Construction and Evaluation of the Early Identification for Oxaliplatin Induced Portal Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- the severity of portal hypertension
研究概览
简要总结
Oxaliplatin has been used as the first choice for the adjuvant chemotherapy of colorectal cancer and it has significantly improved the outcomes in patients with colorectal cancer. However, hepatotoxicity is the potentially problematic adverse effect of oxaliplatin. The pathological evaluation of non-tumoral liver from patients with advanced colorectal cancer undergoing neoadjuvant oxaliplatin-based treatment has provided histological evidence of hepatic sinusoidal injury. Oxaliplatin-induced sinusoidal injury can persist for more than 1 year after the completion of chemotherapy, and the increase in splenic volume may be a predictor of irreversible sinusoidal damage. In this current study, the investigators aim to evaluate the values of potential biomarkers in diagnosing patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18-75
- •Had a history of oxaliplatin-based chemotherapy for the treatment of colorectal cancer surgery;
排除标准
- •Combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.
- •With colorectal cancer required further anti-tumor treatment
结局指标
主要结局
the severity of portal hypertension
时间窗: 1 day (the same time as diagnosis)
High portal pressure
次要结局
未报告次要终点
研究者
Shiyao Chen
Professor
Shanghai Zhongshan Hospital