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

NCT06114251 | Completed

• 1 other identifier: CT2023-ZJU-OBS2
• Study Type: observational
• Target: 920
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Postoperative recurrence of liver cancer

  2015.1.1-2020.12.31

Study Arms (2)

First Affiliated Hospital, Zhejiang University School of Medicine

Diagnostic Test: Diagnosis of postoperative recurrence of liver cancer

Shulan (Hangzhou) Hospital

Diagnostic Test: Diagnosis of postoperative recurrence of liver cancer

Interventions

Diagnosis of postoperative recurrence of liver cancer 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.

First Affiliated Hospital, Zhejiang University School of Medicine; Shulan (Hangzhou) Hospital

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

From January 2015 to December 2020, the electronic medical records of liver cancer patients who underwent liver transplantation at the First Affiliated Hospital, Zhejiang University School of Medicine and Shulan (Hangzhou) Hospital were retrospectively reviewed.Recipients were followed up after liver transplantation until Dec 31, 2022. During the follow-up period, the recipients were managed according to a standard protocol. All recipients received a nucleoside analog after liver transplantation. 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.

You may qualify if:

• (1) preoperative diagnosis of HBV-related HCC and (2) pathologically confirmed HCC.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhejiang University: lead

Related Publications (1)

• 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.

  PMID: 38348848 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: January 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: June 1, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share