跳至主要内容
临床试验/NCT05888077
NCT05888077尚未招募不适用

Extracorporeal Shock Wave Lithotripsy Using Latest Lithotripter and Laser Lithotripsy for Difficult Bile Duct Stones

Asian Institute of Gastroenterology, India0 个研究点目标入组 450 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
450
主要终点
Efficacy ESWL and Laser lithotripsy

研究概览

简要总结

When conventional endoscopic treatment of bile duct stones is impossible or fails, advanced endoscopy assisted lithotripsy can be performed by electrohydraulic lithotripsy (EHL), laser lithotripsy, or extracorporeal shock wave lithotripsy (ESWL). No systematic review has compared efficacy and safety between these techniques.

详细描述

Extracorporeal shock wave lithotripsy (ESWL) and Laser Lithotripsy (LL) have emerged as alternate treatment options for difficult common bile duct (CBD) stones. There is limited data on efficacy and safety of the latest Dornier delta III lithotripter. This study examined the efficacy of ESWL by Dornier delta III & Laser lithotripsy in terms of stone clearance rate, number of sessions required and safety in a large cohort of patients.

The initial lithotripter models used electrohydraulic energy and required general anesthesia, prone positioning, and water immersion. High clearance rates were reported, but newer models were then developed with use of electromagnetic coils, better focussing, use of a water cushion instead of water immersion, use of ultrasound and then later of digitalised X ray for localisation. The ductal clearance of ESWL is upto 90%. Known complications of this procedure are cholangitis and pancreatitis which occur at the rate of 9-14% apart from minor adverse effects such as pain and local hematoma formation. In a single randomised study that compared intracorporeal lithotripsy(ILL) versus extracorporeal lithotripsy, ILL was found more effective than ESWL in terms of stone clearance rate and treatment duration. However, the lithotripters used in the previous studies were of previous generations, and also commonly used for kidney stones as well. The current study is the first to use the Dornier delta III for the same.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with stones that could not be extracted by conventional methods such as biliary sphincterotomy, balloon, basket or mechanical lithotripsy.
  • Patients with biliary stones larger than 15mm.
  • Intrahepatic or cystic duct stones.

排除标准

  • Pregnancy.
  • Coagulopathy which cannot be corrected.
  • Ongoing cholangitis.

结局指标

主要结局

Efficacy ESWL and Laser lithotripsy

时间窗: One year

Efficacy of ESWL by Dornier delta III \& Laser lithotripsy in terms of stone clearance rate

次要结局

未报告次要终点

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Sponsor

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