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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of tools used in a procedure called ERCP (endoscopic retrograde cholangiopancreatography), which treats issues in the bile ducts and pancreas. One tool is a regular duodenoscope, while the other has a disposable part. The goal is to determine which tool performs better and causes fewer complications for patients. Individuals requiring an ERCP for bile or pancreatic issues may be suitable candidates for this study. As an unphased trial, this study provides an opportunity to contribute to advancements in ERCP procedures.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these duodenoscopes are safe for ERCP procedures?

Research has shown that single-use duodenoscopes are very safe, designed to reduce infection risks associated with reusable scopes. One study found that single-use scopes performed well and caused few side effects during various procedures.

For reusable duodenoscopes, earlier studies found contamination rates of 3.6% and 5.4% for different bacteria types. This indicates they are generally safe but may pose a higher infection risk than single-use ones.

Overall, both types of duodenoscopes are considered safe, but single-use versions may better prevent infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares single-use and reusable duodenoscopes for treating biliary and pancreatic diseases. Currently, conventional duodenoscopes are standard, but they can be challenging to clean, risking cross-contamination. The introduction of a single-use distal cover aims to enhance safety by reducing infection risks associated with reusable scopes. This innovation could lead to safer procedures and better patient outcomes, making it a promising development in endoscopic treatments.

What evidence suggests that these duodenoscopes are effective for biliary and pancreatic diseases?

This trial will compare a conventional duodenoscope with one that has a single-use distal cover for procedures like ERCP, which helps doctors examine the bile and pancreatic ducts. Research has shown that duodenoscopes with a single-use tip provide reliable and safe results. Studies have found that these single-use scopes perform well in various procedures and maintain a good safety record. Patients and doctors reported high satisfaction, with an average score of 8 out of 10. Additionally, these scopes may reduce the risk of infections associated with reusable scopes. Overall, evidence suggests that this type of duodenoscope is effective and could be a safer choice compared to traditional reusable ones. ^{1 4 5 6 7}

Who Is on the Research Team?

Subhas Banerjee, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05429203

NCT05429203 | Comparison of Duodenoscope With ... The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10684334/

Global prospective case series of ERCPs using a single- ... Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]).

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949708622000140

Performance of single-use duodenoscopes for ERCP Our analysis showed that SUDs deliver consistent performance across a wide range of ERCP procedures with an excellent safety profile.

4. cghjournal.org cghjournal.org/article/S1542-3565(19)31261-3/fulltext

Clinical Evaluation of a Single-Use Duodenoscope for ... Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, ...

5. trialx.com trialx.com/clinical-trials/listings/253128/comparison-of-duodenoscope-with-single-use-distal-cover-and-the-conventional-reusable-duodenoscope/?&radius=50

Comparison of Duodenoscope With Single-use Distal ... Overview. The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8040157/

Equivalent performance of single-use and reusable ... Single-use duodenoscopes have been recently developed to eliminate risk of infection transmission from contaminated reusable duodenoscopes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9666816/

Single-Use Duodenoscopes for ERCP In 2019, preliminary results revealed duodenoscope contamination rates of 3.6% and 5.4% for low to moderate and high concern organisms, respectively, despite ...