Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Overall morbidities
研究概览
简要总结
Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in treatment of this condition has been demonstrated but how the two procedures compare to one another is uncertain.
The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.
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
- •Consecutive patients aged ≥ 18 years old admitted for acute cholecystitis but are unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions including: American society of anesthesiology grading ≥ 3, APACHE score ≥ 12, limited life expectancy (less than 2 years) or deemed unsuitable for general anesthesia would be included.
- •Written informed consent from patient or guardian who is able to understand the nature and possible consequences of the study
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)
- •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: INR > 1.5 and/or platelets < 50.000/mm3
- •Previous drainage of the gallbladder
研究组 & 干预措施
EUS-guided gallbladder drainage
干预措施: EUS-guided gallbladder drainage (EGBD) (Procedure)
Percutaneous cholecystomy
干预措施: Percutaneous cholecystostomy (PC) (Procedure)
结局指标
主要结局
Overall morbidities
时间窗: 1 years
次要结局
- Technical success(30 days)
- Pain scores(7 days)
- Analgesic requirements(7 days)
- Stone clearance rates(1 years)
- Clinical success(30 days)
- Reintervention rate(1 year)
- Re-admission rate(1 year)
研究者
Anthony Teoh
Honorary Associate Professor
Chinese University of Hong Kong