Prospective Randomized Controlled Trial for Endoscopic Ultrasound Guided and Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Clinical response rate
研究概览
简要总结
The investigators would like to conduct a prospective, randomized non-inferiority study to compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients.
详细描述
The primary outcome is to compare clinical resolution rate of EUS-guided gallbladder drainage versus percutaneous transhepatic gallbladder drainage in acute cholecystitis patients with high risk.
The secondary outcome is to compare complications, conversion rate to open cholecystectomy during laparoscopic cholecystectomy.
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
- •high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)
排除标准
- •Age below 18 years
- •Pregnancy
- •When the risks of endoscopy to patient are judged to outweigh the most favorable benefits of the procedure.
- •Unstable or unwilling to comply with follow-up
- •When a perforated viscus is known or suspected
- •Simultaneously participating in another investigational drug or device study
结局指标
主要结局
Clinical response rate
时间窗: Within 72 hours from procedure
Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation.
次要结局
- Complication rate(Complications during the procedure or within 1 weeks)
- Conversion rate(During laparoscopic cholectstectomy)