Status:

COMPLETED

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

Lead Sponsor:

Stanford University

Conditions:

Biliary Disease

Pancreatic Disease

Eligibility:

All Genders

18+ years

Phase:

NA

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 cur...

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 cholangiopancreat...

Eligibility Criteria

Inclusion

  • Patients undergoing ERCP for biliary and pancreatic conditions
  • Age \> 18 years old

Exclusion

  • 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

Key Trial Info

Start Date :

October 25 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 29 2024

Estimated Enrollment :

319 Patients enrolled

Trial Details

Trial ID

NCT05429203

Start Date

October 25 2022

End Date

July 29 2024

Last Update

September 15 2025

Active Locations (1)

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1

Stanford hospital

Palo Alto, California, United States, 943305