Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence of postoperative complication
研究概览
简要总结
This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma.
详细描述
Preoperative biliary drainage(PBD) or not, is a Hot Spot issue in the management of Hilar cholangiocarcinoma. Surgeons from Japan tend to perform PTBD(Percutaneous Transhepatic Biliary Drainage) before a definite operation until the total bilirubin(TB) lower than 85μmol/L. For some patients needed to perform extended curative resection, PVE(Portal Vein Embolization) is performed and thus the duration of PBD may be around six weeks and the final TB is lower than 34μmol/L. Some tend to perform a definite curative operation in a short time after diagnosis. There is no RCT research on the effect of PBD for the resectable Hilar Cholangiocarcinoma patients to date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients newly diagnosed
- •Resectable patients after imaging assessment and evaluation of general condition of the patient
- •TB>85μmol/L
- •WBC account more than 1.5×109/L, PLT account more than 100×109/L and HB account more than 100g/L
- •No serious disease in heart, lung and kidney
- •Written informed consent
排除标准
- •Unresectable patients.
- •Patients have received biliary drainage procedure such as PTBD before admission
- •Complicated with chronic hepatitis
- •Myocardia infarction record within six months
- •Women in pregnancy
- •Serious disease in heart, lung or kidney
结局指标
主要结局
Incidence of postoperative complication
时间窗: 30 days after operation
次要结局
- Disease free survival, DFS(May, 2013)
- Postoperative mortality(30 days after operation)
- Overall survival, OS(May, 2013)