Prediction and Prognostic Analysis of Liver Abscess Formation After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma : a Retrospective Multicenter Nested Case-control Study (CHANCE 2407)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Whether combined immunotherapy was a risk factor for liver abscess formation after TACE.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case group inclusion criteria:
- •Time period of inclusion: 2009-2023 (15 years)
- •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.
- •Control group inclusion criteria
- •Patients with HCC without liver abscess who underwent TACE in the same center within the week of treatment in the case group.
排除标准
- •Clinical and follow-up data were incomplete
- •Loss to follow-up
结局指标
主要结局
Whether combined immunotherapy was a risk factor for liver abscess formation after TACE.
时间窗: one year
The immunotherapy of patients with and without liver abscess after TACE was collected, and conclusion was drawn by univariate and multivariate analysis.
Whether combined targeted therapy was a risk factor for liver abscess formation after TACE.
时间窗: one year
The targeted treatment of patients with and without liver abscess after TACE was collected, and conclusion was drawn by univariate and multivariate analysis.
次要结局
- Survival time of patients with liver abscess formation after TACE.(one year)
研究者
Zhihui Chang
Professor
Shengjing Hospital
