Biliary DiseaseNCT05429203
Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope
A study testing Duodenoscope with single-use distal cover and Conventional duodenoscope in people with Biliary Disease and Pancreatic Disease, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Disease, Pancreatic Disease, Choledocholithiasis
- What is being tested?
- Duodenoscope with single-use distal cover and Conventional duodenoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing ERCP for biliary and pancreatic conditions
- Age > 18 years old
Who cannot join
- Vulnerable patient groups including pregnant women
- Patients who are unable to consent
- Patients with known cholangitis
- Patients with known Carbapenem-Resistant Enterobacteriaceae (CRE) or any other multi-drug resistant organisms (MDRO) infection
- Surgically altered anatomy except for Billroth I
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Outcomes in Patients Undergoing Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) Using Duodenoscope With Single-use Distal Cover and Conventional Reusable Duodenoscope: A Randomized Controlled Trial
The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.
Read the detailed description
The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.
- Conditions
- Biliary Disease, Pancreatic Disease, Choledocholithiasis, Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Neoplasms
- Being tested
- Duodenoscope with single-use distal cover, Conventional duodenoscope
- Keywords
- ERCP, Duodenoscope, Duodenoscope with single-use distal cover
- Medical subject headings
- Gallbladder Diseases, Pancreatic Diseases, Choledocholithiasis, Biliary Tract Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duodenoscope with single-use distal coverDevice
Newer duodenoscope with a single-use distal cover
Conventional duodenoscopeDevice
Conventional duodenoscope with standard methods of reprocessing
| Study group | Role | What they receive |
|---|---|---|
| Duodenoscope with single-use distal cover | Active comparator | Patients will undergo ERCP using a duodenoscope with a single-use distal cover Receives: Device: Duodenoscope with single-use distal cover |
| Conventional Duodenoscope | Active comparator | Patients will undergo ERCP using a conventional duodenoscope Receives: Device: Conventional duodenoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedure-related Adverse Events
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes were assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.
Measured: 3 months
Secondary outcomes (12)
Duodenoscope Maneuverability: Intubation Into Esophagus
Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Measured: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Duodenoscope Maneuverability: Passage Into Stomach
Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Measured: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Duodenoscope Maneuverability: Navigation Across Pylorus
Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Measured: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Duodenoscope Maneuverability: Achieving Short Position of the Scope
Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Measured: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Duodenoscope Maneuverability: Achieving Optimal Papillary Position
Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Measured: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Duodenoscope Mechanical Characteristics Profile: Scope Stiffness
Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Measured: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)
Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality
Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being no water leakage or no difficulty in applying suction or inflating air, 2 minimal leakage or minimal difficulty with suction or inflation, 3 moderate leakage or difficulty, 4 severe leakage or difficulty and 5 unable to perform the requisite function.
Measured: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)
Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency
Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Measured: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)
Duodenoscope Mechanical Characteristics Profile: Hand Strain
Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being no strain, 2 minimal strain, 3 moderate strain, 4 severe strain and 5 unable to complete the procedure.
Measured: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)
Duodenoscope Imaging Characteristics Profile: Image Quality
Providers assessed the 2 duodenoscopes for their imaging characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being superior, 2 good, 3 satisfactory, 4 suboptimal and 5 unable to visualize or achieve stability of image resulting in termination of procedure.
Measured: Imaging characteristics were assessed only during the procedure (approximately 15 minutes)
Duodenoscope Imaging Characteristics Profile: Image Stability
Providers assessed the 2 duodenoscopes for their imaging characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being superior, 2 good, 3 satisfactory, 4 suboptimal and 5 unable to visualize or achieve stability of image resulting in termination of procedure.
Measured: Imaging characteristics were assessed only during the procedure (approximately 15 minutes)
Number of Participant With Procure Success (Ability to Perform Interventions)
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their ability to perform endoscopic maneuvers like sphincterotomy, balloon sweep, use of basket/mechanical lithotriptor, stone clearance, stricture dilation using balloon/catheter, stent insertion, stent removal and use of single operator cholangioscopy/pancreatoscopy.
