NCT07368335

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

Efficacy and Safety of Endoscopic Treatment in Common Bile Duct Stone Based on the Electronic Endoscopic Surgery System: A Prospective, Multicenter, Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• ERCP
• Robot Surgery
• Common Bile Duct Stone

Interventions

Type	Name	Description
DEVICE	Robotic-assisted ERCP	This group will receive endoscopic common bile duct lithotomy using the Electronic Endoscopic Surgery System produced by Shanghai Aohua Endoscopy Co., Ltd.
DEVICE	Conventional ERCP	This group will undergo conventional endoscopic common bile duct lithotomy with a regular electronic duodenoscope.

Timeline

• Start date: 2025-12-24
• Primary completion: 2026-12-01
• Completion: 2026-12-30
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: China