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

NCT ID: NCT06114251

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

920 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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First Affiliated Hospital, Zhejiang University School of Medicine

Diagnosis of postoperative recurrence of liver cancer

Intervention Type DIAGNOSTIC_TEST

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

Diagnosis of postoperative recurrence of liver cancer

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Xiao Xu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Li H, Lu D, Chen J, Zhang J, Zhuo J, Lin Z, Cao C, Shen W, He C, Chen H, Hu Z, Sun Y, Wei X, Zhuang L, Zheng S, Xu X. Post-transplant hepatitis B virus reactivation impacts the prognosis of patients with hepatitis B-related hepatocellular carcinoma: a dual-centre retrospective cohort study in China. Int J Surg. 2024 Apr 1;110(4):2263-2274. doi: 10.1097/JS9.0000000000001141.

Reference Type DERIVED
PMID: 38348848 (View on PubMed)

Other Identifiers

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CT2023-ZJU-OBS2

Identifier Type: -

Identifier Source: org_study_id

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