Efficacy of Single Use Disposable Elevator Cap (DEC) Duodenoscopy

NCT ID: NCT05800171

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2025-02-21

Brief 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.

Detailed 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.

Conditions

Cholangitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myeong Hwan Lee, M.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Myeong Hwan Lee, MD

Role: CONTACT

dlaudghks01@naver.com

82-2-7733-6494

Facility Contacts

Woo Hyun Paik, MD, PhD

Role: primary

iatrus@hanmail.net

82-2-2072-2228

Jin Ho Choi, MD

Role: backup

pseudo.jh@gmail.com

82-2-2072-2228

Other Identifiers

2301-097-1396

Identifier Type: -

Identifier Source: org_study_id