Efficacy and Safety of a Novel ERCP Robot in the Treatment of Common Bile Duct Stone (NCT07368335) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy and Safety of a Novel ERCP Robot in the Treatment of Common Bile Duct Stone
China200 participantsStarted 2025-12-24
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Aged 18 to 80 years, inclusive.
✓. Diagnosed with common bile duct stones based on symptoms, signs, laboratory tests, and imaging examinations, and deemed suitable by the investigator for endoscopic common bile duct stone removal (lithotomy).
✓. Willing to comply with all study procedures; able to understand the study purpose, and voluntarily provide written informed consent.
Exclusion criteria
✕. Severe cardiac, pulmonary, renal, or hepatic insufficiency, or mental disorders.
✕. Active viral hepatitis.
✕. Upper gastrointestinal stenosis, obstruction, or any condition preventing endoscopic access to the descending duodenum.
✕. Known intolerance to anesthetics or hypersensitivity to contrast agents.
✕. Non-lithogenic obstructive acute pancreatitis or acute exacerbation of chronic pancreatitis.
✕. Pregnant or lactating women.
What they're measuring
1
Rate of bile duct stone extraction success
Timeframe: Baseline
2
Rate of adverse events
Timeframe: Through study completion, an average of 1 month
Trial details
NCT IDNCT07368335
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School