Comparing two types of duodenoscopes for ERCP procedures
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
NA · Stanford University · NCT05429203
This study is testing whether a single-use duodenoscope is safer and more effective than a regular reusable one for patients undergoing ERCP procedures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05429203 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness and safety of two types of duodenoscopes used during Endoscopic retrograde cholangiopancreatography (ERCP) procedures: one with a single-use distal cover and a conventional reusable version. Patients eligible for the study will be randomly assigned to receive one of the two duodenoscopes during their ERCP. The study will monitor procedure success rates and complication rates, with follow-up assessments conducted at one week, one month, and three months post-procedure to gather data on any adverse events. The goal is to determine if the single-use duodenoscope offers any advantages over the conventional type.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are undergoing ERCP for biliary or pancreatic conditions.
Not a fit: Patients who are pregnant, unable to consent, or have specific infections or surgically altered anatomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and effectiveness in ERCP procedures for patients with biliary and pancreatic diseases.
How similar studies have performed: Other studies have explored the use of single-use endoscopes, showing promising results, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California
- Stanford hospital — Palo Alto, California, United States (RECRUITING)
Study contacts
- Principal investigator: Subhas Banerjee, MD — Stanford University
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Biliary Disease, Pancreatic Disease, Choledocholithiasis, Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Neoplasms, ERCP, Duodenoscope