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

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

Recruiting
18 years and older
All
Phase N/A

Overview

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.

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

Print
Study details
    Biliary Disease
    Pancreatic Disease
    Choledocholithiasis
    Biliary Obstruction
    Biliary Tract Neoplasms
    Pancreatic Neoplasms

NCT05429203

Stanford University

13 December 2024

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