EPBD+Small EST VS. Large EST in Patients With Choledocholithiasis Complicated With Duodenal Papillary Diverticula
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- postoperative recurrent rate
研究概览
简要总结
The investigators hypothesized that nipple balloon dilatation could make ERCP more successful and reduce postoperative complications and mortality. So the investigators design this experiment on this assumption.
详细描述
The incidence of periampullary diverticula in patients with choledocholithiasis is very high at 47.1%. A large number of literatures refered that duodenal papillary diverticulum is a high risk factor for postoperative complications and recurrence of choledocholithiasis . Till now, there have been no randomized controlled trials to explore the effect of nipple balloon dilatation (EPLBD) on the treatment and prognosis of patients with choledocholithiasis complicated with periampullary diverticula (found during ERCP).
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with choledocholithiasis.
- •During ERCP, the patient was diagnosed as choledocholithiasis combined with duodenal papillary diverticulum.
- •choledocholithiasis no larger than 1.5 cm
排除标准
- •Patients with duodenal papillary tumor.
- •Patients with gastrointestinal duct obstruction endoscopy who cannot be operated and who have endoscopic contraindications.
- •Patients with duodenoscopy contraindications.
- •Patients with severe pancreatitis and other serious diseases.
结局指标
主要结局
postoperative recurrent rate
时间窗: 1 year
Recurrence rate of choledocholithiasis
time of operation
时间窗: 1-4 hours
duration of the ERCP
Incidence of complications
时间窗: 1 month
total complications occurded after operation
次要结局
未报告次要终点