Division of Hepato-gastroenterology; Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung,Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Post ERCP pancreatitis
研究概览
简要总结
In expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for stone removal later. However, in the recent study, single-stage endoscopic treatment may be still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis associated with choledocholithiasis. Investigators will carry out a prospective trial to analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate cholangitis with choledocholithiasis to determine the safety, successful rate, and complications in these two groups.
详细描述
Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis. The method of one-stage: performing the stone removal at the first session of ERCP. The pancreas duct stent will be placed for preventing post ERCP pancreatitis (PEP) if necessary. The indomethacin 100mg anal route will be administered for all patients without allergy history. All participants will receive the empiric antibiotics treatment for cholangitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis.
排除标准
- •procedural failure requiring an anatomy-modifying procedure, such as a Billroth II subtotal gastrectomy or R-en-Y gastrojejunostomy ;
- •stenosis of the pyloric ring ;
- •tumor-related obstruction;
- •failure to locate the papilla ;
- •active peptic ulcer bleeding ;
- •intolerance due to inadequate sedation
- •CBD sludge;
- •non-naïve papilla in ERCP
结局指标
主要结局
Post ERCP pancreatitis
时间窗: After ERCP, an average of 7 days
Serum amylase \> 3 times of (115 IU/L) with clinical abdominal pain
Bowel perforation
时间窗: After ERCP, an average of 7 days
Participants with sign of bowel perforation after ERCP
Papillary bleeding
时间窗: After ERCP, an average of 7 days
Participants with papillary bleeding after ERCP
Success rate of stone removal
时间窗: an average of 14 days.
Complete bile duct stone clearance
Cost of hospitalization
时间窗: From emergent department to the timing of being discharged, and an average of 30 days
Total cost in two individual groups in hospitalization.
次要结局
- Mortality(an average of 30 days)