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start25 Oct 2022
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhas Banerjee, Stanford University
- Investigators
- Subhas Banerjee, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429203
- Sponsor's protocol ID
- 65189
- Status last verified
- Aug 2025
- First submitted
- 17 Jun 2022
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bang JY, Rosch T, Kim HM, Thakkar S, Robalino Gonzaga E, Tharian B, Inamdar S, Lee LS, Yachimski P, Jamidar P, Muniraj T, DiMaio C, Kumta N, Sethi A, Draganov P, Yang D, Seoud T, Perisetti A, Bondi G, Kirtane S, Hawes R, Wilcox CM, Kozarek R, Reddy DN, Varadarajulu S. Prospective evaluation of an assessment tool for technical performance of duodenoscopes. Dig Endosc. 2021 Jul;33(5):822-828. doi: 10.1111/den.13856. Epub 2020 Nov 17.
PubMed 33007136
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes in Patients Undergoing Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) Using Duodenoscope With Single-use Distal Cover and Conventional Reusable Duodenoscope: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05429203
- Acronym / sponsor ID
- 65189
- Conditions
- Biliary Disease, Pancreatic Disease, Choledocholithiasis, Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Neoplasms
- Keywords
- ERCP, Duodenoscope, Duodenoscope with single-use distal cover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.
Detailed description
The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duodenoscope with single-use distal cover | Active comparator | Device: Duodenoscope with single-use distal coverPatients will undergo ERCP using a duodenoscope with a single-use distal cover |
| Conventional Duodenoscope | Active comparator | Device: Conventional duodenoscopePatients will undergo ERCP using a conventional duodenoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing ERCP for biliary and pancreatic conditions
- Age > 18 years old
Key exclusion criteria (5 listed)
- Vulnerable patient groups including pregnant women
- Patients who are unable to consent
- Patients with known cholangitis
- Patients with known Carbapenem-Resistant Enterobacteriaceae (CRE) or any other multi-drug resistant organisms (MDRO) infection
- Surgically altered anatomy except for Billroth I
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 |
|---|---|---|
| Duodenoscope with single-use distal coverNewer duodenoscope with a single-use distal cover | Device | Duodenoscope with single-use distal cover |
| Conventional duodenoscopeConventional duodenoscope with standard methods of reprocessing | Device | Conventional Duodenoscope |
Primary outcome
Number of Participants With Procedure-related Adverse Events
Time frame: 3 months
Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes were assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.
12 secondary outcomes
Duodenoscope Maneuverability: Intubation Into Esophagus
Time frame: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Duodenoscope Maneuverability: Passage Into Stomach
Time frame: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Duodenoscope Maneuverability: Navigation Across Pylorus
Time frame: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Duodenoscope Maneuverability: Achieving Short Position of the Scope
Time frame: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Duodenoscope Maneuverability: Achieving Optimal Papillary Position
Time frame: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Duodenoscope Mechanical Characteristics Profile: Scope Stiffness
Time frame: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)
Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality
Time frame: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)
Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency
Time frame: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)
Duodenoscope Mechanical Characteristics Profile: Hand Strain
Time frame: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)
Duodenoscope Imaging Characteristics Profile: Image Quality
Time frame: Imaging characteristics were assessed only during the procedure (approximately 15 minutes)
Duodenoscope Imaging Characteristics Profile: Image Stability
Time frame: Imaging characteristics were assessed only during the procedure (approximately 15 minutes)
Number of Participant With Procure Success (Ability to Perform Interventions)
Time frame: 30-60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33007136Bang JY, Rosch T, Kim HM, Thakkar S, Robalino Gonzaga E, Tharian B, Inamdar S, Lee LS, Yachimski P, Jamidar P, Muniraj T, DiMaio C, Kumta N, Sethi A, Draganov P, Yang D, Seoud T, Perisetti A, Bondi G, Kirtane S, Hawes R, Wilcox CM, Kozarek R, Reddy DN, Varadarajulu S. Prospective evaluation of an assessment tool for technical performance of duodenoscopes. Dig Endosc. 2021 Jul;33(5):822-828. doi: 10.1111/den.13856. Epub 2020 Nov 17.
- Individual participant dataSharing planned: No
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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.
Subhas Banerjee, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duodenoscope with single-use distal cover and Conventional duodenoscope in people with Biliary Disease and Pancreatic Disease, run by Stanford University at 1 site in United States.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 15 Sep 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Procedure-related Adverse Events (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05429203, which also lists 1 linked publication.
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 15 Sep 2025.