Prediction and Prognostic Analysis of Liver Abscess Formation After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (CHANCE 2407)

NCT ID: NCT06483594

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-06-30

Brief Summary

Liver abscess is a rare but serious complication of hepatocellular carcinoma after TACE, with an incidence of less than 1% reported in previous literature. Studies have shown that history of biliary tract disease, tumor size, embolization materials and embolization endpoint selection may be related to the occurrence of abscess. In recent years, with the wide application of targeted and immune drugs, there have been reports of multiple cases of liver abscess after single target immunotherapy for liver cancer, and there have also been studies showing that TACE combined with targeted immunotherapy can significantly increase the degree of liquefaction necrosis and increase the risk of liver abscess. However, these studies are single-center reports with small sample size and low level of evidence. Therefore, it is of great clinical significance to explore the risk factors of liver abscess after TACE and build a prediction model by using multi-center and large sample data. The formation of liver abscess after TACE means a large range of tissue liquefaction necrosis. There are reports of high incidence of early recurrence and metastasis of liquefaction necrosis. Some studies also show that tumor necrosis is more complete when liver abscess is combined with complete remission. In previous studies, ORR in patients with liver cancer complicated with liver abscess ranged from 18.75%-100%, with significant differences in reports from different centers. The effect of specific abscess formation on TACE efficacy of liver cancer remains to be determined. Therefore, the second research focus of this project is to explore the effect of liver abscess formation after TACE on prognosis of liver cancer.

Conditions

TACE; HCC - Hepatocellular Carcinoma; Liver Abscess

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with liver abscess formation after TACE for HCC

No interventions assigned to this group

Patients without liver abscess after TACE with HCC

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Time period of inclusion: 2009-2023 (15 years)

2. Patients with HCC diagnosed by clinical or pathological criteria according to the National Health Commission guidelines for the diagnosis and treatment of primary liver cancer who underwent TACE after surgery and developed postoperative liver abscess.

3. Appendix: Diagnostic criteria for liver abscess after TACE:

Condition 1: CT images show typically low-density lesions with or without air and fluid levels

Condition 2:

• positive blood culture
• Percutaneous drainage or aspiration is purulent or culture-positive
• Symptoms of infection such as fever/chills, accompanied by elevated inflammatory markers such as white blood cell count, C-reactive protein, or procalcitonin.

1. Patients with HCC without liver abscess who underwent TACE in the same center within the week of treatment in the case group.

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Exclusion Criteria

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1. Clinical and follow-up data were incomplete

2. Loss to follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Zhongda Hospital

OTHER

Sponsor Role: collaborator

Changzhou No.2 People's Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhihui Chang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhihui Chang

Role: CONTACT

Changzh@sj-hospital.org

＋86-18940258437

Other Identifiers

2024PS1094K

Identifier Type: -

Identifier Source: org_study_id