A Randomized Controlled Trial of Malignancy Low Biliary Tract Obstruction Drainage Strategies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- stent patency time
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of EUS-BD compared with ERCP-BD in low biliary obstruction caused by periampullary cancer, pancreatic cancer or low bile duct cancer. This is a single center, prospective, randomized-controlled study. The primary endpoint of this study is stent patency time, and secondary endpoints include technical success rate, clinical success rate, operation time, operation related complications rate, reintervention rate, stent patency rate at 6 months, and 1-year postoperative survival rate.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18 years old or above;
- •Periampullary cancer/pancreatic cancer according to pathology or clinical judgment of more than 2 senior doctors;
- •Distal malignant bile duct obstruction (2cm away from the hepatic hilum);
- •Ultrasound evaluation shows that the accessible part of the bile duct has a width of ≥ 12mm;
- •The patient or family member is able to understand the research protocol and is willing to participate in this study, providing written informed consent.
排除标准
- •Patients suffer from severe cardiovascular or pulmonary diseases who are unable to tolerate anesthesia or endoscopic examination;
- •Uncorrectable coagulation abnormalities or bleeding tendencies (INR>1.5 or platelets<50) × 109 /L);
- •There is a plan for subsequent surgical resection of the tumor, accompanied by severe infection or an expected survival period of less than 3 months;
- •Successful biliary drainage measures have been implemented, including but not limited to ERCP, ENBD, PTCD, and surgical procedures;
- •Previous surgical changes to the anatomical structure of the pancreas, gallbladder, stomach, and duodenum;
- •Pregnancy, lactation, or planned pregnancy;
- •Refusal to join or inability to provide informed consent;
- •Other researchers evaluated the unsuitability of enrollment.
研究组 & 干预措施
EUS-BD
Endoscopic Ultrasound-guided Biliary Drainage
干预措施: EUS-BD (Procedure)
ERCP-BD
Endoscopic Retrograde Cholangiopancreatography
干预措施: ERCP-BD (Procedure)
结局指标
主要结局
stent patency time
时间窗: 0-24months
The interval between the operation day and the occurrence of cholangitis and biliary obstruction
次要结局
未报告次要终点
研究者
Wu Xi
associate professor，M.D.
Peking Union Medical College Hospital