ESWL Combined With ERCP and Laser Lithotripsy Combined With ERCP In Treatment of Pancreatic Duct Stones With Chronic Pancreatitis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- technical success rates
研究概览
简要总结
This study will compare the efficacy of ESWL and Laser Lithotripsy in the treatment of pancreatic duct stones with ERCP.
详细描述
Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic Retrograde Cholangiopancreatography (ERCP) are the first choice. ERCP is effective in the treatment of pancreatic duct stones by using basket and/or balloon catheter. But in most cases, ERCP is only suitable for the treatment of pancreatic duct stones (diameter < 5mm) located in the head/body of the Pancreatic Duct (PD). PD stones larger than 5mm generally require Extracorporeal Shock Wave Lithotripsy (ESWL) or Endoscopic Intraductal Lithotripsy (EIL) for pretreatment. EIL includes Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL).
ESWL first locates the stone by X-ray, and then uses an electromagnetic pulse generator to direct a higher-energy shock wave to the stone, so that the stone is crushed by thousands of shock waves. The principle of laser lithotripsy is to make the stone absorb strong infrared rays and generate shock waves to achieve the purpose of fragmenting the stone.
In view of the fact that there is no relevant research comparing the overall efficacy of ESWL combined with ERCP and EIL combined with ERCP, it is necessary to evaluate the differences in the therapeutic effects and complications of the two for PD stones. This research helps to provide evidence-based medical evidence, guide physicians' clinical practice, improve the quality of patients' lives, and reduce the economic burden of patients.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic adult patients diagnosed with chronic pancreatitis and pancreatic duct stones;
- •at least one stone (>5 mm in diameter) located in the pancreatic duct of the head/body of the pancreas;
- •dilation of the proximal pancreatic duct.
排除标准
- •history of ERCP or ESWL treatment;
- •suspected to have malignant tumors;
- •history of pancreatic surgery or gastrojejunostomy (Billroth II);
- •pancreatic pseudocyst with a diameter >4cm;
- •bile duct stricture secondary to cholangitis or chronic pancreatitis;
- •acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis);
- •coagulation dysfunction (INR≥1.5 or platelet count≤50×10^9/L);
- •pregnant or breastfeeding women;
- •patients who refused to participate in the study.
结局指标
主要结局
technical success rates
时间窗: during ERCP procedure
Technical success rates refer to the successful completion of standard procedures or the occurrence of complete spontaneous stone removal.
clearance rates of pancreatic duct stones
时间窗: during ERCP procedure
Clearance rates have been defined as complete, partial, or failure if the proportion of stones cleared was \> 90%, 50% - 90%, or \< 50%, respectively.
次要结局
- postoperative complications(30 days after ERCP procedure)
- time taken to completely clear the stone(during ESWL and ERCP procedure)
- success rates of pancreatic duct decompression(during ERCP procedure)