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临床试验/NCT05186350
NCT05186350已完成不适用

Comparison of SpyGlass Guided Lithotripsy Versus Extracorporeal Shockwaves Lithotripsy for Large Common Bile Duct Stones

First People's Hospital of Hangzhou1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Clearance rate(percentage)

研究概览

简要总结

Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for choledocholithiasis is a big problem, especially for stones with a diameter greater than 3cm. After ERCP failure, surgery was the option but patients not suitable for surgery were treated through stenting but had to undergo multiple ERCPs and show a success rate of only 44-96%. Recently, choledochoscopic laser, electrohydraulic lithotripsy, SpyGlass, or extracorporeal shock wave lithotripsy (ESWL) have been applied for the treatment of huge bile duct stones. The present study aims to compare the efficacy and safety outcomes of SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large bile 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 biliary calculi. It has the advantages of simple operation, low 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. So SpyGlass-guided laser lithotripsy is used. 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. The investigators conducted the current study to compare the therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large bile duct stones

研究设计

研究类型
Interventional
分配方式
Non 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

入选标准

  • large bile duct stones (≥10 mm)

排除标准

  • pregnancy
  • refusal of written informed consent
  • Patients with benign or malignant biliary stricture
  • Contraindications to ERCP exist
  • Complicated with acute pancreatitis or acute cholangitis
  • Coagulation dysfunction#thrombocytopenia
  • Patients after gastrointestinal reconstruction

结局指标

主要结局

Clearance rate(percentage)

时间窗: 1 month

Stone clearance ratio

Number of sessions

时间窗: 1 month

Number of ERCP procedures

次要结局

  • Procedure Time(Intraoperative)
  • Complications(1 month)

研究者

发起方
First People's Hospital of Hangzhou
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianfeng Yang

Professor

First People's Hospital of Hangzhou

研究点 (1)

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