Clinical trial NCT05429203: Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Biliary Disease
Pancreatic Disease
Choledocholithiasis
Biliary Obstruction
Biliary Tract Neoplasms
Pancreatic Neoplasms
Keywords: ERCP
Duodenoscope
Duodenoscope with single-use distal cover
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with procedure-related adverse events
timeFrame: 3 months
Secondary outcomes:
measure: Duodenoscope maneuverability
timeFrame: Maneuverability will be assessed only during the procedure (approximately 10 minutes)
measure: Duodenoscope mechanical characteristics profile
timeFrame: Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)
measure: Duodenoscope imaging characteristics profile
timeFrame: Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes)
measure: Ability to perform interventions
timeFrame: 30-60 minutes
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford hospital
state: California
Study officials:
affiliation: Stanford University
name: Subhas Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.