[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473977":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":300,"collaborators":25,"id":302,"slug":303,"hasResults":304,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":304,"sex":310,"minAge":311,"maxAge":25,"enrollmentInfo":312,"targetDuration":25,"studyType":315,"phases":316,"briefSummary":318,"conditions":319,"keywords":324,"overallStatus":56,"whyStopped":25,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":338},{"fullName":5,"class":6},"Tokyo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate necrosectomy","EXPERIMENTAL","Endoscopic necrosectomy will be conducted in the same session of EUS-guided drainage (or at least within 72 hours of randomization) and be repeated until clinical success.",[13],"Procedure: Immediate necrosectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Step-up approach","ACTIVE_COMPARATOR","Step-up treatment will be conducted if a patient's condition does not improve after EUS-guided drainage. The step-up approach includes increasing the number of stents, adding another EUS-guided drainage, and performing percutaneous drainage after 72-96 hours of the initial drainage. Endoscopic necrosectomy is considered when clinical improvement is not observed even after two times of step-up treatment.",[19],"Procedure: Step-up approach",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage.\n\nFor the immediate necrosectomy group, endoscopic necrosectomy (EN) will be performed in the same session of EUS-guided drainage using a gastroscope. The endoscope is inserted into the WON cavity through the LAMS, and necrotic tissue is removed using biopsy forceps, snare, or basket catheter. The EN procedures will be repeated until clinical improvement.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage.\n\nFor the step-up approach group, an additional interventional procedure will be withheld for 72-96 hours after initial EUS-guided drainage. In cases without clinical improvement after 72-96 hours, additional drainage will be permitted, which includes increasing the number of stents, additional EUS-guided drainage, and performing percutaneous drainage (step-up treatment). Insufficient improvement even after two times of step-up treatment allows subsequent endoscopic necrosectomy (EN).",[15],[30],{"name":31,"affiliation":32,"role":33},"Yousuke Nakai","Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+81-3-3815-5411","ynakai-tky@umin.ac.jp",{"name":40,"role":36,"phone":37,"phoneExt":25,"email":41},"Tomotaka Saito","tomsaito-gi@umin.ac.jp",[43,54,65,77,90,103,113,123,138,151,164,177,188,201,214,227,238,251,264,275,287],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":25,"geoPoint":25,"contacts":51},"Department of Gastroenterology, The University of Tokyo Hospital","NOT_YET_RECRUITING","Bunkyō-Ku","Tokyo","113-8655","Japan","JP",[52,53],{"name":31,"role":36,"phone":25,"phoneExt":25,"email":25},{"name":40,"role":36,"phone":37,"phoneExt":25,"email":41},{"facility":55,"status":56,"city":46,"state":47,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":25,"geoPoint":25,"contacts":57},"Department of Gastroenterology, Graduate School of Medicine, Juntendo University","RECRUITING",[58,60,62],{"name":59,"role":36,"phone":25,"phoneExt":25,"email":25},"Hiroyuki Isayama",{"name":61,"role":36,"phone":25,"phoneExt":25,"email":25},"Toshio Fujisawa",{"name":63,"role":64,"phone":25,"phoneExt":25,"email":25},"Sho Takahashi","SUB_INVESTIGATOR",{"facility":66,"status":56,"city":67,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Department of Gastroenterology, Aichi Medical University","Aichi",{"type":69,"coordinates":70},"Point",[71,72],130.62158,32.51879,{"lat":72,"lon":71},[75],{"name":76,"role":36,"phone":25,"phoneExt":25,"email":25},"Tadahisa Inoue",{"facility":78,"status":56,"city":79,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Department of Gastroenterology, Graduate School of Medicine, Chiba University","Chiba",{"type":69,"coordinates":81},[82,83],140.11667,35.6,{"lat":83,"lon":82},[86,88],{"name":87,"role":36,"phone":25,"phoneExt":25,"email":25},"Hiroshi Ohyama",{"name":89,"role":36,"phone":25,"phoneExt":25,"email":25},"Koji