80
Participants
Start Date
November 30, 2023
Primary Completion Date
October 31, 2026
Study Completion Date
September 30, 2033
Plastic stent
"EUS-guided drainage will be conducted under endosonographic and fluoroscopic guidance within 72 hours of the randomisation. A linear echoendoscope will be advanced to the stomach or duodenum with moderate sedation, and the targeted pseudocyst will be visualised and punctured under endosonographic guidance. In cases with an insufficient improvement in inflammatory indicators (i.e., body temperature, white blood cell count, and C-reactive protein), the investigators will perform additional interventions including the addition of or replacement with a plastic stent or LAMS and/or percutaneous drainage if needed.~In the plastic stent group, two (at least one) 7-Fr double pigtail stents will be placed. Following EUS-guided puncture of a pseudocyst, a guidewire will be coiled within the lesion, and another guidewire will be inserted alongside the prepositioned guidewire. The puncture tract will be dilated if needed."
LAMS
"EUS-guided drainage will be conducted under endosonographic and fluoroscopic guidance within 72 hours of the randomisation. A linear echoendoscope will be advanced to the stomach or duodenum with moderate sedation, and the targeted pseudocyst will be visualised and punctured under endosonographic guidance. In cases with an insufficient improvement in inflammatory indicators (i.e., body temperature, white blood cell count, and C-reactive protein), the investigators will perform additional interventions including the addition of or replacement with a plastic stent or LAMS and/or percutaneous drainage if needed.~In the LAMS group, a LAMS with electrocautery enhanced delivery will be placed (Hot AXIOS; Boston Scientific Japan, Tokyo, Japan). A guidewire or dilator will be used if needed."
Department of Gastroenterology, Aichi Medical University, Aichi
Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Bunkyō-Ku, Tokyo
Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka
Department of Gastroenterology, Gifu Municipal Hospital, Gifu
Department of Gastroenterology, Gifu Prefectural General Medical Center, Gifu
First Department of Internal Medicine, Gifu University Hospital, Gifu
Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University, Hyōgo
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Kagawa
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima
Department of Gastroenterology, Kameda Medical Center, Kamogawa
Department of Gastroenterology, St. Marianna University School of Medicine, Kanagawa
Department of Gastroenterological Endoscopy, Kanazawa Medical University, Kanazawa
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University, Kawagoe
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe
Department of Gastroenterology and Hepatology, Mie University Hospital, Mie
Department of Gastroenterology and Hepatology, Okayama University Hospital, Okayama
2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Ōsaka
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo
Third Department of Internal Medicine, University of Toyama, Toyama
Department of Gastroenterology, Wakayama Medical University School of Medicine, Wakayama
Department of Gastroenterology, Yamanashi Prefectural Central Hospital, Yamanashi
Department of Gastroenterology, The University of Tokyo Hospital, Bunkyō-Ku, Tokyo
Tokyo University
OTHER