Role of EUS in High Risk of Choledocholithiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure
研究概览
简要总结
The aim of this study is to demonstrate that patients with high risk of choledocholithiasis who undergo ERCP only for patients with choledocholith in the EUS examination[EUS-ERCP group] have less negative outcomes (including false-negative results and procedure-related complications) than patients who undergo ERCP in all patients with high risk of choledocholithiasis[ERCP group]. The primary outcome is the incidence of negative outcomes (including false-negative results and procedure-related complications) in both groups. The secondary outcomes included days of hospitalization and the rate of diagnostic ERC.
详细描述
Several studies have shown that EUS testing prior to ERCP may reduce ERCP complications in patients with intermediate-risk choledocholithiasis. In other words, this results obtained by not performing ERCP in patients without choledocholith in the EUS examination. However, to the best of our knowledge, no prospective study has been conducted on the role of EUS in patients with high risk of choledocholithiasis. Therefore, we investigate the role of EUS screening in patients with high risk of choledocholithiasis. We compare the negative outcomes (including false negative and procedure-related complications of EUS and ERCP) of the 'EUS-ERCP group' in which ERCP is performed when necessary after the EUS examination and the 'ERCP group' in which ERCP is performed in all patients.
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
- •Abdominal CT or US showed a common bile duct diameter > 6mm (>8mm in patients with previous cholecystectomy) and elevated total bilirubin from 1.8mg/dL to less than 4.0mg/dL
排除标准
- •Severe mental illness
- •Severe co-morbidity (ESRD, Advanced COPD, severe Heart failure, poorly controlled blood sugar)
- •Pregnancy
- •Pancreatic cancer or suspected malignant tumor of the biliary tract
- •Acute pancreatitis
- •Patient who has confirmed biliary stones in abdominal ultrasonography or CT
- •Severe cholangitis according to TG 18 guideline
- •Total bilirubin > 4mg/dL
- •Patients who have difficulty with EUS or ERCP due to previous gastric surgery (Billroth II or TG with R-en-Y)
结局指标
主要结局
Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure
时间窗: 6 months after randomization
Negative outcomes associated with a false-negative diagnosis of choledocholithiasis were defined as follows: 1) diagnosis of choledocholithiasis during follow-up or 2) hospitalization for a condition likely associated with choledocholithiasis, such as biliary pancreatitis, cholangitis, or obstructive jaundice. Negative outcomes of endoscopic procedures were assessed according to the ASGE lexicon
次要结局
- Length of hospital stay(6 months after randomization)
研究者
Woo Hyun Paik
Professor
Seoul National University Hospital