Infection Control in ERCP Using a Duodenoscope With a Disposable Cap

Summary

1. Background \& Rationale

Over 650,000 endoscopic retrograde cholangio-pancreatography (ERCP) procedures are performed annually in the United States alone. ERCP is universally performed using a highly specialized type of flexible endoscope called a duodenoscope. Though critical for the successful completion of ERCP, the design of duodenoscopes makes them among the most complicated medical devices that require routine disinfection and reprocessing. In recent years, several ERCP-related infectious outbreaks have occurred.

Thus, it is clear that novel strategies need to be developed in order to prevent future ERCP-related outbreaks. Specialized duodenoscopes with disposable caps have been developed, and these represent a promising new modality with the potential to drastically reduce the rates of duodenoscope-related infection.
2. Research Questions \& Objectives

There are two co-primary outcomes in this study; the first is to determine the clinical efficacy of a novel duodenoscope with a disposable elevator cap (DEC) system compared with a duodenoscope with a traditional design. The second co-primary objective is to determine the rate of persistent pathogenic contamination of the novel duodenoscope following standardized disinfection and reprocessing protocols compared with a traditional duodenoscope.
3. Methods

This is a prospective, consecutive, randomized controlled study. The intervention arm will comprise use of the ED34-i10T2 duodenoscope with DEC, along with any required standard ERCP accessories, whereas the control arm will comprise use of the ED34-i10T duodenoscope with any required ERCP accessories. All procedures will be performed by expert endoscopists with adequate training, or by advanced endoscopy trainees under direct supervision.

Collected data will include primary endpoints listed above, in addition to patient demographics, endoscopist and trainee data, sedation used, procedural details, and peri-procedural data. Data will be collected at index procedure and at 30-day follow-up. All data will be recorded on REDCap.

Conditions

• Bile Duct Diseases

Interventions

DEVICE

ERCP procedure with Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)

ERCP procedure using Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC) and any necessary accessories.

DEVICE

ERCP procedure with Pentax ED-34i10T Duodenoscope

ERCP procedure using Pentax ED-34i10T Duodenoscope with any necessary accessories.

Sponsors & Collaborators

• Medical University of South Carolina

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Nauzer Forbes, MD MSc · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-03

Primary Completion

2022-02-28

Completion

2022-03-31

Countries

• Canada

Study Locations