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

NCT07368335 | Active Not Recruiting DMC

• 2 other identifiers: 2025-0910-0220251106
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

ERCP; Robot Surgery; Common Bile Duct Stone

Outcome Measures

Primary Outcomes (2)

• Rate of bile duct stone extraction success

  Stone extraction success was defined as complete clearance of the common bile duct during the same procedure.

  Baseline

• Rate of adverse events

  Through study completion, an average of 1 month

Secondary Outcomes (8)

• Rate of biliary cannulation success

  Baseline

• Procedure time, including papilla localization time, cannulation time and stone extraction time

  Baseline

• 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

Study Arms (2)

Conventional ERCP group

ACTIVE COMPARATOR

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

Device: Conventional ERCP

Robotic-assisted ERCP group

EXPERIMENTAL

Device: Robotic-assisted ERCP

Interventions

Robotic-assisted ERCP DEVICE

This group will receive endoscopic common bile duct lithotomy using the Electronic Endoscopic Surgery System produced by Shanghai Aohua Endoscopy Co., Ltd.

Robotic-assisted ERCP group

Conventional ERCP DEVICE

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

Conventional ERCP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Active peptic ulcer or upper gastrointestinal hemorrhage within one month prior to informed consent.
• Known severe bleeding tendency (coagulopathy).
• History of upper gastrointestinal reconstruction surgery resulting in altered anatomy.
• Previous endoscopic sphincterotomy of the duodenal papilla.
• Inability to cooperate with ERCP procedures.
• 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.
• 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).

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 26, 2026
• Study Start: December 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CN (1)