The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Phase
Not applicable
Started
2025-12-24
Last updated
2026-01-26
Condition(s) studied
ERCPRobot SurgeryCommon Bile Duct Stone
Investigational drug(s) / intervention(s)
Robotic-assisted ERCPConventional ERCP
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.
Conventional ERCP: This group will undergo conventional endoscopic common bile duct lithotomy with a regular electronic duodenoscope.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Aged 18 to 80 years, inclusive.
2. 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).
3. Willing to comply with all study procedures; able to understand the study purpose, and voluntarily provide written informed consent.
Exclusion Criteria:
1. Severe cardiac, pulmonary, renal, or hepatic insufficiency, or mental disorders.
2. Active viral hepatitis.
3. Upper gastrointestinal stenosis, obstruction, or any condition preventing endoscopic access to the descending duodenum.
4. Known intolerance to anesthetics or hypersensitivity to contrast agents.
5. Non-lithogenic obstructive acute pancreatitis or acute exacerbation of chronic pancreatitis.
6. Pregnant or lactating women.
7. Active peptic ulcer or upper gastrointestinal hemorrhage within one month prior to informed consent.
8. Known severe bleeding tendency (coagulopathy).
9. History of upper gastrointestinal reconstruction surgery resulting in altered anatomy.
10. Previous endoscopic sphincterotomy of the duodenal papilla.
11. Inability to cooperate with ERCP procedures.
12. Participation in a drug clinical trial within the past 3 months, or in another medical device clinical trial (excluding non-interventional studies) within the past month.
13. Any other condition that, in the opinion of the investigator, may render the participant unsuitable for the trial (including but not limited to duodenal mucosal edema, papillary malformation, papillary surface ulcer, papillary fistula, or difficult-to-treat stones).
Primary outcome measure(s)
Rate of bile duct stone extraction success — Baseline Stone extraction success was defined as complete clearance of the common bile duct during the same procedure.
Rate of adverse events — Through study completion, an average of 1 month
Trial sites (1)
Facility
City
Region
Status
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing
Jiangsu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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