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

NCT05429203 | Completed Results FDA Device

• 1 other identifier: 65189
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biliary Disease; Pancreatic Disease; Choledocholithiasis; Biliary Obstruction; Biliary Tract Neoplasms; Pancreatic Neoplasms

Keywords

ERCP; Duodenoscope; Duodenoscope with single-use distal cover

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (12)

• Duodenoscope Maneuverability: Intubation Into Esophagus

  Maneuverability will be assessed only during the procedure (approximately 10 minutes)

• Duodenoscope Maneuverability: Passage Into Stomach

  Maneuverability will be assessed only during the procedure (approximately 10 minutes)

• Duodenoscope Maneuverability: Navigation Across Pylorus

  Maneuverability will be assessed only during the procedure (approximately 10 minutes)

• Duodenoscope Maneuverability: Achieving Short Position of the Scope

  Maneuverability will be assessed only during the procedure (approximately 10 minutes)

• Duodenoscope Maneuverability: Achieving Optimal Papillary Position

  Maneuverability will be assessed only during the procedure (approximately 10 minutes)

Study Arms (2)

Duodenoscope with single-use distal cover

ACTIVE COMPARATOR

Patients will undergo ERCP using a duodenoscope with a single-use distal cover

Device: Duodenoscope with single-use distal cover

Conventional Duodenoscope

ACTIVE COMPARATOR

Patients will undergo ERCP using a conventional duodenoscope

Device: Conventional duodenoscope

Interventions

Duodenoscope with single-use distal cover DEVICE

Newer duodenoscope with a single-use distal cover

Duodenoscope with single-use distal cover

Conventional duodenoscope DEVICE

Conventional duodenoscope with standard methods of reprocessing

Conventional Duodenoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford hospital

Palo Alto, California, 943305, United States

Location

Related Publications (1)

• 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.

  PMID: 33007136 BACKGROUND

MeSH Terms

Conditions

Gallbladder Diseases; Pancreatic Diseases; Choledocholithiasis; Biliary Tract Neoplasms; Pancreatic Neoplasms

Interventions

Duodenoscopes

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Bile Duct Diseases; Cholelithiasis; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endoscopes, Gastrointestinal; Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Results Point of Contact

• Title: Subhas Banerjee, MD
• Organization: Stanford University

subhas.banerjee@stanford.edu

(650) 736-5555

Study Officials

• Subhas Banerjee, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: October 25, 2022
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)