N/A N=319 Randomized Double-blind Other

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

Biliary Disease · Pancreatic Disease · Choledocholithiasis · Biliary Obstruction · Biliary Tract Neoplasms

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View on ClinicalTrials.gov: NCT05429203 ↗

Enrolled (actual)

319

Serious AEs

5.3%

Results posted

Sep 2025

Primary outcome: Primary: Number of Participants With Procedure-related Adverse Events — 8; 9 Participants — p=0.8

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Duodenoscope with single-use distal cover (Device); Conventional duodenoscope (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Procedure-related Adverse Events	8; 9	0.8
SECONDARY Duodenoscope Maneuverability: Intubation Into Esophagus	153; 154; 5; 5; 1; 1	1
SECONDARY Duodenoscope Maneuverability: Passage Into Stomach	153; 155; 3; 2; 3; 2	0.7
SECONDARY Duodenoscope Maneuverability: Navigation Across Pylorus	151; 155; 3; 4; 1; 1	0.4
SECONDARY Duodenoscope Maneuverability: Achieving Short Position of the Scope	154; 155; 3; 4; 2; 1	0.8
SECONDARY Duodenoscope Maneuverability: Achieving Optimal Papillary Position	154; 154; 4; 4; 1; 2	0.8
SECONDARY Duodenoscope Mechanical Characteristics Profile: Scope Stiffness	155; 155; 4; 5; 0; 0	0.7
SECONDARY Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality	155; 156; 3; 4; 1; 0	0.6
SECONDARY Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency	157; 158; 1; 2; 1; 0	0.5
SECONDARY Duodenoscope Mechanical Characteristics Profile: Hand Strain	157; 158; 2; 2; 0; 0	0.9
SECONDARY Duodenoscope Imaging Characteristics Profile: Image Quality	154; 154; 4; 4; 1; 2	0.8
SECONDARY Duodenoscope Imaging Characteristics Profile: Image Stability	156; 157; 3; 3; 0; 0	0.9
SECONDARY Number of Participant With Procure Success (Ability to Perform Interventions)	154; 155	—

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. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.

Eligibility Criteria

Inclusion Criteria

Patients undergoing ERCP for biliary and pancreatic conditions
Age > 18 years old

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT05429203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.