Masuda Sakue, Imamura Yoshinori, Kimura Karen, Makazu Makomo, Kubota Jun, Takihara Hiroshi, Jinushi Ryuhei, Fujikawa Tomoaki, Maejima Kyohei, Kawanishi Aya, Yamamoto Ryuichi, Noda Shogo, Koyama Taiji, Sugitani Ayumu, Ryozawa Shomei, Koizumi Kazuya
Department of Gastroenterology Medicine Center, Shonan Kamakura General Hospital, Kamakura, 247-8533, Japan.
Cancer Care Promotion Center, University of Fukui Hospital, Eiheiji, Fukui, 910-1193, Japan.
Trials. 2025 Sep 1;26(1):324. doi: 10.1186/s13063-025-09077-1.
Acute cholangitis (AC) frequently presents as a community-acquired infection and is associated with a high prevalence of antibiotic use among infectious diseases. The Tokyo Guidelines 2018 (TG18) recommend 4-7 days of antibiotic administration after biliary drainage. However, this recommendation lacks strong evidence of its effectiveness and is primarily based on heterogeneous clinical findings and expert opinions. Recent retrospective studies have advocated a shorter 1- to 3-day antibiotic course as effective for AC treatment, prompting the need to reassess the treatment duration to achieve therapeutic efficacy while minimizing resistance and adverse effects.
We designed a multicenter, non-blinded, randomized trial to evaluate the efficacy of short-course therapy compared to standard-course therapy for AC management. The short-course therapy group will receive 1-3 days of intravenous (IV) antibiotic treatment after successful biliary drainage compared to 4-7 days of IV antibiotics after successful biliary drainage for the standard-course therapy group. The primary outcome is the clinical cure rate within 14 days from the endoscopic retrograde cholangiopancreatography (ERCP) procedure. Participants will be allocated to either treatment course using a minimization method in a non-blinded, randomized manner, with stratification factors including condition severity and facility. We determined that 210 participants would be required to achieve a statistical power of 90% with a one-sided significance threshold of 2.5% and a non-inferiority limit of 10%.
This phase 3 trial aims to determine the non-inferiority of short-course therapy over standard-course therapy. Shortening the duration of antibiotic administration may mitigate the emergence of resistant bacteria, adverse events, and reduce hospital stay length and healthcare costs. https://jrct.niph.go.jp/re/reports/detail/73862 TRIAL REGISTRATION: This study was registered at the Japan Registry of Clinical Trials under registry number jRCT1031230709. Registered on 14 March 2024, https://jrct.niph.go.jp/re/reports/detail/73862.
急性胆管炎（AC）常表现为社区获得性感染，在传染病中抗生素使用率很高。《2018年东京指南》（TG18）建议在胆道引流后使用抗生素4 - 7天。然而，这一建议缺乏其有效性的有力证据，主要基于异质性的临床发现和专家意见。最近的回顾性研究主张采用更短的1至3天抗生素疗程治疗AC有效，这促使有必要重新评估治疗时长，以在最小化耐药性和不良反应的同时实现治疗效果。
我们设计了一项多中心、非盲、随机试验，以评估短疗程治疗与标准疗程治疗在AC管理中的疗效。短疗程治疗组在成功进行胆道引流后将接受1 - 3天的静脉抗生素治疗，而标准疗程治疗组在成功进行胆道引流后接受4 - 7天的静脉抗生素治疗。主要结局是自内镜逆行胰胆管造影（ERCP）操作起14天内的临床治愈率。参与者将采用最小化法以非盲、随机的方式分配至任一治疗疗程，分层因素包括病情严重程度和医疗机构。我们确定需要210名参与者，以达到90%的统计效能，单侧显著性阈值为2.5%，非劣效性界限为10%。
这项3期试验旨在确定短疗程治疗相对于标准疗程治疗的非劣效性。缩短抗生素给药时长可能会减轻耐药菌的出现、不良事件，并减少住院时间和医疗费用。https://jrct.niph.go.jp/re/reports/detail/73862 试验注册：本研究已在日本临床试验注册中心注册，注册号为jRCT1031230709。于2024年3月14日注册，https://jrct.niph.go.jp/re/reports/detail/73862。
