Upfront Endoscopic Ultrasound-guided Gallbladder Drainage (EUS-GBD) Versus Standard Protocol (Antibiotics First) for Mild to Moderate Acute Cholecystitis in Patients Who Are Very-high-risk for Cholecystectomy: A Randomized-controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- 1-year recurrent acute cholecystitis rate
研究概览
简要总结
Objectives Acute cholecystitis commonly occurs in elderly patients who are at high-risk for surgery. Whether upfront Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is advantageous over antibiotics first for mild acute cholecystitis is uncertain.
Hypothesis to be tested The aim is to compare EUS-GBD versus standard protocol (antibiotics first) as a definitive treatment, in very high-risk patients suffering from mild to moderate acute cholecystitis. We hypothesize that EUS-GBD can reduce the 1-year risk of recurrent acute cholecystitis.
Design and subjects This is an international randomised controlled study including consecutive patients suffering from acute cholecystitis that are very high-risk for cholecystectomy. The patients would be randomized to receive EUS-GBD or antibiotics first.
Interventions: EUS-GBD versus antibiotics
Main outcome measures:
The primary outcome is the rate of recurrent acute cholecystitis in 1 year. Other outcomes include technical and clinical success, post-procedural pain scores, analgesic requirements, adverse events, re-admissions, re-interventions, quality of life and cost analysis.
Data analysis All outcomes would be analysed according to the intention-to-treat principle. Kaplan-Meier method with the log-rank test will be used to compare differences in recurrent acute cholecystitis in 1 year. A health economic analysis will also be performed. Assuming a 17.1% difference in recurrent acute cholecystitis rates, a 2-sided P value of 0.05, a power of 80%, and a 10% dropout rate, 110 patients is required.
Expected results The findings of this study can help establish the role of EUS-GBD in management of high-risk patients suffering from acute cholecystitis over antibiotics alone and Percutaneous transhepatic gallbladder 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients aged ≥ 18 years old
- •Suffering from grade 1 or 2 acute calculous cholecystitis*
- •At very high-risk for early laparoscopic cholecystectomy due to poor premorbid conditions** or elderly patients suffering from acute cholecystitis but refused operations
排除标准
- •Patients with the following conditions are excluded from the study:
- •Pregnancy
- •Patients unwilling to undergo follow-up assessments
- •Patients with suspected gangrene or perforation of the gallbladder
- •Grade III acute cholecystitis33
- •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: International normalized ratio (INR) > 1.5 and/or platelets < 50.000/mm3
- •Previous drainage of the gallbladder
- •Patients suffering acute cholecystitis due to malignant cystic duct obstruction
- •Patients with life expectancy of less than 3 years
研究组 & 干预措施
Antibiotics first group
Antibiotics first equals to intravenous antibiotics 2nd generation cephalosporin or equivalent). Antibiotics would first be given parenterally and then switched to oral form when patient can tolerate diet or when sepsis subside. It will be continued for at least a total of 7 days.
干预措施: Antibiotics first (Drug)
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD)
Prior to the procedure, the patients would be kept fasted for 6 hours and antibiotics would be commenced (2nd generation cephalosporin or equivalent). Antibiotics would be continued for up to one week after the procedure.EUS-GBD would be performed by either the conventional or direct method.
干预措施: Endoscopic ultrasound-guided gallbladder drainage (Procedure)
结局指标
主要结局
1-year recurrent acute cholecystitis rate
时间窗: 1-year
recurrent acute cholecystitis rate in 1 year
次要结局
- Technical success(1-year)
- Clinical success (laboratory tests)(1-year)
- Daily post-procedural pain scores for the first 7 days(7 days)
- Quality of life assessment(1-year)
- Total number of unplanned readmissions related to acute cholecystitis and reinterventions(1-year)
- Cost-effectiveness measurement(1-year)
- Type and dosage of analgesic required(an average of 7 days)
- Clinical success (clinical symptoms)(1-year)
- Adverse events(1-year)
研究者
CHAN SHANNON MELISSA
Assistant Professor
Chinese University of Hong Kong