Efficacy and safety of a novel device (OptimosTM Dilatation Device) in endoscopic retrograde cholangiopancreatography (ERCP) for removal of biliary stones: a pilot study

Chonnam National University Hospital0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年6月24日

试验速览

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•Patients with all of the following:
•1) Diagnosis of choledocholithiasis using abdominal imaging studies (e.g., CT, MRI, or endoscopic ultrasonography) or laboratory tests
•2) Those who will follow the treatment methods and visit for follow-ups
•3) Those who understand and agree to participate in this study

•Patients with any of the following:
•1) Those who cannot give informed consent and agree to participate in this study
•2) Those under the age of 20
•3) Those over the age of 90
•4) Those with previous history of bile duct stone removal by ERCP
•5) Those with bleeding tendency/coagulopathy or platelet count <50,000/mm3 or INR >1.5
•6) Those taking antiplatelet agents (e.g.,clopidogrel, prasugrel, ticagrelor) and who have not stopped these medications for more than 5 days
•7) Those taking anticoagulants (e.g., dabigatran, ribaroxaban, apixaban, edoxaban) and who have not stopped these medications for more than 48 hours
•8) Those taking warfarin and who have not stopped this medication for more than 5 days or has INR > 1.5
•9) Pregnant women
•10) Those who are unable to undergo this procedure at the endoscopist's disrcetion

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