Efficacy and Safety Comparison of Balloon Catheter and Basket Catheter for Endoscopic Pancreatic Duct Stone Clearance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,493
- 试验地点
- 1
- 主要终点
- the rate of stone clearance in basket and balloon catheter groups
研究概览
简要总结
The aim of the study is to compare the safety and efficacy of the basket catheter with that of the balloon catheter for endoscopic extraction of pancreatic stones.
详细描述
This is a retrospective cohort study. Patients with chronic pancreatitis who underwent ERCP for pancreatic duct stone extraction using either a basket or a balloon catheter were enrolled in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CP patients with main pancreatic duct (MPD) stones who underwent ERCP
排除标准
- •Patients had undergone pancreatic surgery or gastrectomy with Billroth II reconstruction prior to the ERCP procedure
- •Patients were suspected of having a malignant tumor
- •Patients combined with bile duct stones
- •Patients had severe pancreatic duct structure
- •Patients with insufficient clinical data
- •Patients with previous ERCP treatment
- •Patients had received both catheters
结局指标
主要结局
the rate of stone clearance in basket and balloon catheter groups
时间窗: 1 year after ERCP
complete clearance, defined as fragmentation of the pancreatic stones to \< 3 mm and clearance of more than 90% of the fragments; partial clearance, defined as clearance of 50-90% of the fragments; and unsuccessful clearance, defined as the presence of pancreatic stones ≥ 3 mm or clearance of less than 50% of the fragments.
次要结局
- the rates of ERCP peri-procedural outcomes and the rates of complications of ERCP in basket and balloon catheter groups(1 year after ERCP)
研究者
Zhuan Liao
Principal Investigator
Changhai Hospital