{
  "abstract": "Introduction: Endoscopic retrograde cholangiopancreatography (ERCP) is the standard treatment for common bile duct stones. Although complete stone removal can be achieved in most cases, post-ERCP cholangitis still occurs in a subset of patients, even in the absence of preprocedural cholangitis. Temporary prophylactic biliary stenting after complete stone extraction may reduce post-ERCP cholangitis by preventing transient biliary obstruction caused by papillary oedema, impaired bile drainage or residual biliary sludge. However, evidence supporting this strategy is currently limited to retrospective studies. The STEP-ERCP study is designed to test the hypothesis that short-term prophylactic biliary stenting after complete removal of common bile duct stones reduces the incidence of post-ERCP cholangitis compared with no biliary stenting.\n\nMethods and analysis: The STEP-ERCP study is a multicentre, prospective, open-label, randomised controlled superiority trial. Adult patients undergoing ERCP for common bile duct stones without evidence of acute cholangitis at the time of ERCP and achieving complete stone clearance will be enrolled. Participants will be randomly assigned in a 1:1 ratio to prophylactic biliary stenting using a spontaneous dislodgement biliary stent or no stenting. Randomisation will be stratified by participating institution and maximum stone diameter (<10 mm vs ≥10 mm). The primary endpoint is the incidence of post-ERCP cholangitis within 7 days after ERCP, diagnosed using modified Tokyo Guidelines 2018 criteria adapted for post-ERCP conditions. Secondary endpoints include cholangitis severity, time to cholangitis onset, therapeutic antibiotic use, repeat ERCP or biliary drainage, ERCP-related adverse events and revisit or readmission within 30 days after ERCP. A total of 186 participants will be enrolled.\n\nEthics and dissemination: The study will be conducted in accordance with the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects in Japan.\n\nThe study protocol was approved by the Institutional Review Board of Yokohama City University Hospital on 11 May 2026. Additional approval will be obtained from participating institutions before study initiation.\n\nWritten informed consent will be obtained from all participants.\n\nStudy findings will be disseminated through peer-reviewed publications and scientific conferences.\n\nTrial registration number: jRCT1032260128",
  "abstract_shown": true,
  "affiliations": [
    "Gastroenterology and Hepatology, Yokohama City University Hospital, Yokohama, Japan",
    "Department of Gastroenterology, Sendai City Medical Center, Sendai, Japan",
    "Department of Biostatistics, Yokohama City University, Yokohama, Kanagawa, Japan",
    "Department of Gastroenterology, National Hospital Organization Yokohama Medical, Yokohama, Japan",
    "Department of Gastroenterology, Yokohama Rosai Hospital, Yokohama, Japan",
    "Department of Hepato-Biliary-Pancreatic Medicine, NTT Medical Center Tokyo, Tokyo, Japan",
    "Department of Gastroenterology, Yokosuka General Medical Center, Kanagawa, Japan",
    "Department of Gastroenterology, Chigasaki Municipal Hospital, Kanagawa, Japan",
    "Department of Gastroenterology and Hepatology, International University of Health and Welfare Atami Hospital, Shizuoka, Japan",
    "Department of Palliative Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan",
    "Department of Gastroenterology, Yokohama Sakae Kyosai Hospital, Yokohama, Japan",
    "Department of Gastroenterology, Omori Red Cross Hospital, Tokyo, Japan",
    "Department of Gastroenterology, International University of Health and Welfare Narita Hospital, Chiba, Japan"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 20,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Sho Hasegawa",
      "orcid": "0000-0002-1671-0643"
    },
    {
      "affs": [
        1
      ],
      "name": "Yoshihide Kanno"
    },
    {
      "affs": [
        2
      ],
      "name": "Satoru Shinoda"
    },
    {
      "affs": [
        3
      ],
      "name": "Shinichi Nihei"
    },
    {
      "affs": [
        4
      ],
      "name": "Yusuke Sekino"
    },
    {
      "affs": [
        5
      ],
      "name": "Yuji Fujita"
    },
    {
      "affs": [
        6
      ],
      "name": "Kunihiro Hosono"
    },
    {
      "affs": [
        7
      ],
      "name": "Takamitsu Sato"
    },
    {
      "affs": [
        8
      ],
      "name": "Yasunari Sakamoto"
    },
    {
      "affs": [
        9
      ],
      "name": "Takaomi Kessoku"
    },
    {
      "affs": [
        10
      ],
      "name": "Akito Iwasaki"
    },
    {
      "affs": [
        11
      ],
      "name": "Takuya Takayanagi"
    },
    {
      "affs": [
        12
      ],
      "name": "Tomoki Ogata"
    },
    {
      "affs": [
        0
      ],
      "name": "Yu Honda"
    },
    {
      "affs": [
        0
      ],
      "name": "Takayuki Oda",
      "orcid": "0009-0006-2382-9286"
    },
    {
      "affs": [
        0
      ],
      "name": "Takeshi Iizuka"
    },
    {
      "affs": [
        0
      ],
      "name": "Shin Yagi"
    },
    {
      "affs": [
        0
      ],
      "name": "Yusuke Kurita"
    },
    {
      "affs": [
        0
      ],
      "name": "Kensuke Kubota"
    },
    {
      "affs": [
        0
      ],
      "name": "Masato Yoneda"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/6jhkj0cnarh8a.bib",
  "cited_by": 0,
  "doi": "10.1136/bmjopen-2026-124622",
  "fulltext_url": null,
  "id": "6jhkj0cnarh8a",
  "issns": [
    "2044-6055",
    "2044-6055"
  ],
  "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124622",
  "language": null,
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
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      "openalex",
      "2740|Gallbladder and Bile Duct Disorders"
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  "pdf_url": "https://bmjopen.bmj.com/content/bmjopen/16/10/e124622.full.pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-07",
  "publisher": "BMJ",
  "ris": "https://research.draconitic.com/paper/6jhkj0cnarh8a.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:44Z",
      "native_id": "10.1136/bmjopen-2026-124622",
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2740|Gallbladder and Bile Duct Disorders",
      "subfield": "general"
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  ],
  "title": "Short-term prophylactic biliary stenting after complete common bile duct stone removal to prevent post-ERCP cholangitis in Japan (STEP-ERCP study): study protocol for a confirmatory multicentre randomised controlled trial",
  "title_text": "Short-term prophylactic biliary stenting after complete common bile duct stone removal to prevent post-ERCP cholangitis in Japan (STEP-ERCP study): study protocol for a confirmatory multicentre randomised controlled trial",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:19:44Z",
  "url": "https://research.draconitic.com/paper/6jhkj0cnarh8a",
  "venue": "BMJ Open",
  "versions": []
}