An observational study in Cholangitis, sponsored by Seoul National University Hospital. Status unknown at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Seoul National University Hospital · Observational
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:
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.
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.
226 studies on the registry are indexed under Cholangitis; 31 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 137 across 64 observational studies indexed under Cholangitis.
Browse Cholangitis studies →Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Incidence of cholangitis cuased by MDR pathogens
percentage
Time frame: complication with in 2weeks after ERCP
Started Apr 2023 (actual). Primary completion is estimated for Feb 2024, 9 months after the start.
Of 30 observational studies under Cholangitis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 60. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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