Best Biliary Drainage Option in Type II、III、IV Klatskin Tumor：ERCP or PTBD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Acute cholangitis
研究概览
简要总结
To investigate the biliary drainage-related cholangitis and other complications of percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT) compared with endoscopic biliary drainage (EBD).
详细描述
Operative treatment combined with preoperative biliary drainage (PBD) has been established as a safe management strategy for KT. Preoperative cholangitis was an independent risk factor for patients undergoing resection for KT. However, controversy exists regarding the preferred technique for PBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II、III、IV Klatskin tumor patients;
- •18-90 years old
排除标准
- •Unwillingness or inability to consent for the study;
- •Coagulation dysfunction (INR> 1.3) and low peripheral blood platelet count(<50×109 / L) or using anti-coagulation drugs;
- •Previous endoscopic sphincterectomy (EST) or endoscopic papillary balloon dilatation (EPBD);
- •Any type of GI reconstruction;
- •Combined with Mirizzi syndrome and intrahepatic bile duct stones;
- •Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock;
- •Biliary-duodenal fistula;
- •Pregnant women
研究组 & 干预措施
Biliary drainage 1
Patients with advanced hilar cholangiocarcinoma need biliary drainage performed Endoscopic Retrograde Cholangiopancreatography (ERCP) drainage
干预措施: ERCP Drainage (Procedure)
Biliary drainage 2
Patients with advanced hilar cholangiocarcinoma need biliary drainage performed percutaneous transhepatic biliary drainage(PTBD) drainage
干预措施: PTBD Drainage (Procedure)
结局指标
主要结局
Acute cholangitis
时间窗: 2 weeks
Acute cholangitis is defined if patients experienced abdominal pain, high fever, or chill after procedure in 2 weeks
次要结局
- Length of hospital stay(6 months)
- Abdominal pain(2 weeks)
- Overall procedure related complication rate(6 months)
研究者
Wenbo Meng
M.D., Ph. D,
Hepatopancreatobiliary Surgery Institute of Gansu Province