[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601119":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":265,"collaborators":268,"id":270,"slug":271,"hasResults":272,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":272,"sex":278,"minAge":279,"maxAge":25,"enrollmentInfo":280,"targetDuration":25,"studyType":283,"phases":284,"briefSummary":286,"conditions":287,"keywords":293,"overallStatus":298,"whyStopped":25,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},{"fullName":5,"class":6},"Tokyo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Encapsulation-Oriented Group","EXPERIMENTAL","The timing of endoscopic intervention for necrotizing pancreatitis is determined based on the degree of encapsulation",[13],"Procedure: The timing of endoscopic intervention for necrotizing pancreatitis is determined based on the degree of encapsulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Timing-Oriented Group","ACTIVE_COMPARATOR","EUS-guided drainage based on the interval from the onset of acute pancreatitis",[19],"Procedure: EUS-guided drainage based on the interval from the onset of acute pancreatitis",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","In the encapsulation-oriented group, participants undergo EUS-guided drainage of necrotizing pancreatitis when the degree of encapsulation reaches ≥80%, as confirmed by cross-sectional imaging (preferably contrast-enhanced CT). Imaging is repeated every 7-10 days after enrollment to assess encapsulation. Once sufficient encapsulation is observed and the patient presents with symptoms such as infection, abdominal pain, GOO or biliary obstruction, endoscopic drainage is performed. Drainage is typically performed using a lumen-apposing metal stent (LAMS) placed under EUS guidance, often accompanied by placement of an external drain. Step-up therapy, including endoscopic necrosectomy or additional drainage procedures, may be used if symptoms do not improve. If the patient improves with conservative therapy before encapsulation is achieved, drainage may be deferred. Endoscopic\u002Fpercutaneous interventions should, in principle, be discussed with the expert panel beforehand.",[9],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"In the timing-oriented group, participants undergo EUS-guided drainage of necrotizing pancreatitis at 4 to 5 weeks after the onset of acute pancreatitis, regardless of the degree of encapsulation. Drainage is performed only in symptomatic patients who meet predefined clinical criteria, such as signs of infection, significant pain, GOO, or biliary obstruction. Imaging is performed before the procedure. The standard approach involves placing a LAMS under EUS guidance, optionally supplemented by external drains. If symptoms do not improve, step-up interventions such as endoscopic necrosectomy, percutaneous drainage may be considered. If inflammation and symptoms improve with conservative treatment (e.g., antibiotics), EUS-guided drainage may be omitted. Conversely, even before 4-5 weeks from onset, early drainage is allowed if conservative treatment is deemed insufficient by the attending physician. In principle, intervention decisions should be discussed with the expert panel.",[15],[30],{"name":31,"affiliation":32,"role":33},"Yousuke Nakai","Department of Gastroenterology, Tokyo Women's Medical University","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+81-3-3353-8111","ynakai-tky@umin.ac.jp",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Tomotaka Saito","+81-3-3815-5411","tomsaito-gi@umin.ac.jp",[44,55,63,71,79,84,89,92,100,108,116,124,132,140,148,156,164,172,180,185,190,198,205,210,218,220,222,229,234,236,238,240,243,245,247,255],{"facility":45,"status":25,"city":46,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":25},"Department of Gastroenterology, Aichi Medical University","Aichi","Japan","JP",{"type":50,"coordinates":51},"Point",[52,53],130.62158,32.51879,{"lat":53,"lon":52},{"facility":56,"status":25,"city":57,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":58,"geoPoint":62,"contacts":25},"Department of Gastroenterology, Graduate School of Medicine, Chiba University","Chiba",{"type":50,"coordinates":59},[60,61],140.11667,35.6,{"lat":61,"lon":60},{"facility":64,"status":25,"city":65,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":66,"geoPoint":70,"contacts":25},"Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University","Fukuoka",{"type":50,"coordinates":67},[68,69],130.41667,33.6,{"lat":69,"lon":68},{"facility":72,"status":25,"city":73,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":74,"geoPoint":78,"contacts":25},"Department of Gastroenterology, Gifu Municipal Hospital","Gifu",{"type":50,"coordinates":75},[76,77],136.76039,35.42291,{"lat":77,"lon":76},{"facility":80,"status":25,"city":73,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":81,"geoPoint":83,"contacts":25},"Department of Gastroenterology, Gifu Prefectural General Medical Center",{"type":50,"coordinates":82},[76,77],{"lat":77,"lon":76},{"facility":85,"status":25,"city":73,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":86,"geoPoint":88,"contacts":25},"First Department of Internal Medicine, Gifu University Hospital",{"type":50,"coordinates":87},[76,77],{"lat":77,"lon":76},{"facility":90,"status":25,"city":91,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Department of Gastroenterology and Hepatology, Hokkaido University