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

Trial ID or NCT#

NCT05429203

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Patients undergoing ERCP for biliary and pancreatic conditions* Age \> 18 years old
Exclusion Criteria:
  1. * 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
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Investigator(s)

Subhas Banerjee
Subhas Banerjee
Gastroenterologist, Therapeutic endoscopy specialist, Biliary specialist, Endoscopic ultrasound specialist
Professor of Medicine (Gastroenterology and Hepatology)

View on ClinicalTrials.gov