The Efficacy and Safety of Endoscopic Scissors Cutting Nasobiliary Ducts in the Treatment of Malignant Hilar Biliary Tract Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- The occurrence of cholangitis
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of endoscopic scissors cutting nasobiliary ducts in the treatment of malignant hilar biliary tract stenosis
详细描述
The early diagnosis of hilar bile duct stenosis is difficult, and when the patient is diagnosed, the opportunity for surgical radical resection is lost, resulting in a poor prognosis. Effective palliative treatment can significantly improve their quality of life and survival time. The method of cutting nasobiliary ducts with endoscopic scissors has many advantages. Firstly, there are multiple lateral foramen of the nasobiliary duct, which increases the drainage area. Secondly, the nasobiliary duct can be retained in the secondary bile duct, which is difficult to achieve with a conventional stent. The use of nasobiliary ducts can also reduce the difficulty of converting from external drainage to internal drainage.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old and under 80 years old who were planned to carry out ERCP for malignant hilar biliary duct stenosis
- •Clinically and pathologically confirmed malignant hilar biliary duct stenosis
- •MRCP determines Bismuth classification: II-IV type
- •Comply with research procedures and sign the informed consent form
排除标准
- •The patient has multiple organ dysfunction and cannot tolerate endoscopic treatment
- •The patient has undergone biliary drainage (endoscopic, percutaneous, or surgical)
- •The patient is currently suffering from cholangitis
- •The patient is participating in other clinical trials
- •Inability to provide informed consent
结局指标
主要结局
The occurrence of cholangitis
时间窗: 1 month
Cholangitis that occurred within 1 month after endoscopic retrograde cholangiopancreatography(ERCP).
Clinical success
时间窗: 1 month
Clinical success was defined that the decrease in the total bilirubin level to less than 50% of the pretreatment value within 1 week or to less than 75% within 1 month.
次要结局
- Re-intervention(6 month)
- Adverse events(1 month)
研究者
Jianfeng Yang
Department director
First People's Hospital of Hangzhou