Efficacy of Single Use Disposable Elevator Cap (DEC) Duodenoscopy

Cholangitis Clinical Trial

Official title:

A Prospective Cohort Study on the Efficacy of Single Use Disposable Elevator Cap (DEC) Duodenoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800171
• Other study ID #: 2301-097-1396
• Status: Recruiting
• Start date: April 24, 2023
• Est. completion date: February 21, 2025

Study information

• Verified date: February 2023
• Source: Seoul National University Hospital
• Contact: Myeong Hwan Lee, MD
• Phone: 82-2-7733-6494
• Email: dlaudghks01[@]naver.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this prospective cohort observational study is to compare incidence of cholangitis cause by multi-drug resistant pathogens in patient who underwent ERCP.

The main question it aims to answer are:

• Is the single use disposable elevator cap duodenoscope more effective in preventing cholangitis caused by MDR than fixed cap duodeoscope?

• Is the single use disposable elevator cap duodenoscope more effective in preventing severe cholangitis than fixed cap duodenoscope?

Participants will undergo and ERCP procedure. Among the patients who received the procedure, those who developed cholangitis after procedure will treated with antibiotics after blood culture test. The result of the post procedure cholangitis group's blood culture test and lab data including LFT will be collected. Researches will compare single use disposable elevator cap duodenoscope group and fixed distal cap duodenoscope group to see if there is difference in the incidence of cholangitis caused by MDR pathogens.

Description:

Insufficient disinfection of duodenoscopes, particularly the elevator site, can cause ERCP-related infections and serve as a significant source of multidrug-resistant (MDR) infection. To address this issue, a disposable elevator cap (DEC) was developed, and a recent randomized clinical trial demonstrated its effectiveness in reducing contamination following high-level disinfection. However, there is limited evidence in actual clinical practice to reduce cholangitis caused by MDR pathogens. This study aimed to compare the efficacy of the novel DEC duodenoscope with the standard duodenoscope in preventing infection transmission.

We conducted a prospective non-randomized cohort study in a single institution comparing baseline characteristics, technical performance, and incidence of acute cholangitis, including MDR pathogen, in 95 patients using a standard duodenoscope and 101 patients using a DEC duodenoscope.

Age, sex, comorbidities, and indication for ERCP were similar between the two groups. However, the standard duodenoscope group had a higher proportion of naïve papilla (51% vs. 34%, p = 0.04), while the technical success rate was slightly higher in the DEC duodenoscope group (95% vs. 85%, p = 0.15). The rates of procedure-related adverse events were similar between the two groups (16% for DEC vs. 15% for standard). The incidence of post-ERCP cholangitis was also similar (10% for DEC vs. 11% for standard, p = 0.90). The proportion of post-ERCP cholangitis caused by MDR pathogens was similar in the two groups (1% for DEC vs. 2% for standard, p = 0.39).

This study suggests that the technical performance of the DEC duodenoscope is similar to that of the standard duodenoscope. However, more clinical data are needed to confirm the efficacy of the DEC duodenoscope in preventing ERCP-related infection transmission.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: February 21, 2025
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patient who undergone ERCP

• 19 years age or older

Exclusion Criteria:

• Patients who already undergone biliary drainage

• Patient who already confirmed of multidrug resistant bacterial infection

• Pregnant women

Related Conditions & MeSH terms

• Cholangitis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cholangitis cuased by MDR pathogens	percentage	complication with in 2weeks after ERCP