Optimizing Short-term Antibiotic Treatment in Acute Cholangitis: rationale and study protocol for an open-label randomized controlled trial - The BOLT-P3 Trial (Biliary Optimal Limited Treatment - Phase 3) (Biliary Optimal Limited Treatment - Phase 3 (BOLT-B3 ))

未提供0 个研究点目标入组 210 人开始时间: 2024年6月5日最近更新: 2024年11月20日

试验速览

阶段: 不适用
状态: 招募中
入组人数: 210
主要终点: clinical cure rate

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•Participants must meet all of the following criteria:
•Disease: Patients diagnosed with AC in accordance with the TG18, regardless of benign or malignant nature. However, for patients with AC due to dysfunction of distal bile duct stents, inclusion is limited to those who have had a stent in place for more than 30 days.
•Age: 18 years or older.
•Previous Treatment: Cases where biliary obstruction has been technically successfully relieved through biliary drainage procedures with ERCP within 48 hours of hospitalization.
•Consent: Written consent obtained from the patient or their legal representative for participation in this trial.

排除标准

•Participants will be excluded if they meet any of the following criteria:
•Circulatory insufficiency with catecholamines at the time of ERCP.
•Requirement for intensive care unit ICU admission.
•Hypothermia below 35 degrees Celsius.
•Recurrent cholangitis within 3 months.
•Malignant or benign biliary stricture equivalent to or beyond Bismuth 2 type in the hepatic portal area, or indeterminate cause of biliary obstruction.
•Patients with anatomical changes due to surgery such as biliary-jejunal anastomosis excluding Billroth I.
•Concomitant pancreatitis based on International Pancreatic Society/American Pancreatic Association guidelines, meeting two of the following criteria: Upper abdominal pain, Serum amylase or lipase more than three times upper limit of normal ULN, Imaging signs of acute pancreatitis.
•Concurrent cholecystitis according to TG18 criteria, meeting one item from A and one from B and C:
•A. Local signs of inflammation: Murphy's sign, or right upper quadrant mass, pain, or tenderness.
•B. Systemic signs of inflammation: fever with axillary temperature more than 37.1C, elevated C-reactive protein CRP more than 3.0 mg/dL, or elevated white blood cell WBC count more than 10,000 uL.
•C. Imaging findings characteristic of acute cholecystitis.
•Concurrent hepatic abscess.
•Concurrent other infections.
•Patients receiving continuous administration of antibiotics prior to registration.
•Complications from ERCP prior to registration such as perforation, pancreatitis, bleeding, cholecystitis, cardiopulmonary diseases due to sedation; aspiration pneumonia, choking, cardiac arrest, etc.
•Specific immunosuppressed states:
•A. Use of immunosuppressants including prednisolone more than 10 mg.
•B. Known human immune virus infection.
•C. Neutropenia within 48 hours prior to randomization, neutrophils less than or equal to 1500 uL.
•D. Autologous hematopoietic stem cell transplantation within 1 month and at any point prior to engraftment in allogeneic hematopoietic stem cell transplantation.
•Pregnant women.
•Other cases deemed unsuitable for the trial by the attending physician.

结局指标

主要结局

clinical cure rate

时间窗: 14 days

The rate of cases that achieve clinical cure within 14 days and survive without recurrence.

次要结局

未报告次要终点

研究者

发起方

未提供

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