Takahashi",{"facility":91,"status":56,"city":92,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Department of Gastroenterology, Gifu Municipal Hospital","Gifu",{"type":69,"coordinates":94},[95,96],136.76039,35.42291,{"lat":96,"lon":95},[99,101],{"name":100,"role":36,"phone":25,"phoneExt":25,"email":25},"Keisuke Iwata",{"name":102,"role":36,"phone":25,"phoneExt":25,"email":25},"Mitsuru Okuno",{"facility":104,"status":56,"city":92,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Department of Gastroenterology, Gifu Prefectural General Medical Center",{"type":69,"coordinates":106},[95,96],{"lat":96,"lon":95},[109,111],{"name":110,"role":36,"phone":25,"phoneExt":25,"email":25},"Akinori Maruta",{"name":112,"role":36,"phone":25,"phoneExt":25,"email":25},"Kensaku Yoshida",{"facility":114,"status":45,"city":92,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"First Department of Internal Medicine, Gifu University Hospital",{"type":69,"coordinates":116},[95,96],{"lat":96,"lon":95},[119,121],{"name":120,"role":36,"phone":25,"phoneExt":25,"email":25},"Takuji Iwashita",{"name":122,"role":36,"phone":25,"phoneExt":25,"email":25},"Shinya Uemura",{"facility":124,"status":56,"city":125,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University","Hyōgo",{"type":69,"coordinates":127},[128,129],144.43333,43.36667,{"lat":129,"lon":128},[132,134,136],{"name":133,"role":36,"phone":25,"phoneExt":25,"email":25},"Hideyuki Shiomi",{"name":135,"role":36,"phone":25,"phoneExt":25,"email":25},"Shogo Ota",{"name":137,"role":64,"phone":25,"phoneExt":25,"email":25},"Ryota Nakano",{"facility":139,"status":56,"city":140,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University","Kagawa",{"type":69,"coordinates":142},[143,144],131.03333,34.06667,{"lat":144,"lon":143},[147,149],{"name":148,"role":36,"phone":25,"phoneExt":25,"email":25},"Hideki Kamada",{"name":150,"role":36,"phone":25,"phoneExt":25,"email":25},"Daisuke Namima",{"facility":152,"status":56,"city":153,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences","Kagoshima",{"type":69,"coordinates":155},[156,157],130.55,31.56667,{"lat":157,"lon":156},[160,162],{"name":161,"role":36,"phone":25,"phoneExt":25,"email":25},"Shinichi Hashimoto",{"name":163,"role":36,"phone":25,"phoneExt":25,"email":25},"Makoto Hinokuchi",{"facility":165,"status":56,"city":166,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Department of Gastroenterology, Kameda Medical Center","Kamogawa",{"type":69,"coordinates":168},[169,170],140.1003,35.0969,{"lat":170,"lon":169},[173,175],{"name":174,"role":36,"phone":25,"phoneExt":25,"email":25},"Toshiyasu Shiratori",{"name":176,"role":36,"phone":25,"phoneExt":25,"email":25},"So Nakaji",{"facility":178,"status":45,"city":179,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Department of Gastroenterological Endoscopy, Kanazawa Medical University","Kanazawa",{"type":69,"coordinates":181},[182,183],136.61667,36.6,{"lat":183,"lon":182},[186],{"name":187,"role":36,"phone":25,"phoneExt":25,"email":25},"Tsuyoshi Mukai",{"facility":189,"status":45,"city":190,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University","Kawagoe",{"type":69,"coordinates":192},[193,194],139.48528,35.90861,{"lat":194,"lon":193},[197,199],{"name":198,"role":36,"phone":25,"phoneExt":25,"email":25},"Saburo Matsubara",{"name":200,"role":36,"phone":25,"phoneExt":25,"email":25},"Keito Nakagawa",{"facility":202,"status":45,"city":203,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Department of Gastroenterology, Teikyo University Mizonokuchi Hospital","Kawasaki",{"type":69,"coordinates":205},[206,207],139.71722,35.52056,{"lat":207,"lon":206},[210,212],{"name":211,"role":36,"phone":25,"phoneExt":25,"email":25},"Shinpei Doi",{"name":213,"role":36,"phone":25,"phoneExt":25,"email":25},"Nobuhiro Katsukura",{"facility":215,"status":56,"city":216,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine","Kobe",{"type":69,"coordinates":218},[219,220],135.183,34.6913,{"lat":220,"lon":219},[223,225],{"name":224,"role":36,"phone":25,"phoneExt":25,"email":25},"Atsuhiro Masuda",{"name":226,"role":36,"phone":25,"phoneExt":25,"email":25},"Masahiro