[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659397":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":40,"studyPopulation":41,"armGroups":42,"interventions":48,"overallOfficials":54,"centralContacts":59,"locations":69,"responsibleParty":219,"collaborators":36,"id":223,"slug":224,"hasResults":225,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":225,"sex":231,"minAge":232,"maxAge":36,"enrollmentInfo":233,"targetDuration":236,"studyType":237,"phases":36,"briefSummary":238,"conditions":239,"keywords":243,"overallStatus":72,"whyStopped":36,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},{"fullName":5,"class":6},"Tokyo University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Participants Achieving Clinical Success Within 180 Days","Clinical success is defined as resolution of the symptoms and clinical signs that required treatment, together with resolution or marked reduction of the target fluid collection on follow-up imaging. For infection-related cases, improvement in at least two of body temperature, white blood cell count, and C-reactive protein is required.","Within 180 days after enrollment",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Proportion of Participants With Technical Success of the Initial Intervention","Technical success is defined as successful completion of the intended endoscopic, percutaneous, or surgical procedure. This measure will be assessed only among participants who undergo an intervention.","On the day of the initial intervention (1 day per participant)",{"measure":19,"description":20,"timeFrame":12},"Procedure-Related Adverse Events","Proportion of participants experiencing an adverse event considered related to an endoscopic, percutaneous, or surgical procedure.",{"measure":22,"description":23,"timeFrame":12},"Need for Additional Intervention","Proportion of participants requiring an additional endoscopic, percutaneous, or surgical intervention for the index local complication.",{"measure":25,"description":26,"timeFrame":12},"Recurrence of the Target Fluid Collection","Proportion of participants with recurrence of a symptomatic target fluid collection requiring treatment after initial clinical success.",{"measure":28,"description":29,"timeFrame":12},"All-Cause Mortality","Proportion of participants who die from any cause.",{"measure":31,"description":32,"timeFrame":12},"Number of Interventions","Total number of endoscopic, percutaneous, and surgical interventions performed for the index local complication.",{"measure":34,"description":35,"timeFrame":12},"Total Duration of Hospitalization","Total number of inpatient days related to management of the index local complication.",null,{"allocation":36,"interventionModel":36,"interventionModelDescription":36,"primaryPurpose":36,"observationalModel":38,"timePerspective":39,"maskingInfo":36},"COHORT","PROSPECTIVE","Local complications of acute pancreatitis, including pancreatic and peripancreatic fluid collections, may require conservative management, endoscopic or percutaneous drainage, necrosectomy, or surgery. Similar fluid collections may occur after pancreatic surgery as a result of postoperative pancreatic fistula. Evidence regarding treatment selection, timing, and outcomes remains limited because individual centers encounter relatively few cases.\n\nThis prospective multicenter registry will collect clinical, laboratory, imaging, treatment, and outcome data generated during routine care. The primary objective is to evaluate clinical success within 180 days after enrollment. Secondary objectives include technical success, adverse events, additional interventions, recurrence, mortality, and healthcare utilization.