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

N/AActive Not RecruitingNCT07368335

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

ERCP Robot Surgery Common Bile Duct Stone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Rate of bile duct stone extraction success

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

Time frame: Baseline

Rate of adverse events

Time frame: Through study completion, an average of 1 month

Secondary Outcomes

Rate of biliary cannulation success

Biliary cannulation success was defined as achievement of deep biliary access.

Time frame: Baseline

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

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.

Time frame: Baseline

Intraoperative radiation exposure time and radiation exposure dose of the principal operating investigator

Time frame: Baseline

Success rate of external drainage

Time frame: Baseline

Success rate of pancreatic duct stent placement

Time frame: Baseline

Rate of intraoperative conversion

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.

Time frame: Baseline

Evaluation of System Performance

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.

Time frame: Baseline

Operational Comfort and Satisfaction Scores

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.

Time frame: Baseline

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes