Application of Endoscopic Scissors Cutting Endoscopic Nasobiliary Drainage Tube in the Treatment of Malignant Hilar Biliary Strictures: a Multicenter, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- occurrence of acute cholangitis
研究概览
简要总结
The purpose of this study is to evaluate application value of the endoscopic cutting technique in the treatment of malignant hilar biliary strictures.
详细描述
The management unresectable malignant hilar biliary strictures is still very difficult in spite of the rapid development of new endoscopic devices.The application of stent (plastic or metallic) has allowed us to achieve successful drainage. However,there are many complications related to the placement of stents,such as cholangitis,high rate of re-intervention,and so on. The application of endoscopic cutting technique is considered to reduce these complication.
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
- •Patients age over 18 and able to tolerate ERCP.
- •Pathologically confirmed inoperable malignant hilar biliary strictures of Bismuth type II to IV.
- •No history of biliary tract surgery and first attempt at endoscopic or percutaneous drainage.
- •No acute cholangitis before ERCP.
- •Informed consent.
排除标准
- •The patient is very ill(Septic shock, sepsis,coagulation disorders and so on) and cannot tolerate endoscopic treatment.
- •Previous biliary drainage procedure.
- •Inability to provide informed consent.
- •Participating in other clinical trials.
结局指标
主要结局
occurrence of acute cholangitis
时间窗: 30 days
Acute cholangitis is defined as cholangitis that occurred within 30 days after endoscopic retrograde cholangiopancreatography(ERCP).
次要结局
- Clinical success(30 days)
- Re-intervention(6 months)
研究者
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital