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

NCT06483594 | Not Yet Recruiting

• 1 other identifier: 2024PS1094K
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Whether combined targeted therapy was a risk factor for liver abscess formation after TACE.

  The targeted treatment of patients with and without liver abscess after TACE was collected, and conclusion was drawn by univariate and multivariate analysis.

  one year

• Whether combined immunotherapy was a risk factor for liver abscess formation after TACE.

  The immunotherapy of patients with and without liver abscess after TACE was collected, and conclusion was drawn by univariate and multivariate analysis.

  one year

Secondary Outcomes (1)

• Survival time of patients with liver abscess formation after TACE.

  one year

Study Arms (2)

Patients with liver abscess formation after TACE for HCC

Patients without liver abscess after TACE with HCC

Eligibility Criteria

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

Study Population

HCC patients from hospital interventional wards receiving TACE

You may qualify if:

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

You may not qualify if:

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• Clinical and follow-up data were incomplete
• Loss to follow-up

Sponsors & Collaborators

• Shengjing Hospital: lead
• First Hospital of China Medical University: collaborator
• Zhongda Hospital: collaborator
• Changzhou No.2 People's Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• Huazhong University of Science and Technology: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Abscess

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Abdominal Abscess; Abscess; Suppuration; Infections

Central Study Contacts

Zhihui Chang

CONTACT

＋86-18940258437; Changzh@sj-hospital.org

Study Design

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

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 3, 2024
• Study Start: June 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share