Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer: a Multicenter, Randomized, Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Treatment related complications
研究概览
简要总结
The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol versus conventional treatment on patients who underwent liver resection for hepatocellular carcinoma(HCC).
详细描述
212 patients are randomly recruited from inpatients of Shanghai Zhongshan Hospital, Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province and Affiliated Tumor Hospital of Nantong University from February 2016 to July 2016. Randomly assigned about half of the patients to receive Enhanced Recovery After Surgery(ERAS) protocol and the other half to receive conventional treatment. Evaluate the safety and efficacy of the ERAS protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with HCC with indications for surgery
- •Without any surgical contraindications
- •Under went open liver resection
- •Operation ranges less than 4 hepatic segments
- •Informed consent
排除标准
- •Not suitable for surgery
- •Benign lesions or other lesions proved by pathology
- •Surgical procedure changed during operation or combined evisceration
- •Refused to participate or drop out
结局指标
主要结局
Treatment related complications
时间窗: Up to 1 month since operation
Number of adverse events that are related to treatment of each patients, and hospital readmission
次要结局
- Total hospitalization costs(From the day a patient be hospitalized to the day discharged, up to 1 month.)
- Preoperative and postoperative body weight(One day before operation, and the day patient discharged, up to 1 month.)
- PRE-Albumin (PRE-A)(Day before operation and day 1/3/5 after operation.)
- International Normalized Ratio (INR)(Day before operation and day 1/3/5 after operation.)
- Albumin (ALB)(Day before operation and day 1/3/5 after operation.)
- Blood Urea Nitrogen (BUN)(Day before operation and day 1/3/5 after operation.)
- Length of stay in hospital(From the day a patient be hospitalized to the day discharged, up to 1 month.)
- Aspartate Transaminase (AST)(Day before operation and day 1/3/5 after operation.)
- Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L),(Day before operation and day 1/3/5 after operation.)
- Platelet (PLT)(Day before operation and day 1/3/5 after operation.)
- Serum complement(Day before operation and day 1/3/5 after operation.)
- Blood Creatinine (sCr)(Day before operation and day 1/3/5 after operation.)
- Alanine Transferase (ALT)(Day before operation and day 1/3/5 after operation.)
- Interleukin-6 (IL-6)(Day before operation and day 1/3/5 after operation.)
- Interferon (IFN-γ)(Day before operation and day 1/3/5 after operation.)
- Tumor necrosis factor-α (TNF-α)(Day before operation and day 1/3/5 after operation.)