An interventional study of Duodenoscope with single-use distal cover and Conventional duodenoscope in Biliary Disease, Pancreatic Disease and Choledocholithiasis, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Stanford University · Not applicable, Interventional, and Other
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.
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.
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This study's enrollment of 319 is above the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.
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Exclusion Criteria:
Patients will undergo ERCP using a duodenoscope with a single-use distal cover
Device: Duodenoscope with single-use distal cover
Patients will undergo ERCP using a conventional duodenoscope
Device: Conventional duodenoscope
Newer duodenoscope with a single-use distal cover
Conventional duodenoscope with standard methods of reprocessing
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.
Time frame: 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30-60 minutes
| Milestone | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Started | 159 | 160 |
| Completed | 159 | 160 |
| Not completed | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Number of Participants With Procedure-related Adverse Events | 8 | 9 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 153 | 154 |
| Rating = 2 | 5 | 5 |
| Rating = 3 | 1 | 1 |
| Rating = 4 | 0 | 0 |
| Rating = 5 | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 153 | 155 |
| Rating = 2 | 3 | 2 |
| Rating = 3 | 3 | 2 |
| Rating = 4 | 0 | 1 |
| Rating = 5 | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 151 | 155 |
| Rating = 2 | 3 | 4 |
| Rating = 3 | 1 | 1 |
| Rating = 4 | 2 | 0 |
| Rating = 5 | 2 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 154 | 155 |
| Rating = 2 | 3 | 4 |
| Rating = 3 | 2 | 1 |
| Rating = 4 | 0 | 0 |
| Rating = 5 | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 154 | 154 |
| Rating = 2 | 4 | 4 |
| Rating = 3 | 1 | 2 |
| Rating = 4 | 0 | 0 |
| Rating = 5 | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 155 | 155 |
| Rating = 2 | 4 | 5 |
| Rating = 3 | 0 | 0 |
| Rating = 4 | 0 | 0 |
| Rating = 5 | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 155 | 156 |
| Rating = 2 | 3 | 4 |
| Rating = 3 | 1 | 0 |
| Rating = 4 | 0 | 0 |
| Rating = 5 | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 157 | 158 |
| Rating = 2 | 1 | 2 |
| Rating = 3 | 1 | 0 |
| Rating = 4 | 0 | 0 |
| Rating = 5 | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 157 | 158 |
| Rating = 2 | 2 | 2 |
| Rating = 3 | 0 | 0 |
| Rating = 4 | 0 | 0 |
| Rating = 5 | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 154 | 154 |
| Rating = 2 | 4 | 4 |
| Rating = 3 | 1 | 2 |
| Rating = 4 | 0 | 0 |
| Rating = 5 | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Rating = 1 | 156 | 157 |
| Rating = 2 | 3 | 3 |
| Rating = 3 | 0 | 0 |
| Rating = 4 | 0 | 0 |
| Rating = 5 | 0 | 0 |
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.
| Participants | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Number of Participant With Procure Success (Ability to Perform Interventions) | 154 | 155 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duodenoscope With Disposable Distal End Caps | 1/159 (0.6%) | 8/159 (5%) | 8/159 (5%) |
| Conventional Reusable Duodenoscope | 0/160 (0%) | 9/160 (5.6%) | 8/160 (5%) |
| Event | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Post ERCP pancreatitis (PEP)Gastrointestinal disorders | 6/159 | 5/160 |
| Post-sphincterotomy bleedingSurgical and medical procedures | 1/159 | 3/160 |
| CholangitisHepatobiliary disorders | 1/159 | 1/160 |
| PerforationSurgical and medical procedures | 1/159 | 1/160 |
| Liver failureHepatobiliary disorders | 1/159 | 0/160 |
| Event | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope |
|---|---|---|
| Abdomen pain (without post-ERCP pancreatitis)Gastrointestinal disorders | 8/159 | 8/160 |
| Age, Continuous(years) | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope | Total |
|---|---|---|---|
| Median | 64.5 (48 to 72.7) | 65 (52 to 72.5) | 65 (50 to 73) |
| Sex: Female, Male(Participants) | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope | Total |
|---|---|---|---|
| Female | 56 | 74 | 130 |
| Male | 103 | 86 | 189 |
| Race (NIH/OMB)(Participants) | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 41 | 48 | 89 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 27 | 33 | 60 |
| White | 75 | 62 | 137 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 16 | 17 | 33 |
| Region of Enrollment(Participants) | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope | Total |
|---|---|---|---|
| United States | 159 | 160 | 319 |
| Previous ERCP(Participants) | Duodenoscope With Disposable Distal End Caps | Conventional Reusable Duodenoscope | Total |
|---|---|---|---|
| Index | 45 | 44 | 89 |
| Repeat | 114 | 116 | 230 |
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