Common Bile Duct Stone, ERCP, Robot Surgery
Conditions
Brief 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.
Interventions
DEVICERobotic-assisted ERCP
This group will receive endoscopic common bile duct lithotomy using the Electronic Endoscopic Surgery System produced by Shanghai Aohua Endoscopy Co., Ltd.
DEVICEConventional ERCP
This group will undergo conventional endoscopic common bile duct lithotomy with a regular electronic duodenoscope.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse events | Through study completion, an average of 1 month | — |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative radiation exposure time and radiation exposure dose of the principal operating investigator | Baseline | — |
| Success rate of external drainage | Baseline | — |
| Success rate of pancreatic duct stent placement | Baseline | — |
| Rate of intraoperative conversion | Baseline | It is defined as the proportion of subjects who switched from endoscopic common bile duct lithotomy using the investigational device to other treatment modalities during the operation. |
| Evaluation of System Performance | Baseline | The performance of the intraoperative investigational device was evaluated by the principal operating investigators using a three-grade rating system (Excellent, Good, Fair), following the procedures below: A three-grade rating system (Excellent, Good, Fair) was adopted for the evaluation. Three principal operating investigators from 3 clinical centers conducted independent evaluations based on the Evaluation Indicators and Criteria, respectively. The evaluation results are filled in the Evaluation Form for Surgical Procedure and Device Coordination. |
| Rate of biliary cannulation success | Baseline | Biliary cannulation success was defined as achievement of deep biliary access. |
| Operational Comfort and Satisfaction Scores | Baseline | This score is obtained through a questionnaire-based approach, and the questionnaire is designed to collect the comfort level and satisfaction degree ratings of the principal operating investigators (10 items in total). Each item is scored on a 1-5 scale, with scores ranging from 1 to 5 from left to right. The scoring definitions are as follows: 1 point for Strongly Agree; 2 points for Agree; 3 points for Neutral; 4 points for Disagree; 5 points for Strongly Disagree. A lower score indicates a better experience and higher satisfaction of the investigators with the use of the investigational device. |
| Procedure time, including papilla localization time, cannulation time and stone extraction time | Baseline | Papilla localization time was defined as the time required from insertion of the duodenoscope to accurate identification of the major duodenal papilla. Cannulation time was defined as the interval from first contact between the papilla and a wire-guided sphincterotome to successful deep biliary access. Stone extraction time was defined as the duration from successful biliary cannulation to complete stone removal, confirmed endoscopically and fluoroscopically. Total procedure time was measured from insertion of the duodenoscope into the esophagus to completion of all planned ERCP interventions. |
Countries
China
Outcome results
None listed