Effects of Antiviral Therapy on Patients With HBV-related HCC
Effects of Short-term and Perioperative Antiviral Therapy on Prognosis After Hepatectomy for Hepatitis B Virus-related Hepatocellular Carcinoma
1 other identifier
observational
494
0 countries
N/A
Brief Summary
Based on the follow-up data of patients who underwent hepatectomy for HBV-related HCC at the First Affiliated Hospital of Xi'an Jiaotong University. patients who met the enrollment criteria were screened for tumor recurrence and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedFirst Submitted
Initial submission to the registry
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 6, 2022
CompletedJune 21, 2022
June 1, 2022
3.5 years
June 1, 2022
June 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Post-operative survival time
Postoperative survival time for patients receiving hepatectomy
Time from the end of hepatectomy to the patient's death, or the end of follow-up by December 31, 2020. whichever came first, assessed up to 60 months
Recurrence of the hepatocellular carcinoma after hepatectomy
Recurrence of the hepatocellular carcinoma in patients who underwent hepatectomy
The time period between hepatectomy and the initial examination revealing a recurrence of hepatocellular carcinoma, or until the end of follow-up on December 31, 2020.whichever came first, assessed up to 60 months.
Secondary Outcomes (1)
Surgery information
Intraoperative
Study Arms (2)
The short-term antiviral therapy (STAT) group
The short-term antiviral therapy (STAT) group was defined as individuals who received HBV antiviral ( antiviral treatments consisted of adefovir (10 mg/day), entecavir (0.5 mg/day), and lamivudine (100 mg/day) )at least 24 weeks before hepatectomy (antiviral therapy still continued during perioperative period). Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and characteristics of this group were collected and recorded for subsequent analysis.
The perioperative antiviral therapy (PAT) group
The perioperative antiviral therapy (PAT) group was defined as individuals who received antiviral treatment perioperatively ( antiviral treatments consisted of adefovir (10 mg/day), entecavir (0.5 mg/day), and lamivudine (100 mg/day) ). Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and characteristics of this group were collected and recorded for subsequent analysis.
Interventions
The study was retrospective and did not involve the application of interventions
Eligibility Criteria
Adult patients (age 18 or older) who underwent hepatectomy between January 1st, 2016, and June 30st, 2019, were retrospectively identified using the database for clinical data in the First Affiliated Hospital of Xi'an Jiaotong University
You may qualify if:
- Age of 18-70 years; Initial hepatectomy was performed; Positive HBsAg results and negative results for antibodies to hepatitis C virus (HCVAb) and human immunodeficiency virus; The patient did not undergo antitumor treatment, such as transcatheter arterial chemoembolization, radiofrequency ablation-chemotherapy or radiotherapy, or postoperative liver transplantation; Barcelona Clinic Hepatocellular carcinoma stage 0, A, or B (a few patients with stage C were also enrolled); Negative hepatectomy margin; No other tumors.
You may not qualify if:
- Undergo antitumor treatment, such as transcatheter arterial chemoembolization, radiofrequency ablation-chemotherapy or radiotherapy, or postoperative liver transplantation; Positive results for antibodies to hepatitis C virus (HCVAb) and human immunodeficiency virus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bo Wang, MD PhD
First Affiliated Hospital Xi'an Jiaotong University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 1, 2022
First Posted
June 6, 2022
Study Start
January 1, 2016
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
June 21, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share
The study was based on database from the The First Affiliated Hospital of Xi'an Jiao Tong University , researchers did not have access to patients' information nor raw data unless approved by the Ethics Committee of The First Affiliated Hospital of Xi'an Jiao Tong University.