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

Nanjing University

Status: Active, not recruiting

Conditions: Common Bile Duct Stone; ERCP; Robot Surgery

Treatments: Device: Conventional ERCP; Device: Robotic-assisted ERCP

Study type: Interventional

Funder types: Other

Identifiers

NCT07368335

2025-0910-02

20251106 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Conventional ERCP group

Active Comparator group

Description:

This group will undergo conventional endoscopic common bile duct lithotomy with a regular electronic duodenoscope.

Treatment:

Device: Conventional ERCP

Robotic-assisted ERCP group

Experimental group

Treatment:

Device: Robotic-assisted ERCP