Efficacy and Safety of Laser Versus Electrohydraulic Lithotripsy for Difficult Biliary Stones: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Effectiveness of Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL)
研究概览
简要总结
Common bile duct (CBD) stones are a frequent condition that can lead to severe complications if not treated. The standard approach involves endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and stone extraction using balloons or baskets. However, approximately 10-15% of cases involve "difficult CBD stones" that cannot be removed using conventional methods.
According to the European Society of Gastrointestinal Endoscopy (ESGE), difficult CBD stones are characterized by large size (≥15 mm), impaction, multiple stones, difficult locations (e.g., intrahepatic or cystic ducts), or altered anatomy due to previous surgeries. These cases require advanced techniques such as single-operator cholangioscopy (SOC) using the SpyGlass DS system, which allows direct stone visualization and lithotripsy-assisted fragmentation.
Two primary lithotripsy methods are available:
Electrohydraulic Lithotripsy (EHL): Uses shock waves from electrical energy to break stones.
Laser Lithotripsy (LL): Uses laser energy to fragment stones through a water-mediated medium.
While both techniques are effective, studies suggest LL has a higher first-attempt stone clearance rate (82-100%) compared to EHL (70.9-75%). However, EHL is more cost-effective and widely available, whereas LL offers greater precision but at a higher cost. Currently, no randomized controlled trial (RCT) directly compares their efficacy, procedural time, complication rates, or operator satisfaction.
This study aims to fill that gap by conducting a randomized trial comparing EHL and LL in the treatment of difficult CBD stones. The primary outcome is the success rate of complete stone clearance in the first session, while secondary outcomes include procedural duration, post-procedural complications, and operator satisfaction.
The findings will provide critical evidence for optimizing endoscopic stone management, improving patient outcomes, and guiding healthcare resource allocation.
详细描述
Common bile duct (CBD) stones are a prevalent condition that can lead to severe complications if left untreated. The standard treatment method involves endoscopic retrograde cholangiopancreatography (ERCP) for stone removal. Conventional techniques include sphincterotomy combined with balloon or basket extraction. However, approximately 10-15% of patients present with "difficult CBD stones," which cannot be effectively removed using standard techniques.
The European Society of Gastrointestinal Endoscopy (ESGE) defines difficult CBD stones as those meeting one or more of the following criteria: stone size ≥15 mm, impacted stones, multiple stones, stones in difficult-to-access locations (e.g., intrahepatic or cystic ducts), barrel-shaped stones, or stones in patients with altered anatomy due to prior surgical interventions (e.g., Roux-en-Y reconstruction). These cases often require specialized techniques to achieve successful stone clearance while minimizing complications.
Intervention and Rationale:
Single-operator cholangioscopy using the SpyGlass system has become a widely adopted approach for managing difficult CBD stones. This technique enables direct visualization of the stone and facilitates lithotripsy, which fragments stones into smaller pieces for easier removal. The two primary lithotripsy techniques available are:
Electrohydraulic Lithotripsy (EHL): Uses shock waves generated by electrical energy transmitted through a probe to fragment 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >18 years
- •Difficult CBD stone
- •Large CBD stone (stone > 1.5 cm) or Stone impaction or CBD stones that were not completely removed using conventional techniques.
排除标准
- •Pregnancy
- •Unstable vital signs
- •Severe comorbidities
- •Uncorrected coagulopathy
- •Surgically altered anatomy
- •Unable to complete informed consent
研究组 & 干预措施
Laser Lithotripsy
干预措施: Laser Lithotripsy (Device)
Electrohydraulic Lithotripsy
干预措施: Electrohydraulic Lithotripsy (Device)
结局指标
主要结局
Effectiveness of Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL)
时间窗: During the procedure
Comparison of the effectiveness of Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL) by examining the success rate of complete stone removal on the first procedure.
次要结局
- Procedure time(Periprocedural (Total procedure time usually 1-2 hours))
- Number of catheters used(Periprocedural)
- Physician satisfaction(Periprocedural)
- Procedure-related adverse events(up to 2 weeks after the procedure)
- Length of hospital stay(through after procedure average 1-2 weeks)
研究者
Varayu Prachayakul
Associate Professor
Mahidol University