[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526306":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":369,"collaborators":26,"id":371,"slug":372,"hasResults":373,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":26,"eligibilityCriteria":377,"healthyVolunteers":373,"sex":378,"minAge":379,"maxAge":26,"enrollmentInfo":380,"targetDuration":26,"studyType":383,"phases":384,"briefSummary":386,"conditions":387,"keywords":391,"overallStatus":395,"whyStopped":26,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":405},{"fullName":5,"class":6},"Tokyo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Plastic stent group","EXPERIMENTAL","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.",[13],"Procedure: Plastic stent",{"label":15,"type":16,"description":17,"interventionNames":18},"LAMS group","ACTIVE_COMPARATOR","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.",[19],"Procedure: LAMS",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","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\u002For percutaneous drainage if needed.\n\nIn 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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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\u002For percutaneous drainage if needed.\n\nIn 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.",[15],[32],{"name":33,"affiliation":34,"role":35},"Yousuke Nakai","Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+81-3-3815-5411","ynakai-tky@umin.ac.jp",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Tomotaka Saito","tomsaito-gi@umin.ac.jp",[45,59,66,76,89,102,115,125,135,148,161,174,187,200,211,224,237,252,265,280,293,306,319,332,345,358],{"facility":46,"status":26,"city":47,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Department of Gastroenterology, Aichi Medical University","Aichi","Japan","JP",{"type":51,"coordinates":52},"Point",[53,54],130.62158,32.51879,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":26,"phoneExt":26,"email":26},"Tadahisa Inoue",{"facility":60,"status":26,"city":61,"state":26,"zip":62,"country":48,"countryCode":49,"cosmosGeoPoint":26,"geoPoint":26,"contacts":63},"Department of Gastroenterology, The University of Tokyo Hospital","Bunkyō-Ku, Tokyo","113-8655",[64,65],{"name":33,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},{"facility":67,"status":26,"city":61,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":26,"geoPoint":26,"contacts":68},"Department of Gastroenterology, Graduate School of Medicine, Juntendo University",[69,71,73],{"name":70,"role":38,"phone":26,"phoneExt":26,"email":26},"Hiroyuki Isayama",{"name":72,"role":38,"phone":26,"phoneExt":26,"email":26},"Toshio Fujisawa",{"name":74,"role":75,"phone":26,"phoneExt":26,"email":26},"Sho Takahashi","SUB_INVESTIGATOR",{"facility":77,"status":26,"city":78,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Department of Gastroenterology, Graduate School of Medicine, Chiba University","Chiba",{"type":51,"coordinates":80},[81,82],140.11667,35.6,{"lat":82,"lon":81},[85,87],{"name":86,"role":38,"phone":26,"phoneExt":26,"email":26},"Hiroshi Ohyama",{"name":88,"role":38,"phone":26,"phoneExt":26,"email":26},"Koji Takahashi",{"facility":90,"status":26,"city":91,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University","Fukuoka",{"type":51,"coordinates":93},[94,95],130.41667,33.6,{"lat":95,"lon":94},[98,100],{"name":99,"role":38,"phone":26,"phoneExt":26,"email":26},"Nao Fujimori",{"name":101,"role":38,"phone":26,"phoneExt":26,"email":26},"Kazuhide Matsumoto",{"facility":103,"status":26,"city":104,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Department of Gastroenterology, Gifu Municipal Hospital","Gifu",{"type":51,"coordinates":106},[107,108],136.76039,35.42291,{"lat":108,"lon":107},[111,113],{"name":112,"role":38,"phone":26,"phoneExt":26,"email":26},"Keisuke Iwata",{"name":114,"role":38,"phone":26,"phoneExt":26,"email":26},"Mitsuru Okuno",{"facility":116,"status":26,"city":104,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":117,"geoPoint":119,"contacts":120},"Department of Gastroenterology, Gifu Prefectural General Medical Center",{"type":51,"coordinates":118},[107,108],{"lat":108,"lon":107},[121,123],{"name":122,"role":38,"phone":26,"phoneExt":26,"email":26},"Akinori Maruta",{"name":124,"role":38,"phone":26,"phoneExt":26,"email":26},"Kensaku Yoshida",{"facility":126,"status":26,"city":104,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":127,"geoPoint":129,"contacts":130},"First Department of Internal Medicine, Gifu University