Single-Use vs Reusable Duodenoscopes for Biliary and Pancreatic Diseases
Trial Summary
What is the purpose of this trial?
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.
Research Team
Subhas Banerjee, MD
Principal Investigator
Stanford University
Eligibility Criteria
This trial is for adults over 18 who need an ERCP, a special procedure for issues with bile or pancreatic ducts. It's not for pregnant women, those unable to consent, patients with certain infections like CRE or MDRO, or those with complex surgical alterations of the digestive system.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either a duodenoscope with a single-use distal cover or a conventional reusable duodenoscope
Follow-up
Participants are monitored for adverse events and procedure success at 1 week, 1 month, and 3 months after the procedure
Treatment Details
Interventions
- Conventional duodenoscope
- Duodenoscope with single-use distal cover
- Endoscopic retrograde cholangiopancreatography (ERCP)
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Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor