{
  "abstract": "Introduction Preoperative biliary drainage (PBD) is often required for patients with pancreatic cancer accompanied by biliary obstruction to ensure the safe administration of neoadjuvant chemotherapy or to manage cholangitis and jaundice. Although endoscopic retrograde cholangiopancreatography (ERCP) is the standard approach for PBD, it carries a significant risk of post-ERCP pancreatitis. Endoscopic ultrasound-guided biliary drainage (EUS-BD), particularly via hepaticogastrostomy (EUS-HGS), offers a promising alternative that avoids papillary manipulation. However, the clinical utility of EUS-BD as primary drainage for PBD remains unclear due to a lack of prospective studies. This multicentre prospective trial aims to evaluate the safety and efficacy of EUS-HGS as primary drainage for PBD in patients with resectable or borderline resectable pancreatic cancer.Methods and analysis This multicentre prospective study involves seven institutions in Japan. Eligible patients will undergo EUS-HGS using a 7Fr plastic stent. The primary endpoint is clinical success, defined by improvements in bilirubin or liver enzyme levels within 14 days postprocedure. Secondary endpoints include technical success rate, adverse event incidence, stent patency and surgical outcomes. A total of 30 patients will be enrolled, considering an expected clinical success rate of 90% and a 10% dropout allowance.Ethics and dissemination This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2024-084). The results of this study will be reported at an international conference and published in an international peer-reviewed journal.Trial registration number UMIN ID: 000055173.",
  "authors": [
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan",
        "Department of Gastroenterology and Hepatology, Yokohama City University Hospital, Yokohama, Japan"
      ],
      "name": "Shin Yagi"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Susumu Hijioka"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Yoshikuni Nagashio"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Shota Harai"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Daiki Agarie"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Daiki Yamashige"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Kohei Okamoto"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Souma Fukuda"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Masaru Kuwada"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Yasuhiro Komori"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Yokohama City University Hospital, Yokohama, Japan"
      ],
      "name": "Yusuke Kurita"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Yokohama City University Hospital, Yokohama, Japan"
      ],
      "name": "Sho Hasegawa"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Yokohama City University Hospital, Yokohama, Japan"
      ],
      "name": "Kensuke Kubota"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan"
      ],
      "name": "Yusuke Ishida"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Showa Medical University Koto Toyosu Hospital, Tokyo, Japan"
      ],
      "name": "Jun Ushio"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Tane General Hospital, Osaka, Japan"
      ],
      "name": "Kotaro Takeshita"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Yokohama City Minato Red Cross Hospital, Yokohama, Japan"
      ],
      "name": "Kohei Yoshino"
    },
    {
      "affiliations": [
        "Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan"
      ],
      "name": "Hirotoshi Ishiwatari"
    },
    {
      "affiliations": [
        "Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan"
      ],
      "name": "Takuji Okusaka"
    }
  ],
  "title": "Prospective, multicentre trial on preoperative biliary drainage by endoscopic ultrasound-guided hepaticogastrostomy for resectable/borderline resectable pancreatic cancer with biliary obstruction: the PROLOGUE study – a study protocol",
  "uid": "0758528b-9ac1-5bd8-abdb-b450ea16f4c5"
}