\n\nExploratory analyses will evaluate patient, disease, imaging, and treatment factors associated with clinical outcomes. No diagnostic or therapeutic intervention is assigned by the study protocol.","Adults receiving routine inpatient or outpatient care at participating institutions for local complications of acute pancreatitis or postoperative pancreatic fistula.",[43],{"label":44,"type":36,"description":45,"interventionNames":46},"Patients With Local Complications of Acute Pancreatitis or Postoperative Pancreatic Fistula","Adults receiving routine clinical care for local complications of acute pancreatitis or postoperative pancreatic fistula. Management may include conservative care, endoscopic or percutaneous intervention, or surgery. No intervention is assigned by the study.",[47],"Procedure: Routine Clinical Management of Local Complications",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":36},"PROCEDURE","Routine Clinical Management of Local Complications","Participants receive routine clinical management selected by their treating clinicians. Management may include conservative treatment, endoscopic or percutaneous drainage, necrosectomy, stent placement, or surgery when clinically indicated. No diagnostic or therapeutic procedure is assigned by the study protocol.",[44],[55],{"name":56,"affiliation":57,"role":58},"Tomotaka Saito, MD, PhD","Graduate School of Medicine, The University of Tokyo","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":36,"email":64},"Yousuke Nakai, MD, PhD","CONTACT","+81-3-3353-8111","ynakai-tky@umin.ac.jp",{"name":56,"role":62,"phone":66,"phoneExt":67,"email":68},"+81-3-3815-5411","37199","tomsaito-gi@umin.ac.jp",[70,89,101,111,121,132,144,154,165,178,193,206],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Department of Gastroenterology, Shiga University of Medical Science","RECRUITING","Ōtsu","Shiga","520-2192","Japan","JP",{"type":79,"coordinates":80},"Point",[81,82],135.86667,35,{"lat":82,"lon":81},[85],{"name":86,"role":62,"phone":87,"phoneExt":36,"email":88},"Shuhei Shintani","+81-77-548-2111","s.shuhei513@gmail.com",{"facility":90,"status":72,"city":91,"state":92,"zip":36,"country":76,"countryCode":77,"cosmosGeoPoint":36,"geoPoint":36,"contacts":93},"Department of Gastroenterology, Graduate School of Medicine, Juntendo University","Bunkyō-Ku","Tokyo",[94,96,98],{"name":95,"role":62,"phone":36,"phoneExt":36,"email":36},"Hiroyuki Isayama",{"name":97,"role":62,"phone":36,"phoneExt":36,"email":36},"Toshio Fujisawa",{"name":99,"role":100,"phone":36,"phoneExt":36,"email":36},"Sho Takahashi","SUB_INVESTIGATOR",{"facility":102,"status":72,"city":92,"state":92,"zip":103,"country":76,"countryCode":77,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"The University of Tokyo Hospital","113-8655",{"type":79,"coordinates":105},[106,107],139.69171,35.6895,{"lat":107,"lon":106},[110],{"name":56,"role":62,"phone":66,"phoneExt":67,"email":68},{"facility":112,"status":72,"city":92,"state":92,"zip":113,"country":76,"countryCode":77,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"Department of Gastroenterology, Tokyo Women's Medical University","162-8666",{"type":79,"coordinates":115},[106,107],{"lat":107,"lon":106},[118],{"name":119,"role":62,"phone":63,"phoneExt":36,"email":120},"Ryunosuke Hakuta","ryuhakuta@gmail.com",{"facility":122,"status":72,"city":123,"state":36,"zip":36,"country":76,"countryCode":77,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Department of Gastroenterology, Gifu Municipal Hospital","Gifu",{"type":79,"coordinates":125},[126,127],136.76039,35.42291,{"lat":127,"lon":126},[130],{"name":131,"role":62,"phone":36,"phoneExt":36,"email":36},"Keisuke Iwata",{"facility":133,"status":72,"city":123,"state":36,"zip":36,"country":76,"countryCode":77,"cosmosGeoPoint":134,"geoPoint":136,"contacts":137},"Department of Gastroenterology, Gifu Prefectural General Medical Center",{"type":79,"coordinates":135},[126,127],{"lat":127,"lon":126},[138,141],{"name":139,"role":62,"phone":36,"phoneExt":36,"email":140},"Hironao Ichikawa","ichi.hiro.m.0814@gmail.com",{"name":142,"role":62,"phone":36,"phoneExt":36,"email":143},"Naoki Mita","mitanao8@yahoo.co.jp",{"facility":145,"status":72,"city":123,"state":36,"zip":36,"country":76,"countryCode":77,"cosmosGeoPoint":146,"geoPoint":148,"contacts":149},"First Department of Internal Medicine, Gifu University Hospital",{"type":79,"coordinates":147},[126,127],{"lat":127,"lon":126},[150,152],{"name":151,"role":62,"phone":36,"phoneExt":36,"email":36},"Shinya Uemura",{"name":153,"role":62,"phone":36,"phoneExt":36,"email":36},"Akinori