Skip to main content
OpenTrials
Completed

NCT Number: NCT04143698

Reusable Versus Disposable Duodenoscopes for ERCP

The aim of this randomized trial is to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the disposable (single-use) and reusable duodenoscopes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endoscopic Retrograde Cholangiopancreatography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AdventHealth Orlando

Orlando, Florida, 32803, United States

About this study

Given the recent reports on infection outbreaks, including carbapenem-resistant Enterobacteriaceae (CRE), caused by contaminated duodenoscopes used at endoscopic retrograde cholangiopancreatography (ERCP), a disposable (single-use) duodenoscope (Exalt, Single-Use Duodenoscope, Boston Scientific Corporation, Natick, MA) has been developed to circumvent this issue. However, there are currently no data on the technical features and outcomes of disposable duodenoscopes, in comparison with reusable duodenoscopes.

The aim of this randomized trial is therefore to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the two duodenoscope types.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Patients with native papilla
  • Requiring an ERCP procedure for biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at computed tomography or magnetic resonance cholangiopancreatography

Exclusion criteria

  • Age <18 years old
  • Unable to obtain informed consent
  • Pregnancy
  • Altered upper gastrointestinal surgical anatomy
  • Patients with percutaneous transhepatic biliary drainage catheters
  • Prior history of ERCP

Treatment and study plan

endoscopic retrograde cholangiopancreatography

Device

The duodenoscope will be passed to the duodenum in the standard fashion. Once the papilla has been identified in the duodenum, cannulation of the desired duct will be performed in the standard fashion, with the type of accessories used left to the discretion of the individual endoscopist performing the procedure. If cannulation is considered difficult, advanced cannulation techniques can be used per standard of care at the discretion of the individual endoscopist. The types of accessories used will be left to the discretion of the individual endoscopist and will be dependent on procedure indication and personal preference. Cross-over to the alternate duodenoscope type can be performed at any time if the desired technical maneuver cannot be performed with the designated duodenoscope.

Other names: ERCP

Primary outcomes

  1. Cannulation

    Time frame: 1 day

    The ease of cannulation of the desired duct (biliary or pancreatic), as measured by the total number of cannulation attempts to achieve successful cannulation of the desired duct.

Secondary outcomes

  1. Ease of passage of duodenoscope and imaging and mechanical function of the duodenoscope

    Time frame: 1 day

    Ease of maneuverability of the duodenoscope to reach the major papilla, the imaging and mechanical function of the duodenoscope, measured on a five point scale with 1 being the easiest and 5 being the most difficult.

  2. Ease of completion of interventions

    Time frame: 1 day

    Ease of completion of each step of the ERCP procedure, measured on a 5 point scale with 1 being the easiest and 5 being the most difficult.

  3. Rate of use of advanced cannulation techniques

    Time frame: 1 day

    Need for use of advanced cannulation techniques

  4. Rate of cross-over

    Time frame: 1 day

    Rate of cross-over to the alternate duodenoscope for completion of the procedure

  5. Time taken for cannulation

    Time frame: 1 day

    Time taken for cannulation

  6. Total duration of the procedure

    Time frame: 1 day

    Total duration of the procedure

  7. Rate of adverse events

    Time frame: 7 days and 30 days

    Assessment of AEs and SAEs

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

Randomized Trial Comparing Reusable and Disposable Duodenoscopes for ERCP

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2019
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.