Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice of Extrahepatic Bile Duct: A Multi-center, Prospective, Open-labeled, Real World Study Based on Electronic Data Capture System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 564
- 主要终点
- Complication rate after drainage
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including PTBD (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS (Endoscopic Biliary Stenting).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the following four criteria are included into the study:
- •Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery;
- •Serum total bilirubin is higher than 51 umol/l;
- •Age is older than 18 and younger than 80 years old;
- •Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD.
排除标准
- •If any of the following items are met, the subject cannot enter the study.
- •Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery;
- •Malignant obstructive jaundice caused by metastatic tumors;
- •Pregnancy or lactation women.
研究组 & 干预措施
Without PBD group
receive surgery without PBD
PTBD group
Percutaneous Transhepatic Biliary Drainage
干预措施: PTBD group (Procedure)
ENBD group
Endoscopic Nasobiliary Biliary Drainage
干预措施: ENBD group (Procedure)
EBS group
Endoscopic Biliary Stenting
干预措施: EBS group (Procedure)
结局指标
主要结局
Complication rate after drainage
时间窗: From PBD to completion of radical surgery, an average of 1 month
Complication rate between PBD (preoperative biliary drainage) and radical surgery
Success rate of PBD
时间窗: Day 1
Success rate of different methods of PBD
Complication rate after radical surgery
时间窗: 1 month post operatively
Complication rate after radical surgery
次要结局
- operative time(Day 1)
- Hepatoduodenal edema(at time of radical surgery)
- Rate of change in Total bilirubin(2 weeks after PBD)
- Perioperative mortality(from PBD to 4 weeks after surgery, an average of 2 month)
- implantation metastasis(Day 1)
- Rate of change in alanine aminotransferase(2 weeks after PBD)
- Rate of change in aspartate aminotransferase(2 weeks after PBD)