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WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts
Sponsor: Tokyo University
Summary
Endoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), the use of a LAMS is limited by its high costs and specific adverse events compared to plastic stent placement. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts.
Official title: WONDER-02: Plastic Stent vs. Lumen-apposing Metal Stent for Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts-a Multicentre Randomised Non-inferiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-11
Completion Date
2033-09
Last Updated
2023-11-15
Healthy Volunteers
No
Interventions
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.
Locations (26)
Department of Gastroenterology, Aichi Medical University
Aichi, Japan
Department of Gastroenterology, The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Bunkyō-Ku, Tokyo, Japan
Department of Gastroenterology, Graduate School of Medicine, Chiba University
Chiba, Japan
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
Fukuoka, Japan
Department of Gastroenterology, Gifu Municipal Hospital
Gifu, Japan
Department of Gastroenterology, Gifu Prefectural General Medical Center
Gifu, Japan
First Department of Internal Medicine, Gifu University Hospital
Gifu, Japan
Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University
Hyōgo, Japan
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Kagawa, Japan
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences
Kagoshima, Japan
Department of Gastroenterology, Kameda Medical Center
Kamogawa, Japan
Department of Gastroenterology, St. Marianna University School of Medicine
Kanagawa, Japan
Department of Gastroenterological Endoscopy, Kanazawa Medical University
Kanazawa, Japan
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
Kawagoe, Japan
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
Kawasaki, Japan
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Kobe, Japan
Department of Gastroenterology and Hepatology, Mie University Hospital
Mie, Japan
Department of Gastroenterology and Hepatology, Okayama University Hospital
Okayama, Japan
2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University
Osaka, Japan
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Ōsaka, Japan
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Sapporo, Japan
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Tokyo, Japan
Third Department of Internal Medicine, University of Toyama
Toyama, Japan
Department of Gastroenterology, Wakayama Medical University School of Medicine
Wakayama, Japan
Department of Gastroenterology, Yamanashi Prefectural Central Hospital
Yamanashi, Japan