Endoscopic Ultrasound (EUS)-Guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical success rate
研究概览
简要总结
To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy.
详细描述
The gold standard for treatment of acute calculous cholecystitis is laparoscopic cholecystectomy. Recently, gallbladder drainage with EUS-guided gallbladder drainage (EGBD) has been described as a treatment option. However, whether this is an effective treatment option in surgically fit patients are uncertain.
The aim of the current study is to evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy. The investigators hypothesis that the technique is safe and feasible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included.
排除标准
- •Pregnancy
- •Patients unwilling to undergo follow-up assessments
- •Patients with suspected gangrene or perforation of the gallbladder
- •Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
- •Patients with duodenal obstruction
- •Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
- •Patients with liver cirrhosis, portal hypertension and/or gastric varices
- •Abnormal coagulation: international normalised ratio (INR) > 1.5 and/or platelets < 50.000/mm3
- •Previous drainage of the gallbladder
结局指标
主要结局
Clinical success rate
时间窗: 30 days
Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10%
次要结局
- Mortality rate(3 years)
- Technical success rate(30 days)
- 30-day adverse events rate(30 days)
- Stone or polyp recurrences(3 years)
- Quality of life scores: Gastrointestinal quality of life index(3 years)
- Reintervention rate(3 years)
研究者
Anthony Teoh
Honorary Associate Professor
Chinese University of Hong Kong