Journal Article

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

Kurita, Yusuke, Nagashio, Yoshikuni, Yagi, Shin, Ishida, Yusuke, Kuwada, Masaru, Ishiwatari, Hirotoshi, Komori, Yasuhiro, Fukuda, Souma, Okamoto, Kohei, Ushio, Jun, Hasegawa, Sho, Takeshita, Kotaro, Agarie, Daiki, Harai, Shota, Yoshino, Kohei, Kubota, Kensuke, Yamashige, Daiki, Hijioka, Susumu, Okusaka, Takuji

2025

Overview

IntroductionPreoperative 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 analysisThis 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 disseminationThis 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 numberUMIN ID: 000055173.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Bile ducts / Cancer therapies / Chemotherapy / Cholangiopancreatography, Endoscopic Retrograde / Cholangitis / Cholestasis - etiology / Cholestasis - surgery / Clinical trials / Consent / Drainage - methods / Endoscopy / Endosonography - methods / Gastroenterology and Hepatology / Gastrostomy - methods / Hepatobiliary disease / Hospitals / Humans / Japan / Jaundice / Male / Multicenter Studies as Topic / Observational Studies as Topic / Pancreatic cancer / Pancreatic disease / Pancreatic Neoplasms - complications / Pancreatic Neoplasms - surgery / Pancreatitis / Patients / Preoperative Care - methods / Prospective Studies / Protocol / Registration / Stents / Surgery / Surgical outcomes / Ultrasonic imaging / Ultrasonography, Interventional