Infection Control in ERCP Using a Duodenoscope With a Disposable Cap (ICECAP)
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|ClinicalTrials.gov Identifier: NCT04040504|
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : January 2, 2020
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Bile Duct Diseases||Device: ERCP procedure with Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC) Device: ERCP procedure with Pentax ED-34i10T Duodenoscope||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||520 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||The patient, investigator and outcomes assessors will be blinded to the intervention. The endoscopist will not be blinded, since the type of scope and cap being used can be detected during the procedure.|
|Official Title:||Clinical Efficacy and Infection Risk of ERCP Using a Novel Duodenoscope With a Disposable Cap: a Randomized Controlled Trial|
|Actual Study Start Date :||December 3, 2019|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
Experimental: Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)
Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)
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.
Active Comparator: Pentax ED-34i10T Duodenoscope
Pentax ED-34i10T Duodenoscope
Device: ERCP procedure with Pentax ED-34i10T Duodenoscope
ERCP procedure using Pentax ED-34i10T Duodenoscope with any necessary accessories.
- ERCP technical success rate [ Time Frame: Immediate ]Technical success will be determined in duplicate by two blinded outcome adjudicators with no knowledge of the patient's allocation in the study. The adjudicators will review redacted and de-identified procedure reports for each study patient, and determine the presence or absence of technical success of the overall procedure based on a set of a priori definitions.
- Persistent bacterial contamination rate [ Time Frame: Immediate ]Persistent bacterial contamination will be assessed following standardized disinfection and reprocessing using microbiologic swabs and culturing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040504
|Contact: Nauzer Forbes, MD MScfirstname.lastname@example.org|
|Contact: Millie Chau, BSvcemail@example.com|
|Peter Lougheed Centre||Recruiting|
|Contact: Nauzer Forbes|
|Principal Investigator:||Nauzer Forbes, MD MSc||University of Calgary|