Hospital","Hokkaido",{"facility":93,"status":25,"city":94,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":95,"geoPoint":99,"contacts":25},"Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo MedicalUniversity","Hyōgo",{"type":50,"coordinates":96},[97,98],144.43333,43.36667,{"lat":98,"lon":97},{"facility":101,"status":25,"city":102,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":103,"geoPoint":107,"contacts":25},"Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University","Kagawa",{"type":50,"coordinates":104},[105,106],131.03333,34.06667,{"lat":106,"lon":105},{"facility":109,"status":25,"city":110,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":111,"geoPoint":115,"contacts":25},"Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences","Kagoshima",{"type":50,"coordinates":112},[113,114],130.55,31.56667,{"lat":114,"lon":113},{"facility":117,"status":25,"city":118,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":119,"geoPoint":123,"contacts":25},"Department of Gastroenterology, Kameda Medical Center","Kamogawa",{"type":50,"coordinates":120},[121,122],140.1003,35.0969,{"lat":122,"lon":121},{"facility":125,"status":25,"city":126,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":127,"geoPoint":131,"contacts":25},"Department of Gastroenterology, St. Marianna University School of Medicine","Kanagawa",{"type":50,"coordinates":128},[129,130],139.91667,37.58333,{"lat":130,"lon":129},{"facility":133,"status":25,"city":134,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":135,"geoPoint":139,"contacts":25},"Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University","Kawagoe",{"type":50,"coordinates":136},[137,138],139.48528,35.90861,{"lat":138,"lon":137},{"facility":141,"status":25,"city":142,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":143,"geoPoint":147,"contacts":25},"Department of Gastroenterology, Teikyo University Mizonokuchi Hospital","Kawasaki",{"type":50,"coordinates":144},[145,146],139.71722,35.52056,{"lat":146,"lon":145},{"facility":149,"status":25,"city":150,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":151,"geoPoint":155,"contacts":25},"Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School ofMedicine","Kobe",{"type":50,"coordinates":152},[153,154],135.183,34.6913,{"lat":154,"lon":153},{"facility":157,"status":25,"city":158,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":159,"geoPoint":163,"contacts":25},"Department of Gastroenterology and Hepatology, Mie University Hospital","Mie",{"type":50,"coordinates":160},[161,162],131.58333,32.96667,{"lat":162,"lon":161},{"facility":165,"status":25,"city":166,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":167,"geoPoint":171,"contacts":25},"Department of Gastroenterology and Hepatology, Okayama University Hospital","Okayama",{"type":50,"coordinates":168},[169,170],133.93333,34.65,{"lat":170,"lon":169},{"facility":173,"status":25,"city":174,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":175,"geoPoint":179,"contacts":25},"2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University","Osaka",{"type":50,"coordinates":176},[177,178],135.50107,34.69379,{"lat":178,"lon":177},{"facility":181,"status":25,"city":174,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":182,"geoPoint":184,"contacts":25},"Department of Gastroenterology and Hepatology, Kansai Medical University Medical Center",{"type":50,"coordinates":183},[177,178],{"lat":178,"lon":177},{"facility":186,"status":25,"city":174,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":187,"geoPoint":189,"contacts":25},"Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine",{"type":50,"coordinates":188},[177,178],{"lat":178,"lon":177},{"facility":191,"status":25,"city":192,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":193,"geoPoint":197,"contacts":25},"Department of Gastroenterology, Shiga University of Medical Science","Shiga",{"type":50,"coordinates":194},[195,196],138.13005,36.02247,{"lat":196,"lon":195},{"facility":32,"status":25,"city":199,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":200,"geoPoint":204,"contacts":25},"Tokyo",{"type":50,"coordinates":201},[202,203],139.69171,35.6895,{"lat":203,"lon":202},{"facility":206,"status":25,"city":199,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":207,"geoPoint":209,"contacts":25},"Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine",{"type":50,"coordinates":208},[202,203],{"lat":203,"lon":202},{"facility":211,"status":25,"city":212,"state":47,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":213,"geoPoint":217,"contacts":25},"Department of Gastroenterology, Wakayama Medical University School of Medicine","Wakayama",{"type":50,"coordinates":214},[215,216],135.16667,34.23333,{"lat":216,"lon":215},{"facility":219,"status":25,"city":46,"state":199,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences",{"facility":221,"status":25,"city":46,"state":199,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Department of Gastroenterology, Nagoya University",{"facility":223,"status":25,"city":224,"state":199,"zip":225,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":226},"Department of Gastroenterology, The University of Tokyo Hospital","Bunkyō-Ku","113-8655",[227],{"name":228,"role":36,"phone":25,"phoneExt":25,"email":25},"Department of Gastroenterology, The University of Tokyo Hospit",{"facility":230,"status":25,"city":224,"state":199,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":231},"Department