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

Not Applicable

Completed

• Conditions: Biliary Disease; Biliary Obstruction; Pancreatic Disease; Choledocholithiasis; Biliary Tract Neoplasms; Pancreatic Neoplasms

• Registration Number: NCT05429203
• Lead Sponsor: Stanford University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Study Start: 2022-10-25
• Primary Completion: 2024-07-29
• Study Completion: 2024-07-29
• Results First Submitted: 2025-07-15
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Results First Posted: 2025-09-15
• Last Update Posted: 2025-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Procedure-related Adverse Events	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 Outcome Measures

Name	Time	Method
Duodenoscope Maneuverability: Intubation Into Esophagus	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.
Duodenoscope Maneuverability: Passage Into Stomach	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.
Duodenoscope Maneuverability: Navigation Across Pylorus	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.
Duodenoscope Maneuverability: Achieving Short Position of the Scope	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.
Duodenoscope Imaging Characteristics Profile: Image Quality	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.
Duodenoscope Maneuverability: Achieving Optimal Papillary Position	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.
Duodenoscope Mechanical Characteristics Profile: Scope Stiffness	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.
Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality	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.
Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency	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.
Duodenoscope Mechanical Characteristics Profile: Hand Strain	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.
Duodenoscope Imaging Characteristics Profile: Image Stability	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.
Number of Participant With Procure Success (Ability to Perform Interventions)	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.

Trial Locations

Locations (1)

Stanford hospital; 🇺🇸 Palo Alto, California, United States