Tsujimae",{"facility":228,"status":56,"city":229,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Department of Gastroenterology, Yuuai Medical Center","Okinawa",{"type":69,"coordinates":231},[232,233],127.80139,26.33583,{"lat":233,"lon":232},[236],{"name":237,"role":36,"phone":25,"phoneExt":25,"email":25},"Kenji Chinen",{"facility":239,"status":45,"city":240,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"2nd Department of Internal Medicine, Osaka Medical College","Osaka",{"type":69,"coordinates":242},[243,244],135.50107,34.69379,{"lat":244,"lon":243},[247,249],{"name":248,"role":36,"phone":25,"phoneExt":25,"email":25},"Takeshi Ogura",{"name":250,"role":36,"phone":25,"phoneExt":25,"email":25},"Atsushi Okuda",{"facility":252,"status":45,"city":253,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine","Ōsaka-sayama",{"type":69,"coordinates":255},[256,257],135.55069,34.49524,{"lat":257,"lon":256},[260,262],{"name":261,"role":36,"phone":25,"phoneExt":25,"email":25},"Mamoru Takenaka",{"name":263,"role":36,"phone":25,"phoneExt":25,"email":25},"Shunsuke Omoto",{"facility":265,"status":56,"city":266,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Department of Gastroenterology and Hepatology, Hokkaido University Hospital","Sapporo",{"type":69,"coordinates":268},[269,270],141.35,43.06667,{"lat":270,"lon":269},[273],{"name":274,"role":36,"phone":25,"phoneExt":25,"email":25},"Masaki Kuwatani",{"facility":276,"status":45,"city":47,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine",{"type":69,"coordinates":278},[279,280],139.69171,35.6895,{"lat":280,"lon":279},[283,285],{"name":284,"role":36,"phone":25,"phoneExt":25,"email":25},"Hirofumi Kogure",{"name":286,"role":36,"phone":25,"phoneExt":25,"email":25},"Kei Saito",{"facility":288,"status":56,"city":289,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"Third Department of Internal Medicine, University of Toyama","Toyama",{"type":69,"coordinates":291},[292,293],137.21667,36.7,{"lat":293,"lon":292},[296,298],{"name":297,"role":36,"phone":25,"phoneExt":25,"email":25},"Ichiro Yasuda",{"name":299,"role":36,"phone":25,"phoneExt":25,"email":25},"Nobuhiko Hayashi",{"type":33,"investigatorFullName":31,"investigatorTitle":301,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Associate professor, Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital","100473977","immediate-necrosectomy-vs-step-up-approach-for-walled-off-necrosis-100473977",false,"NCT05451901","Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis","Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)","WONDER-01","Inclusion Criteria:\n\n* Patients with WON defined according to the revised Atlanta classification\n* The longest diameter of WON is 4 cm or larger\n* Patients with at least one out of the following conditions; signs of infection, gastrointestinal symptoms, abdominal symptoms, obstructive jaundice\n* Patients who need drainage for WON\n* Age of 18 years or older\n* Patients or their representatives provide informed consent\n* Patients who visit or are hospitalized at the participating institutions\n\nExclusion Criteria:\n\n* WON inaccessible by EUS-guided approach\n* AXIOS stent has already been placed into the WON prior to the enrollment\n* Severe coagulopathy; Platelet count \\\u003C 50,000\u002Fmm3 or prothrombin time international normalized ratio (PT-INR) \\>1.5\n* Patients on antithrombotic agents which cannot be managed according to the \"guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)\"\n* Patients who cannot tolerate endoscopic procedures\n* Pregnant women\n* Patients considered inappropriate for inclusion by investigators","ALL","18 Years",{"count":313,"type":314},70,"ESTIMATED","INTERVENTIONAL",[317],"NA","Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and\u002For additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.",[320,321,322,323],"Pancreatic Fluid Collection","Walled-off Necrosis","Pancreatitis, Acute Necrotizing","Pancreatic Pseudocyst",[325,326,327,328,15],"Endosonography","Drainage","Stents","Endoscopic necrosectomy","2022-10-26",{"date":331,"type":332},"2022-10-27","ACTUAL",{"date":334,"type":332},"2022-07-29",{"date":336,"type":314},"2031-04-11",{"name":5,"class":6},21]