ERCPERCPNCT07368335
Efficacy and Safety of a Novel ERCP Robot in the Treatment of Common Bile Duct Stone
A study testing Robotic-assisted ERCP and Conventional ERCP in people with ERCP and Robot Surgery, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Conventional endoscopic retrograde cholangiopancreatography (ERCP) is performed under fluoroscopic guidance, exposing endoscopists to ionizing radiation and posing risks of work-related musculoskeletal injury. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ERCP, Robot Surgery, Common Bile Duct Stone
- What is being tested?
- Robotic-assisted ERCP and Conventional ERCP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: Efficacy and Safety of Endoscopic Treatment in Common Bile Duct Stone Based on the Electronic Endoscopic Surgery System: A Prospective, Multicenter, Randomized Controlled Trial
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
- Being tested
- Robotic-assisted ERCP, Conventional ERCP
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted ERCPDevice
This group will receive endoscopic common bile duct lithotomy using the Electronic Endoscopic Surgery System produced by Shanghai Aohua Endoscopy Co., Ltd.
Conventional ERCPDevice
This group will undergo conventional endoscopic common bile duct lithotomy with a regular electronic duodenoscope.
| Study group | Role | What they receive |
|---|---|---|
| Conventional ERCP group | Active comparator | This group will undergo conventional endoscopic common bile duct lithotomy with a regular electronic duodenoscope. Receives: Device: Conventional ERCP |
| Robotic-assisted ERCP group | Experimental | Not described Receives: Device: Robotic-assisted ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bile duct stone extraction success
Stone extraction success was defined as complete clearance of the common bile duct during the same procedure.
Measured: Baseline
Rate of adverse events
Measured: Through study completion, an average of 1 month
Secondary outcomes (8)
Rate of biliary cannulation success
Biliary cannulation success was defined as achievement of deep biliary access.
Measured: 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.
Measured: Baseline
Intraoperative radiation exposure time and radiation exposure dose of the principal operating investigator
Measured: Baseline
Success rate of external drainage
Measured: Baseline
Success rate of pancreatic duct stent placement
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start24 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCPStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368335
- Sponsor's protocol ID
- 2025-0910-02
- Other IDs
- 20251106
- Acronym
- ERCP
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endoscopic Treatment in Common Bile Duct Stone Based on the Electronic Endoscopic Surgery System: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07368335
- Acronym / sponsor ID
- ERCP / 2025-0910-02
- Conditions
- ERCP, Robot Surgery, Common Bile Duct Stone
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ERCP group | Active comparator | Device: Conventional ERCPThis group will undergo conventional endoscopic common bile duct lithotomy with a regular electronic duodenoscope. |
| Robotic-assisted ERCP group | Experimental | Device: Robotic-assisted ERCP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted ERCPThis group will receive endoscopic common bile duct lithotomy using the Electronic Endoscopic Surgery System produced by Shanghai Aohua Endoscopy Co., Ltd. | Device | Robotic-assisted ERCP group |
| Conventional ERCPThis group will undergo conventional endoscopic common bile duct lithotomy with a regular electronic duodenoscope. | Device | Conventional ERCP group |
Primary outcome
Rate of bile duct stone extraction success
Time frame: Baseline
Stone extraction success was defined as complete clearance of the common bile duct during the same procedure.
Rate of adverse events
Time frame: Through study completion, an average of 1 month
8 secondary outcomes
Rate of biliary cannulation success
Time frame: Baseline
Procedure time, including papilla localization time, cannulation time and stone extraction time
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
Time frame: Baseline
Evaluation of System Performance
Time frame: Baseline
Operational Comfort and Satisfaction Scores
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for ERCP
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
RecruitingPhase 3
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Post ERCP Pancreatitis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted ERCP and Conventional ERCP in people with ERCP and Robot Surgery, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of bile duct stone extraction success (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.