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

Not Applicable

Recruiting

• 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
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 will be 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 imaging characteristics profile	Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)	Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their imaging characteristics (image quality and stability). Each characteristic will be assessed using a published 5-point scoring system.
Duodenoscope mechanical characteristics profile	Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)	Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their mechanical characteristics (scope stiffness, air-water button functionality, elevator efficiency and hand strain). Each characteristic will be assessed using a published 5-point scoring system.
Duodenoscope maneuverability	Maneuverability will be assessed only during the procedure (approximately 10 minutes)	Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for its maneuverability during the procedure 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(1).
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. Each patient's procedure will be assessed on 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.

Trial Locations

Locations (1)

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