Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
研究概览
简要总结
Acute Cholangitis is an emergency associated with significant morbidity and mortality which require prompt recognition and treatment. The decompression of biliary tree along with antibiotics are mainstay of therapy. Randomized comparative studies showed that ERCP achieves biliary decompression with markedly less morbidity and mortality compared with surgery, regardless of clinical drainage. Percutaneous trans hepatic drainage (PTBD) can be alternative to endoscopic drainage in selected group especially advanced hilar strictures and patients who are unfit for endoscopic procedure.
Recent ASGE guidelines suggested the performance of ERCP within 48 hours for patients with acute cholangitis; however it is conditional recommendation with very low quality of evidence. Till date, no randomized trial has compared urgent ERCP versus early ERCP for acute cholangitis.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who met criteria for a definite diagnosis acute cholangitis.
排除标准
- •Patients with severe acute cholangitis at admission.
- •Age < 18 years.
- •Pregnancy.
- •Associated Acute Severe Pancreatitis.
- •Patients with suspected high grade (Bismuth III/IV) biliary stricture in whom PTBD is considered as primary method of biliary drainage.
- •Not giving consent.
结局指标
主要结局
ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization
时间窗: Two Years
To perform a single-centre, randomized trial comparing the efficacy (the ability to produce a desired or intended result) of urgent versus early ERCP (Endoscopic retrograde cholangiopancreatography) for reducing the risk of 30 days of mortality.
次要结局
- ERCP performed within 24 hours of hospitalization versus ERCP performed between 24 to 48 hours of hospitalization(Two Years)