Efficacy of Single Use Disposable Elevator Cap (DEC) Duodenoscopy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cholangitis

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Myeong Hwan Lee, MD; Phone Number: 82-2-7733-6494; Email: dlaudghks01@naver.com

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 110-744
      • Recruiting
      • Seoul National University Hospital
      • Contact: Jin Ho Choi, MD; Phone Number: 82-2-2072-2228; Email: pseudo.jh@gmail.com
      • Contact: Woo Hyun Paik, MD, PhD; Phone Number: 82-2-2072-2228; Email: iatrus@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

primary care clinic

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cholangitis cuased by MDR pathogens	percentage	complication with in 2weeks after ERCP

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Myeong Hwan Lee, M.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Estimated): February 21, 2024
• Study Completion (Estimated): February 21, 2025

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cholangitis; Single use disposable elevator cap duodenoscope
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholangitis
• Other Study ID Numbers: 2301-097-1396

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No