID Numbers:
- CT2023-ZJU-OBS2
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Oct 1, 2023
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: