1,721,125 research outputs found

    Predictive models in EUS/ERCP

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    : Predictive models (PMs) in endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) have the potential to improve patient outcomes, enhance diagnostic accuracy, and guide therapeutic interventions. This review aims to summarize the current state of predictive models in ERCP and EUS and their clinical implications. To be considered useful in clinical practice a PM should be accurate, easy to perform, and may consider objective variables. PMs in ERCP estimate correct indication, probability of success, and the risk of developing adverse events. These models incorporate patient-related factors and technical aspects of the procedure. In the field of EUS, these models utilize clinical and imaging data to predict the likelihood of malignancy, presence of specific lesions, or risk of complications related to therapeutic interventions. Further research, validation, and refinement are necessary to maximize the utility and impact of these models in routine clinical practice

    Adverse Events of the Single Operator Cholangioscopy System: A MAUDE Database Analysis

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    Background and aims: SpyGlass single operator cholangioscopy (SOC) system is generally considered safe but adds additional risks to those associated with standard endoscopic retrograde cholangiopancreatography. Methods: We evaluated adverse events (AEs) with the SpyGlass System reported in the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2016 & August 2023. Results: A total of 2331 device problems (SpyGlass DS:1301, SpyGlass DS II:1010) were reported. An optical problem was the most reported issue with 83 for the SpyGlass DS and 457 for the SpyGlass DS II. Patient related events were found in 62 (3.5%) of 1743 reports: 33 with SpyGlass DS, and 29 with SpyGlass DSII. The most common AEs were bleeding/hemorrhage followed by perforation, infection, fever, or sepsis and pancreatitis. Conclusions: Our findings add to the existing literature and provides a fuller picture of potential problems associated with SpyGlassTM SOC

    Analysis of Reported Adverse Events Related to Single Use Duodenoscopes and Duodenoscopes with Detachable Endcaps

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    Background: Single use duodenoscopes and duodenoscopes with disposable/detachable caps emerged in the market to mitigate endoscopic retrograde cholangiopancreatography- related risk of infections. We aim to investigate post Food and Drug Administration (FDA) approval adverse events associated with these devices. Methods: We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from July 2018 to June 2021. Results: One hundred and ninety-five reports comprised 206 device issues and 118 patient complications were identified from July 2018 through June 2021. Most device issues related to the single use duodenoscope were due to optical problems (7 reports). Other reported device issues included difficulty in advancing the scope (2 reports), fluid leak (2 reports), and use of device problems (2 reports). Among the duodenoscopes with detachable endcaps, most device issues related to bacterial contamination (52 reports), followed by issues with device use (31 reports), detachment /separation of the device (25 reports), and crack/dent in device material (16 reports). Overall, the most reported patient adverse events were tissue injury (63 reports), perforation (8 reports), and bleeding (7 reports). Ninety reports of microbial contamination of duodenoscopes were identified of which Pseudomonas Aeruginosa was most common. Conclusion: Findings from the MAUDE database highlight patient and device complications that endoscopists should be aware of in using single-use duodenoscopes and duodenoscopes with detachable caps. While these devices mitigate infection transmission risk, they are associated with additional device-associated adverse events
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