of Gastroenterology, Graduate School of Medicine, Juntendo University",[232],{"name":233,"role":36,"phone":25,"phoneExt":25,"email":25},"Department of Gastroenterology, Graduate School of Medicine, J",{"facility":235,"status":25,"city":65,"state":199,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Department of Gastroenterology, Fukuoka University",{"facility":237,"status":25,"city":65,"state":199,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Department of Gastroenterology, Kurume University",{"facility":239,"status":25,"city":73,"state":199,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Department of Gastroenterology, Matsunami General Hospital",{"facility":241,"status":25,"city":242,"state":199,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Department of Gastroenterology, Hiroshima University","Hiroshima",{"facility":244,"status":25,"city":242,"state":199,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Department of Gastroenterology, JA Onomichi General Hospital",{"facility":246,"status":25,"city":126,"state":199,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Gastroenterology Center, Yokohama City University Medical Center",{"facility":248,"status":25,"city":249,"state":199,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":250,"geoPoint":254,"contacts":25},"Department of Gastrointestinal, Hepatobiliary and Pancreatic Diseases, Sendai City Medical Center (Sendai Open Hospital)","Miyagi",{"type":50,"coordinates":251},[252,253],139.75421,35.75882,{"lat":253,"lon":252},{"facility":256,"status":25,"city":257,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"Third Department of Internal Medicine, University of Toyama","Toyama",{"type":50,"coordinates":259},[260,261],137.21667,36.7,{"lat":261,"lon":260},[264],{"name":256,"role":36,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":31,"investigatorTitle":266,"investigatorAffiliation":267,"oldNameTitle":25,"oldOrganization":25},"Professor, Department of Gastroenterology, Tokyo Women's Medical University","Tokyo Women's Medical University",[269],{"name":267,"class":6},"100601119","encapsulation-oriented-vs-timing-oriented-strategies-for-necrotizing-pancreatitis-100601119",false,"NCT07106346","Encapsulation-oriented vs. Timing-oriented Strategies for Necrotizing Pancreatitis","Encapsulation-oriented Versus Timing-oriented Strategies for the Timing of Endoscopic Ultrasound-guided Drainage in Necrotizing Pancreatitis After Acute Pancreatitis: A Multicenter Randomized Controlled Trial (WONDER-03)","WONDER-03","Inclusion Criteria:\n\n* Patients diagnosed with necrotizing pancreatitis according to the revised Atlanta classification, confirmed by contrast-enhanced CT (plain CT or MRI may be substituted if contrast-enhanced CT is not feasible).\n* Within 28 days of onset of acute pancreatitis.\n* Age ≥ 18 years at the time of consent, regardless of sex.\n* Provided written informed consent from the patient or a legally authorized representative after sufficient explanation.\n* Patients who are either hospitalized or being followed as outpatients at participating study institutions.\n\nExclusion Criteria:\n\n* Unknown date of onset of acute pancreatitis.\n* Patients who have already undergone transluminal drainage with stent placement for necrotizing pancreatitis.\n* Diagnosis of chronic pancreatitis.\n* Patients for whom endoscopic treatment is deemed unsafe.\n* Pregnant women.\n* Patients deemed inappropriate for the study by the principal investigator or sub-investigator.","ALL","18 Years",{"count":281,"type":282},224,"ESTIMATED","INTERVENTIONAL",[285],"NA","This multicenter, randomized controlled trial (WONDER-03 study) investigates the optimal timing for endoscopic ultrasound (EUS)-guided drainage in patients with necrotizing pancreatitis. Although current guidelines recommend delaying drainage until at least four weeks after the onset of acute pancreatitis to allow for encapsulation of necrosis, recent observational data suggest that the degree of encapsulation itself may more strongly influence treatment success and safety. In this trial, patients are randomly assigned to one of two groups: an encapsulation-oriented group, in which EUS-guided drainage is performed when imaging confirms ≥80% encapsulation of the necrotic collection with symptoms, and a timing-oriented group, in which drainage is performed at four to five weeks after disease onset, regardless of encapsulation status. The primary endpoint is clinical success within 180 days, defined as both radiologic resolution of necrosis and improvement in symptoms. Secondary endpoints include adverse event rates, recurrence of fluid collections, technical and clinical success rates, and healthcare resource use. This study aims to determine whether a strategy based on encapsulation leads to better clinical outcomes than the conventional time-based approach and may help establish a new evidence-based treatment algorithm for necrotizing pancreatitis.",[288,289,290,291,292],"Walled Off Necrosis","Pancreatitis","Acute Necrotic Collection","Necrotizing Pancreatitis","Pancreatitis, Acute Necrotizing",[294,295,288,296,297],"Endosonography","Drainage","necrotizing pancreatitis","pancreatitis","NOT_YET_RECRUITING","2025-07-30",{"date":301,"type":302},"2025-08-06","ACTUAL",{"date":304,"type":282},"2025-08-05",{"date":306,"type":282},"2028-07-31",{"name":5,"class":6},36]