Who is sponsoring NCT05429203?

NCT05429203 is sponsored by Stanford University.

What drugs are being tested in NCT05429203?

Interventions in NCT05429203: Duodenoscope with single-use distal cover, Conventional duodenoscope.

What condition does NCT05429203 study?

NCT05429203 studies Biliary Disease, Pancreatic Disease, Choledocholithiasis, Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Neoplasms.

Is NCT05429203 still recruiting?

NCT05429203 is currently completed. Last updated 15 September 2025.

Are results published for NCT05429203?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-09-15 · How we verify

NCT05429203

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

Completed NA Results posted Last updated 15 September 2025

What this trial tests

NA trial testing Duodenoscope with single-use distal cover in Biliary Disease in 319 participants. Completed in 29 July 2024.

Timeline

25 October 2022

Primary endpoint
29 July 2024

29 July 2024

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	319
Start date	25 October 2022
Primary completion	29 July 2024
Estimated completion	29 July 2024
Sites	1 location across United States

Drugs / interventions tested

Duodenoscope with single-use distal cover
Conventional duodenoscope

Conditions studied

Biliary Disease — all drugs for Biliary Disease →
Pancreatic Disease — all drugs for Pancreatic Disease →
Choledocholithiasis — all drugs for Choledocholithiasis →
Biliary Obstruction — all drugs for Biliary Obstruction →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Biliary Disease or Pancreatic Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Procedure-related Adverse Events Primary · 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.

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	8
Conventional Reusable Duodenoscope	9

Duodenoscope Maneuverability: Intubation Into Esophagus Secondary · Maneuverability will be assessed only during the procedure (approximately 10 minutes)

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.

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	153
Conventional Reusable Duodenoscope	154

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	5
Conventional Reusable Duodenoscope	5

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	1
Conventional Reusable Duodenoscope	1

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Duodenoscope Maneuverability: Passage Into Stomach Secondary · Maneuverability will be assessed only during the procedure (approximately 10 minutes)

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	153
Conventional Reusable Duodenoscope	155

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	3
Conventional Reusable Duodenoscope	2

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	3
Conventional Reusable Duodenoscope	2

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	1

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Duodenoscope Maneuverability: Navigation Across Pylorus Secondary · Maneuverability will be assessed only during the procedure (approximately 10 minutes)

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	151
Conventional Reusable Duodenoscope	155

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	3
Conventional Reusable Duodenoscope	4

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	1
Conventional Reusable Duodenoscope	1

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	2
Conventional Reusable Duodenoscope	0

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	2
Conventional Reusable Duodenoscope	0

Duodenoscope Maneuverability: Achieving Short Position of the Scope Secondary · Maneuverability will be assessed only during the procedure (approximately 10 minutes)

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	154
Conventional Reusable Duodenoscope	155

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	3
Conventional Reusable Duodenoscope	4

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	2
Conventional Reusable Duodenoscope	1

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Duodenoscope Maneuverability: Achieving Optimal Papillary Position Secondary · Maneuverability will be assessed only during the procedure (approximately 10 minutes)

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	154
Conventional Reusable Duodenoscope	154

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	4
Conventional Reusable Duodenoscope	4

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	1
Conventional Reusable Duodenoscope	2

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Duodenoscope Mechanical Characteristics Profile: Scope Stiffness Secondary · Mechanical characteristics assessed only during the procedure (approximately 15 minutes)

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.

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	155
Conventional Reusable Duodenoscope	155

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	4
Conventional Reusable Duodenoscope	5

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality Secondary · Mechanical characteristics assessed only during the procedure (approximately 15 minutes)

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.

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	155
Conventional Reusable Duodenoscope	156

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	3
Conventional Reusable Duodenoscope	4

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	1
Conventional Reusable Duodenoscope	0

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency Secondary · Mechanical characteristics assessed only during the procedure (approximately 15 minutes)

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	157
Conventional Reusable Duodenoscope	158

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	1
Conventional Reusable Duodenoscope	2

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	1
Conventional Reusable Duodenoscope	0

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Duodenoscope Mechanical Characteristics Profile: Hand Strain Secondary · Mechanical characteristics assessed only during the procedure (approximately 15 minutes)

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.

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	157
Conventional Reusable Duodenoscope	158

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	2
Conventional Reusable Duodenoscope	2

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Duodenoscope Imaging Characteristics Profile: Image Quality Secondary · Imaging characteristics were assessed only during the procedure (approximately 15 minutes)

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.

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	154
Conventional Reusable Duodenoscope	154

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	4
Conventional Reusable Duodenoscope	4

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	1
Conventional Reusable Duodenoscope	2

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Duodenoscope Imaging Characteristics Profile: Image Stability Secondary · Imaging characteristics were assessed only during the procedure (approximately 15 minutes)

Rating = 1

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	156
Conventional Reusable Duodenoscope	157

Rating = 2

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	3
Conventional Reusable Duodenoscope	3

Rating = 3

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 4

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Rating = 5

Group	Value	95% CI
Duodenoscope With Disposable Distal End Caps	0
Conventional Reusable Duodenoscope	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Duodenoscope With Disposable Distal End Caps

Serious: 8/159 (5%)

Deaths: 1/159

Conventional Reusable Duodenoscope

Serious: 9/160 (6%)

Deaths: 0/160

Serious adverse events (5 terms)

Reaction	System	Duodenoscope With Disposab…	Conventional Reusable Duod…
Post ERCP pancreatitis (PEP)	Gastrointestinal disorders	—	—
Post-sphincterotomy bleeding	Surgical and medical procedures	—	—
Cholangitis	Hepatobiliary disorders	—	—
Perforation	Surgical and medical procedures	—	—
Liver failure	Hepatobiliary disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Duodenoscope With Disposab…	Conventional Reusable Duod…
Abdomen pain (without post-ERCP pancreatitis)	Gastrointestinal disorders	—	—

Most-reported serious reactions: Post ERCP pancreatitis (PEP), Post-sphincterotomy bleeding, Cholangitis, Perforation, Liver failure.

Data from ClinicalTrials.gov NCT05429203 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Biliary Disease

Currently open trials in the same condition.

NCT06860984 — Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatograph · Phase 3 · recruiting
NCT04259580 — Calgary Registry for Advanced and Therapeutic Endoscopy · recruiting

Other Stanford University trials

Trials by the same sponsor.

NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
NCT04225949 — Patients Understanding of PROM Graphs · NA · withdrawn
NCT06273098 — School-Based Bladder Health Intervention · NA · withdrawn
NCT04652635 — Management of Nailbed Injuries · NA · withdrawn
NCT05443503 — Stanford Spine Keeper - Managing Your Low Back Pain · NA · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05429203 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stanford University
Last refreshed: 15 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05429203.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05429203

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (5 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Biliary Disease

Other Stanford University trials

Verify against primary sources