Clinical Research Directory

Efficacy and Safety of a Novel ERCP Robot in the Treatment of Common Bile Duct Stone

Conventional endoscopic retrograde cholangiopancreatography (ERCP) is performed under fluoroscopic guidance, exposing endoscopists to ionizing radiation and posing risks of work-related musculoskeletal injury. Robotic-assisted ERCP may mitigate these occupational hazards and potentially enhance procedural precision and stability. However, robust clinical evidence regarding its performance and safety remains limited. This prospective, multicenter, randomized controlled non-inferiority trial is designed to evaluate the efficacy and safety of an ERCP robotic system (Electronic Endoscopic Surgery System) developed by Shanghai Aohua Photoelectricity Endoscope Co., Ltd. for common bile duct stone removal. A total of at least 200 subjects will be recruited and randomized 1:1 to either the experimental group or the control group. The experimental group will undergo robotic-assisted ERCP lithotomy using the aforementioned system, while the control group will receive conventional ERCP lithotomy using a standard duodenoscope.

Laser vs Electrohydraulic Lithotripsy for Difficult CBD Stones

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.