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

Pancreatic Neoplasms Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429203
• Other study ID #: 65189
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Disease
• Biliary Obstruction
• Biliary Tract Neoplasms
• Choledocholithiasis
• Gallbladder Diseases
• Neoplasms
• Pancreatic Disease
• Pancreatic Diseases
• Pancreatic Neoplasms

Intervention

Device:
• Duodenoscope with single-use distal cover
Newer duodenoscope with a single-use distal cover
• Conventional duodenoscope
Conventional duodenoscope with standard methods of reprocessing

Locations

Country	Name	City	State
United States	Stanford hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with procedure-related adverse events	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.	3 months
Secondary	Duodenoscope maneuverability	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).	Maneuverability will be assessed only during the procedure (approximately 10 minutes)
Secondary	Duodenoscope mechanical characteristics profile	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.	Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)
Secondary	Duodenoscope imaging characteristics profile	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.	Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)
Secondary	Ability to perform interventions	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.	30-60 minutes