NCT05800171

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

April 24, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2025

Completed
Last Updated

July 3, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

March 23, 2023

Last Update Submit

June 29, 2023

Conditions

Cholangitis

Keywords

Single use disposable elevator cap duodenoscopeCholangitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of cholangitis cuased by MDR pathogens

    percentage

    complication with in 2weeks after ERCP

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care clinic

You may qualify if:

  • Patient who undergone ERCP
  • years age or older

You may not qualify if:

  • Patients who already undergone biliary drainage
  • Patient who already confirmed of multidrug resistant bacterial infection
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Cholangitis

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Myeong Hwan Lee, M.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myeong Hwan Lee, MD

CONTACT

82-2-7733-6494dlaudghks01@naver.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 5, 2023

Study Start

April 24, 2023

Primary Completion

February 21, 2024

Study Completion

February 21, 2025

Last Updated

July 3, 2023

Record last verified: 2023-02

Locations

KR(1)