Hospital",{"type":51,"coordinates":128},[107,108],{"lat":108,"lon":107},[131,133],{"name":132,"role":38,"phone":26,"phoneExt":26,"email":26},"Takuji Iwashita",{"name":134,"role":38,"phone":26,"phoneExt":26,"email":26},"Shinya Uemura",{"facility":136,"status":26,"city":137,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University","Hyōgo",{"type":51,"coordinates":139},[140,141],144.43333,43.36667,{"lat":141,"lon":140},[144,146],{"name":145,"role":38,"phone":26,"phoneExt":26,"email":26},"Hideyuki Shiomi",{"name":147,"role":38,"phone":26,"phoneExt":26,"email":26},"Ryota Nakano",{"facility":149,"status":26,"city":150,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University","Kagawa",{"type":51,"coordinates":152},[153,154],131.03333,34.06667,{"lat":154,"lon":153},[157,159],{"name":158,"role":38,"phone":26,"phoneExt":26,"email":26},"Hideki Kamada",{"name":160,"role":38,"phone":26,"phoneExt":26,"email":26},"Ryota Nakabayashi",{"facility":162,"status":26,"city":163,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences","Kagoshima",{"type":51,"coordinates":165},[166,167],130.55,31.56667,{"lat":167,"lon":166},[170,172],{"name":171,"role":38,"phone":26,"phoneExt":26,"email":26},"Shinichi Hashimoto",{"name":173,"role":38,"phone":26,"phoneExt":26,"email":26},"Makoto Hinokuchi",{"facility":175,"status":26,"city":176,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Department of Gastroenterology, Kameda Medical Center","Kamogawa",{"type":51,"coordinates":178},[179,180],140.1003,35.0969,{"lat":180,"lon":179},[183,185],{"name":184,"role":38,"phone":26,"phoneExt":26,"email":26},"Toshiyasu Shiratori",{"name":186,"role":38,"phone":26,"phoneExt":26,"email":26},"So Nakaji",{"facility":188,"status":26,"city":189,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Department of Gastroenterology, St. Marianna University School of Medicine","Kanagawa",{"type":51,"coordinates":191},[192,193],139.91667,37.58333,{"lat":193,"lon":192},[196,198],{"name":197,"role":38,"phone":26,"phoneExt":26,"email":26},"Kazunari Nakahara",{"name":199,"role":38,"phone":26,"phoneExt":26,"email":26},"Yusuke Satta",{"facility":201,"status":26,"city":202,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Department of Gastroenterological Endoscopy, Kanazawa Medical University","Kanazawa",{"type":51,"coordinates":204},[205,206],136.61667,36.6,{"lat":206,"lon":205},[209],{"name":210,"role":38,"phone":26,"phoneExt":26,"email":26},"Tsuyoshi Mukai",{"facility":212,"status":26,"city":213,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University","Kawagoe",{"type":51,"coordinates":215},[216,217],139.48528,35.90861,{"lat":217,"lon":216},[220,222],{"name":221,"role":38,"phone":26,"phoneExt":26,"email":26},"Saburo Matsubara",{"name":223,"role":38,"phone":26,"phoneExt":26,"email":26},"Kentaro Suda",{"facility":225,"status":26,"city":226,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Department of Gastroenterology, Teikyo University Mizonokuchi Hospital","Kawasaki",{"type":51,"coordinates":228},[229,230],139.71722,35.52056,{"lat":230,"lon":229},[233,235],{"name":234,"role":38,"phone":26,"phoneExt":26,"email":26},"Shinpei Doi",{"name":236,"role":38,"phone":26,"phoneExt":26,"email":26},"Nobuhiro Katsukura",{"facility":238,"status":26,"city":239,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine","Kobe",{"type":51,"coordinates":241},[242,243],135.183,34.6913,{"lat":243,"lon":242},[246,248,250],{"name":247,"role":38,"phone":26,"phoneExt":26,"email":26},"Atsuhiro Masuda",{"name":249,"role":38,"phone":26,"phoneExt":26,"email":26},"Arata Sakai",{"name":251,"role":75,"phone":26,"phoneExt":26,"email":26},"Masahiro Tsujimae",{"facility":253,"status":26,"city":254,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Department of Gastroenterology and Hepatology, Mie University Hospital","Mie",{"type":51,"coordinates":256},[257,258],131.58333,32.96667,{"lat":258,"lon":257},[261,263],{"name":262,"role":38,"phone":26,"phoneExt":26,"email":26},"Reiko Yamada",{"name":264,"role":38,"phone":26,"phoneExt":26,"email":26},"Kenji Nose",{"facility":266,"status":26,"city":267,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Department of Gastroenterology and Hepatology, Okayama University Hospital","Okayama",{"type":51,"coordinates":269},[270,271],133.93333,34.65,{"lat":271,"lon":270},[274,276,278],{"name":275,"role":38,"phone":26,"phoneExt":26,"email":26},"Hironari Kato",{"name":277,"role":38,"phone":26,"phoneExt":26,"email":26},"Kazuyuki Matsumoto",{"name":279,"role":75,"phone":26,"phoneExt":26,"email":26},"Ryosuke