Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy and Endoscopic Retrograde Cholangiopancreatography for Pancreatic Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,071
- 试验地点
- 1
- 主要终点
- the incidence of post-ESWL adverse events
研究概览
简要总结
To determine the types, incidence and risk factors of adverse events after pancreatic extracorporeal shock wave lithotripsy (P-ESWL) and endoscopic retrograde cholangiopancreatography (ERCP), define the grading criteria of adverse events after P-ESWL and ERCP, and analyze the efficacy of P-ESWL and ERCP, which will provide evidence-based medical evidence to guide physicians' clinical practice.
详细描述
Currently, pancreatic extracorporeal shock wave lithotripsy (P-ESWL) and endoscopic retrograde cholangiopancreatography (ERCP) has become the preferred treatment for pancreatic duct stones. Although some studies had confirmed the safety and efficacy of P-ESWL and ERCP, the sample size were small and the follow-up period were short. Therefore, investigators designed this study with a large sample and a long follow-up period to clarify the efficacy and safety of P-ESWL and ERCP, so as to guide clinical work, standardize the diagnosis and treatment process of adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized in Changhai Hospital from 2011.03.01 to 2018.06.
- •Painful patients with chronic pancreatitis.
- •Patients who completed pancreatic extracorporeal shock wave lithotripsy.
排除标准
- •Patients who diagnosed pancreatic cancer within 2 years after diagnosing chronic pancreatitis.
- •Patients who refused to participate in the study.
结局指标
主要结局
the incidence of post-ESWL adverse events
时间窗: 1 months
An adverse event of P-ESWL is classified as either a complication or a transient adverse event (TAE), depending on severity. Complications are recognized as adverse events needing specific medical intervention and prolonged hospitalization, while TAEs are defined as transient injuries caused by shock waves, which required no medical intervention and do not prolong hospitalization.
次要结局
- the rate of pancreatic duct clearance(1 week)
- Pain relief of patients after P-ESWL and ERCP(more than 24 months)