Construction and Evaluation of the Early Identification and Individualized Treatment for Oxaliplatin-induced Portal Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1-year rebleeding rate
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, we aim to evaluate the efficacy of individualized treatment in patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Sign written informed consent
- •Male or female patients aged 18-75
- •diagnosed as portal hypertension by contrast-enhanced computed tomography
- •and confirmed gastroesophageal varices by upper digestive endoscopy;
- •had a history of oxaliplatin-based chemotherapy after 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
- •Other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.
结局指标
主要结局
1-year rebleeding rate
时间窗: 1 year
1-year rebleeding rate
次要结局
- Complications of portal hypertension(1 year)
- 1-year death rate(1 year)
研究者
Shiyao Chen
Professor
Fudan University