Skip to main content
OpenTrials
Completed

NCT Number: NCT05429203

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Biliary Disease Bile Duct Diseases Biliary Obstruction Biliary Tract Diseases Biliary Tract Neoplasms Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gallbladder Diseases Neoplasms Neoplasms by Site Pancreatic Disease Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford hospital

Palo Alto, California, 943305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duodenoscope with single-use distal cover

Device

Newer duodenoscope with a single-use distal cover

Conventional duodenoscope

Device

Conventional duodenoscope with standard methods of reprocessing

Primary outcomes

  1. 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.

Secondary outcomes

  1. Duodenoscope Maneuverability: Intubation Into Esophagus

    Time frame: 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.

  2. Duodenoscope Maneuverability: Passage Into Stomach

    Time frame: 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.

  3. Duodenoscope Maneuverability: Navigation Across Pylorus

    Time frame: 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.

  4. Duodenoscope Maneuverability: Achieving Short Position of the Scope

    Time frame: 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.

  5. Duodenoscope Maneuverability: Achieving Optimal Papillary Position

    Time frame: 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.

  6. Duodenoscope Mechanical Characteristics Profile: Scope Stiffness

    Time frame: 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.

  7. Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality

    Time frame: 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.

  8. Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency

    Time frame: 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.

  9. Duodenoscope Mechanical Characteristics Profile: Hand Strain

    Time frame: 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.

  10. Duodenoscope Imaging Characteristics Profile: Image Quality

    Time frame: 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.

  11. Duodenoscope Imaging Characteristics Profile: Image Stability

    Time frame: 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.

  12. Number of Participant With Procure Success (Ability to Perform Interventions)

    Time frame: 30-60 minutes

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2022
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.