Maruta",{"facility":155,"status":72,"city":156,"state":36,"zip":36,"country":76,"countryCode":77,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University","Hyōgo",{"type":79,"coordinates":158},[159,160],144.43333,43.36667,{"lat":160,"lon":159},[163],{"name":164,"role":62,"phone":36,"phoneExt":36,"email":36},"Hideyuki Shiomi",{"facility":166,"status":72,"city":167,"state":36,"zip":36,"country":76,"countryCode":77,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University","Kawagoe",{"type":79,"coordinates":169},[170,171],139.48528,35.90861,{"lat":171,"lon":170},[174,176],{"name":175,"role":62,"phone":36,"phoneExt":36,"email":36},"Saburo Matsubara",{"name":177,"role":62,"phone":36,"phoneExt":36,"email":36},"Keito Nakagawa",{"facility":179,"status":72,"city":180,"state":36,"zip":36,"country":76,"countryCode":77,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine","Kobe",{"type":79,"coordinates":182},[183,184],135.183,34.6913,{"lat":184,"lon":183},[187,189,191],{"name":188,"role":62,"phone":36,"phoneExt":36,"email":36},"Mitsuhiro Masuda",{"name":190,"role":62,"phone":36,"phoneExt":36,"email":36},"Atsuhiro Masuda",{"name":192,"role":100,"phone":36,"phoneExt":36,"email":36},"Masahiro Tsujimae",{"facility":194,"status":72,"city":195,"state":36,"zip":36,"country":76,"countryCode":77,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine","Ōsaka-sayama",{"type":79,"coordinates":197},[198,199],135.55069,34.49524,{"lat":199,"lon":198},[202,204],{"name":203,"role":62,"phone":36,"phoneExt":36,"email":36},"Mamoru Takenaka",{"name":205,"role":62,"phone":36,"phoneExt":36,"email":36},"Shunsuke Omoto",{"facility":207,"status":72,"city":208,"state":36,"zip":36,"country":76,"countryCode":77,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Third Department of Internal Medicine, University of Toyama","Toyama",{"type":79,"coordinates":210},[211,212],137.21667,36.7,{"lat":212,"lon":211},[215,217],{"name":216,"role":62,"phone":36,"phoneExt":36,"email":36},"Ichiro Yasuda",{"name":218,"role":62,"phone":36,"phoneExt":36,"email":36},"Nobuhiko Hayashi",{"type":58,"investigatorFullName":220,"investigatorTitle":221,"investigatorAffiliation":222,"oldNameTitle":36,"oldOrganization":36},"Yousuke Nakai","Professor","Tokyo Women's Medical University","100659397","management-and-outcomes-of-local-complications-of-acute-pancreatitis-and-postoperative-pancreatic-fistula-100659397",false,"NCT07862088","Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula","WONDERFUL Registry: A Multicenter Prospective Observational Study of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula","WONDERFUL","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosed with a local complication of acute pancreatitis, including acute exacerbation of chronic pancreatitis, or postoperative pancreatic fistula requiring routine clinical management.\n* Receiving inpatient or outpatient care at a participating institution.\n\nExclusion Criteria:\n\n* Considered unsuitable for participation by the treating investigator.\n* Declines participation through the opt-out process.","ALL","18 Years",{"count":234,"type":235},5000,"ESTIMATED","5 Years","OBSERVATIONAL","This multicenter prospective observational registry will evaluate the clinical characteristics and treatment outcomes of adults with local complications of acute pancreatitis or postoperative pancreatic fistula. Data generated during routine clinical care, including patient characteristics, imaging findings, treatments, adverse events, recurrence, and clinical outcomes, will be collected. Treatment is determined by the treating physicians and is not assigned by the study protocol.",[240,241,242],"Acute Pancreatitis","Pancreatic Fluid Collection","Postoperative Pancreatic Fistula",[244,245,246,247,248,249,250,251],"acute peripancreatic fluid collection","acute necrotic collection","walled-off necrosis","pancreatic pseudocyst","endoscopic drainage","percutaneous drainage","necrosectomy","postoperative pancreatic fistula","2026-10-01",{"date":254,"type":255},"2026-10-07","ACTUAL",{"date":257,"type":255},"2023-09-14",{"date":259,"type":235},"2028-07-31",{"name":5,"class":6},12]