A Retrospective Study of Surgical Resection Combined With Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Ruptured Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Intra-abdominal recurrence-free survival (RFS)
研究概览
简要总结
Patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into experimental and control groups. the primary efficacy end point was RFS, and the secondary end point was the rate of abdominal implant metastases and OS.To analyze the efficacy of HIPEC.
详细描述
Patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into groups: experimental group: surgical resection combined with intraperitoneal hyperthermic perfusion chemotherapy, and control group: simple surgical resection.
At further follow-up, the primary efficacy end point was time to Recurrence free survival (RFS) ,the time from the patient's treatment until the discovery of abdominal metastases or until the follow-up period, and the secondary end point was the rate of abdominal implant metastases, that is, according to the postoperative follow-up test and imaging findings, the incidence of abdominal implantation and metastasis, until the end of abdominal recurrence or metastasis or observation period. Overall Survival OS and survival rate: the time from the time the patient underwent partial hepatectomy until death from tumor causes or the end of the observation period. To analyze the efficacy of HIPEC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •according to the clinical diagnostic criteria of primary liver cancer (2022 edition) or confirmed by pathology/cytology;
- •preoperative diagnosis of rupture and hemorrhage of liver cancer by clinical manifestation, examination and imaging;
- •Age 18-80 years;
- •Child-pugh class A or class B after liver protection and albumin correction, without severe heart, lung or renal dysfunction, without absolute contraindication to surgery;
- •ECOG-PS score of 0-1;
- •without other neoplastic diseases;
- •Sign and perfect the informed consent form before operation;
- •without postoperative liver failure, without major complications such as massive hemorrhage, purulent infection and multiple organ failure, and without discharge from hospital.
排除标准
- •having other active malignant tumor;
- •the expected survival time is less than 3 months;
- •Child-pugh class C, complicated with severe organic disease of important organs, complicated with severe cirrhosis.
结局指标
主要结局
Intra-abdominal recurrence-free survival (RFS)
时间窗: the time from surgical resection in patients with HCC until the detection of intra-abdominal recurrence or metastasis or the end of the observation period(2 years)
Intra-abdominal recurrence-free survival (RFS):the time from surgical resection patients with HCC until the detection of intra-abdominal recurrence or metastasis or the end of the observation period, based on postoperative follow-up test criteria and imaging findings(2 years)
次要结局
- survival rate(time from partial hepatectomy for HCC until death from any cause or end of observation period)
- Overall Survival (OS)(time from partial hepatectomy for HCC until death from any cause or end of observation period(2 years))