Spyglass-guided Lithotripsy Vs ESWL for Pancreatic Duct Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for pancreatic duct stones is a amjor problem, especially bigger size stones. After ERCP failure, surgery was the only option but patients not suitable for surgery were treated through stenting. But had to undergo multiple ERCPs and show lower success rate. Recently, SpyGlass and extracorporeal shock wave lithotripsy (ESWL) have been applied for the treatment of huge stones. The present study aims to compare the efficacy and safety outcomes of SpyGlass-guided lithotripsy and ESWL procedures for the removal of pancreatic duct stones.
详细描述
ESWL was first used for the removal of renal calculi and ureteral calculi however, now a day is being used for pancreatic duct stones and biliary calculi. It has the advantages of simple operation, lower cost, and higher safety. Recent studies show that the procedure time for ESWL is also shorter and the utilization rate of mechanical lithotripsy was effectively reduced with fewer complications. But It is difficult for ESWL to break the stones larger than 3cm into small pieces.
Spyglass has been used in clinics for more than ten years. Recently, a study reported difficult bile duct stones that were treated with SpyGlass-guided laser lithotripsy that shows promising results. Compared with laser lithotripsy under X-ray monitoring, there is no significant difference in stone removal rate and complication rate between the two methods. However, the effect of lithotripsy under Spyglass direct vision is better, which can break large stones into smaller pieces, thus making it easier to take stones. Investigator conducted the current study to compare the therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large pancreatic duct stones.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreatic duct sone
- •Falied to eliminate through ERCP only
排除标准
- •Pregnancy
- •Refusal of written informed consent
- •Patients not suitable for ESWL/ Spyglass
- •Contraindications to ERCP exist
- •Complicated with acute pancreatitis or acute cholangitis
- •Coagulation dysfunction#thrombocytopenia
- •Patients after gastrointestinal reconstruction
- •Allergic to drugs
研究组 & 干预措施
Spyglass group
lithotripsy through Spyglass and ERCP
干预措施: Spyglass-guided lithotripsy (Procedure)
ESWL group
Lithotripsy through ESWL and ERCP
干预措施: ESWL (Procedure)
结局指标
主要结局
Clinical success
时间窗: 1 month
Pancreatic duct stone clearance rate
Technical success
时间窗: Intraoperative
Successfull intervention
次要结局
- Procedure sessions(1 month)
- Adverse events(1 month)
- Total number of ERCP(1 month)
研究者
Jianfeng Yang
Professor
First People's Hospital of Hangzhou
