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

• Sponsor: Stanford University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05429203
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 20.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Disease; Pancreatic Disease; Choledocholithiasis; Biliary Obstruction; Biliary Tract Neoplasms; Pancreatic Neoplasms	Device: Duodenoscope with single-use distal cover; Device: Conventional duodenoscope	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• 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
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Aug 30, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Duodenoscope with single-use distal cover Patients will undergo ERCP using a duodenoscope with a single-use distal cover	Device: Duodenoscope with single-use distal cover; Newer duodenoscope with a single-use distal cover
Active Comparator: Conventional Duodenoscope Patients will undergo ERCP using a conventional duodenoscope	Device: Conventional duodenoscope; Conventional duodenoscope with standard methods of reprocessing

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford hospital	Palo Alto	California	United States	943305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Subhas Banerjee, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bang JY, Rösch 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.

• Responsible Party: Subhas Banerjee, Professor of Medicine, Stanford University
• ClinicalTrials.gov Identifier: NCT05429203
• Other Study ID Numbers: 65189
• First Posted: Jun 23, 2022
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Subhas Banerjee, Professor of Medicine, Stanford University: ERCP; Duodenoscope; Duodenoscope with single-use distal cover
• Additional relevant MeSH terms: Neoplasms; Pancreatic Neoplasms; Biliary Tract Neoplasms; Choledocholithiasis; Pancreatic Diseases; Gallbladder Diseases

Study Results

No Results Posted as of Jun 23, 2022