Single-Use vs Reusable Duodenoscopes for Biliary and Pancreatic Diseases

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, Inability to consent, Cholangitis, CRE, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

600 Participants Needed

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

I am older than 18 years.

I am having an ERCP for a bile duct or pancreatic condition.

Exclusion Criteria

I have had surgery that changed my body's structure, but not a Billroth I procedure.

Pregnant women are not allowed to participate in the study.

I have been diagnosed with cholangitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either a duodenoscope with a single-use distal cover or a conventional reusable duodenoscope

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and procedure success at 1 week, 1 month, and 3 months after the procedure

3 months

3 follow-up calls

Treatment Details

Interventions

• Conventional duodenoscope
• Duodenoscope with single-use distal cover
• Endoscopic retrograde cholangiopancreatography (ERCP)

Trial Overview The study compares two tools used in ERCP: one is a duodenoscope with a single-use cover and the other is the standard reusable version. The goal is to see which one has better success rates and fewer complications.

Participant Groups

Group I: Conventional Duodenoscope Active Control 1 Intervention

Patients will undergo ERCP using a conventional duodenoscope

Group II: Duodenoscope with single-use distal cover Active Control 1 Intervention

Patients will undergo ERCP using a duodenoscope with a single-use distal cover

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+