Short-Term Prophylactic Biliary Stenting After Complete Common Bile Duct Stone Removal for Prevention of Post-ERCP Cholangitis: A Multicenter Randomized Controlled Trial (Short-Term Prophylactic Biliary Stenting After Complete Common Bile Duct Stone Removal for Prevention of Post-ERCP Cholangitis: A Multicenter Randomized Controlled Trial (STEP-ERCP))

未提供0 个研究点目标入组 186 人开始时间: 待定

试验速览

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•Patients aged 20 years or older at registration.
•Patients diagnosed with common bile duct stones by imaging studies and scheduled to undergo ERCP.
•Patients who do not meet the suspected or definite diagnosis of acute cholangitis based on Tokyo Guidelines 2018 immediately before ERCP.
•Patients whose hepatobiliary enzymes are within three times the upper limit of normal at each institution.
•Patients with body temperature less than 38.0 degrees C, white blood cell count 4000 to 10000/uL, and CRP less than 1.0 mg/dL immediately before ERCP.
•Patients who have provided written informed consent after receiving sufficient explanation of the study.

•Patients diagnosed with suspected or definite acute cholangitis based on Tokyo Guidelines 2018 at the time of ERCP or within 2 weeks before ERCP
•Patients in whom standard ERCP is difficult or non-standard, including malignant biliary stricture, ampullary tumor, or surgically altered anatomy other than Billroth I reconstruction
•Patients with serious safety concerns, such as biliary perforation, severe infection, or markedly poor general condition
•Patients with severe cardiopulmonary disease or renal failure who cannot tolerate endoscopic treatment under general anesthesia or sedation
•Patients judged by the investigator or sub-investigator to be inappropriate for study participation for medical reasons

发起方

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