Sato",{"facility":281,"status":26,"city":282,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University","Osaka",{"type":51,"coordinates":284},[285,286],135.50107,34.69379,{"lat":286,"lon":285},[289,291],{"name":290,"role":38,"phone":26,"phoneExt":26,"email":26},"Takeshi Ogura",{"name":292,"role":38,"phone":26,"phoneExt":26,"email":26},"Saori Ueno",{"facility":294,"status":26,"city":295,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine","Ōsaka",{"type":51,"coordinates":297},[298,299],138.04138,34.66751,{"lat":299,"lon":298},[302,304],{"name":303,"role":38,"phone":26,"phoneExt":26,"email":26},"Mamoru Takenaka",{"name":305,"role":38,"phone":26,"phoneExt":26,"email":26},"Shunsuke Omoto",{"facility":307,"status":26,"city":308,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Department of Gastroenterology and Hepatology, Hokkaido University Hospital","Sapporo",{"type":51,"coordinates":310},[311,312],141.35,43.06667,{"lat":312,"lon":311},[315,317],{"name":316,"role":38,"phone":26,"phoneExt":26,"email":26},"Masaki Kuwatani",{"name":318,"role":38,"phone":26,"phoneExt":26,"email":26},"Ryou Sugiura",{"facility":320,"status":26,"city":321,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine","Tokyo",{"type":51,"coordinates":323},[324,325],139.69171,35.6895,{"lat":325,"lon":324},[328,330],{"name":329,"role":38,"phone":26,"phoneExt":26,"email":26},"Hirofumi Kogure",{"name":331,"role":38,"phone":26,"phoneExt":26,"email":26},"Kei Saito",{"facility":333,"status":26,"city":334,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"Third Department of Internal Medicine, University of Toyama","Toyama",{"type":51,"coordinates":336},[337,338],137.21667,36.7,{"lat":338,"lon":337},[341,343],{"name":342,"role":38,"phone":26,"phoneExt":26,"email":26},"Ichiro Yasuda",{"name":344,"role":38,"phone":26,"phoneExt":26,"email":26},"Nobuhiko Hayashi",{"facility":346,"status":26,"city":347,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":348,"geoPoint":352,"contacts":353},"Department of Gastroenterology, Wakayama Medical University School of Medicine","Wakayama",{"type":51,"coordinates":349},[350,351],135.16667,34.23333,{"lat":351,"lon":350},[354,356],{"name":355,"role":38,"phone":26,"phoneExt":26,"email":26},"Masayuki Kitano",{"name":357,"role":38,"phone":26,"phoneExt":26,"email":26},"Takashi Tamura",{"facility":359,"status":26,"city":360,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":361,"geoPoint":365,"contacts":366},"Department of Gastroenterology, Yamanashi Prefectural Central Hospital","Yamanashi",{"type":51,"coordinates":362},[363,364],138.69827,35.67152,{"lat":364,"lon":363},[367],{"name":368,"role":38,"phone":26,"phoneExt":26,"email":26},"Sumio Hirose",{"type":35,"investigatorFullName":33,"investigatorTitle":370,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Associate professor, Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital","100526306","wonder-02-trial-plastic-stent-vs-lumen-apposing-metal-stent-for-pancreatic-pseudocysts-100526306",false,"NCT06133023","WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts","WONDER-02: Plastic Stent vs. Lumen-apposing Metal Stent for Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts-a Multicentre Randomised Non-inferiority Trial","Inclusion Criteria:\n\n* Patients with pancreatic pseudocyst(s) defined by the revised Atlanta classification\n* The longest diameter of a targeted pseudocyst ≥ 5 cm\n* Patients requiring drainage for symptoms associated with a pseudocyst (e.g., infection, gastrointestinal symptoms including abdominal pain, or jaundice)\n* Patients aged 18 years or older\n* Written informed consent obtained from patients or their representatives\n\nExclusion Criteria:\n\n* A pseudocyst that is inaccessible via the EUS-guided approach\n* A plastic or lumen-apposing metal stent in situ\n* Coagulopathy (e.g., platelet count \\\u003C 50,000\u002Fmm3 or prothrombin time international normalised ratio \\[PT-INR\\] \\>1.5)\n* Users of antithrombotic agents that cannot be discontinued according to the Japan Gastroenterological Endoscopy Society \\[JGES\\] guidelines\n* Patients who do not tolerate endoscopic procedures\n* Pregnant women","ALL","18 Years",{"count":381,"type":382},80,"ESTIMATED","INTERVENTIONAL",[385],"NA","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.",[388,389,390],"Pancreatic Fluid Collection","Pancreatitis","Pancreatic Pseudocyst",[392,393,394,390],"Endosonography","Drainage","Stents","NOT_YET_RECRUITING","2023-11-09",{"date":398,"type":399},"2023-11-15","ACTUAL",{"date":401,"type":382},"2023-11",{"date":403,"type":382},"2033-09",{"name":5,"class":6},26]