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Peer-reviewedCC BY-NC 4.0BMJ Open

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

  • Sho Hasegawa1
  • Yoshihide Kanno2
  • Satoru Shinoda3
  • Shinichi Nihei4
  • Yusuke Sekino5
  • Yuji Fujita6
  • Kunihiro Hosono7
  • Takamitsu Sato8
  • Yasunari Sakamoto9
  • Takaomi Kessoku10
  • Akito Iwasaki11
  • Takuya Takayanagi12
8 more authors
  • Tomoki Ogata13
  • Yu Honda1
  • Takayuki Oda1
  • Takeshi Iizuka1
  • Shin Yagi1
  • Yusuke Kurita1
  • Kensuke Kubota1
  • Masato Yoneda1
13 affiliations
  1. 1Gastroenterology and Hepatology, Yokohama City University Hospital, Yokohama, Japan
  2. 2Department of Gastroenterology, Sendai City Medical Center, Sendai, Japan
  3. 3Department of Biostatistics, Yokohama City University, Yokohama, Kanagawa, Japan
  4. 4Department of Gastroenterology, National Hospital Organization Yokohama Medical, Yokohama, Japan
  5. 5Department of Gastroenterology, Yokohama Rosai Hospital, Yokohama, Japan
  6. 6Department of Hepato-Biliary-Pancreatic Medicine, NTT Medical Center Tokyo, Tokyo, Japan
  7. 7Department of Gastroenterology, Yokosuka General Medical Center, Kanagawa, Japan
  8. 8Department of Gastroenterology, Chigasaki Municipal Hospital, Kanagawa, Japan
  9. 9Department of Gastroenterology and Hepatology, International University of Health and Welfare Atami Hospital, Shizuoka, Japan
  10. 10Department of Palliative Medicine, International University of Health and Welfare Narita Hospital, Chiba, Japan
  11. 11Department of Gastroenterology, Yokohama Sakae Kyosai Hospital, Yokohama, Japan
  12. 12Department of Gastroenterology, Omori Red Cross Hospital, Tokyo, Japan
  13. 13Department of Gastroenterology, International University of Health and Welfare Narita Hospital, Chiba, Japan
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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.

Methods 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.

Ethics 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.

The 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.

Written informed consent will be obtained from all participants.

Study findings will be disseminated through peer-reviewed publications and scientific conferences.

Trial registration number: jRCT1032260128

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Cite

BibTeXRIS
BibTeX
@article{hasegawa2026shortterm,
  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}},
  author = {Sho Hasegawa and Yoshihide Kanno and Satoru Shinoda and Shinichi Nihei and Yusuke Sekino and Yuji Fujita and Kunihiro Hosono and Takamitsu Sato and Yasunari Sakamoto and Takaomi Kessoku and Akito Iwasaki and Takuya Takayanagi and Tomoki Ogata and Yu Honda and Takayuki Oda and Takeshi Iizuka and Shin Yagi and Yusuke Kurita and Kensuke Kubota and Masato Yoneda},
  journal = {BMJ Open},
  year = {2026},
  month = oct,
  doi = {10.1136/bmjopen-2026-124622},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124622},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - 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
AU  - Sho Hasegawa
AU  - Yoshihide Kanno
AU  - Satoru Shinoda
AU  - Shinichi Nihei
AU  - Yusuke Sekino
AU  - Yuji Fujita
AU  - Kunihiro Hosono
AU  - Takamitsu Sato
AU  - Yasunari Sakamoto
AU  - Takaomi Kessoku
AU  - Akito Iwasaki
AU  - Takuya Takayanagi
AU  - Tomoki Ogata
AU  - Yu Honda
AU  - Takayuki Oda
AU  - Takeshi Iizuka
AU  - Shin Yagi
AU  - Yusuke Kurita
AU  - Kensuke Kubota
AU  - Masato Yoneda
PY  - 2026
DA  - 2026/10/07
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-124622
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124622
AB  - 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.  Methods 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.  Ethics 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.  The 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.  Written informed consent will be obtained from all participants.  Study findings will be disseminated through peer-reviewed publications and scientific conferences.  Trial registration number: jRCT1032260128
SN  - 2044-6055
SN  - 2044-6055
ER  -