[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatitis-acute-necrotizing\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatitis-acute-necrotizing":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100624212","strategic-timing-of-endoscopic-interventions-in-infected-necrotizing-pancreatitis-100624212",false,"NCT07406698","Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis","Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis: The STEP-IN Trial","STEP-IN","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients with symptomatic necrotic collection diagnosed on MRI or CT abdomen\u002Fpelvis, defined as fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall.\n3. Documented or suspected infected necrotizing pancreatitis 1) Documented infected necrotizing pancreatitis, defined as: i. Positive culture obtained with percutaneous fine needle aspiration from the pancreatic necrotic collection (if intervention is undertaken ≤14 days of onset of acute pancreatitis) ii. OR gas in the necrotic collection on imaging at any time. 2) Suspected infected necrotizing pancreatitis, if \\>14 days after onset of disease, defined as: i. Persistent organ failure in patients admitted to the ICU ii. OR presence of at least three of the following six clinical\u002Flaboratory parameters (SIRS criteria or elevated CRP or elevated procalcitonin) with no other infection focus. These clinical criteria are considered sufficiently reliable only after the initial 14 days of acute pancreatitis:\n\n   1. Temperature \\>100.4 °F or \\\u003C96.8 °F\n   2. Heart rate \\> 90 beats\u002Fmin\n   3. Respiratory rate \\>20 breaths\u002Fmin or PaCO2 \\\u003C 32 mmHg\n   4. WBC count \\>12,000\u002Fmm³, or \\\u003C4,000\u002Fmm³, or more than 10% immature band cells\n   5. CRP ≥ 30mg\u002FL\n   6. Procalcitonin ≥ 1ng\u002FmL\n4. Endoscopic drainage of the necrotic collection is technically feasible as deemed by the treating physician.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. \\> 26 days after the onset of acute pancreatitis\n3. Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome).\n4. Necrotic collection is not amenable for endoscopic intervention.\n5. Pregnancy.\n6. Unable to obtain informed consent from the patient or legally authorized representative.","ALL","18 Years",{"count":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"NA","Pancreatic necrosis complicates approximately 20-30% of severe acute pancreatitis cases. While many collections resolve without intervention, persistent symptomatic collections-particularly when infected-are associated with significant morbidity and mortality and frequently require procedural management. Current guidelines recommend delaying intervention until collections are fully walled off, typically around four weeks. However, in clinical practice, many patients deteriorate before this window is reached.\n\nProspective data from our institution, supported by recent meta-analyses, suggest that early intervention using modern endoscopic techniques can be performed safely, even when undertaken within the first four weeks of disease onset. We believe that, in appropriately selected patients, early endoscopic intervention may prevent clinical deterioration, reduce complications, shorten hospital stay, and decrease overall healthcare utilization compared with a delayed approach.\n\nTo formally evaluate this strategy, an international, multicenter randomized trial is being conducted, entitled Strategic Timing of Endoscopic Procedural Interventions in Infected Necrotizing Pancreatitis (STEP-IN Trial).",[27],"Pancreatitis, Acute Necrotizing",[29,30,31,32],"Endoscopic ultrasound","Drainage","Necrotic collection","Timing of intervention","RECRUITING","2026-02-09",{"date":36,"type":37},"2026-02-12","ACTUAL",{"date":39,"type":21},"2026-01-28",{"date":41,"type":21},"2029-12-31",{"name":43,"class":44},"Orlando Health, Inc.","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100601119","encapsulation-oriented-vs-timing-oriented-strategies-for-necrotizing-pancreatitis-100601119","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.",{"count":55,"type":21},224,[24],"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.",[59,60,61,62,27],"Walled Off Necrosis","Pancreatitis","Acute Necrotic Collection","Necrotizing Pancreatitis",[64,30,59,65,66],"Endosonography","necrotizing pancreatitis","pancreatitis","NOT_YET_RECRUITING","2025-07-30",{"date":70,"type":37},"2025-08-06",{"date":72,"type":21},"2025-08-05",{"date":74,"type":21},"2028-07-31",{"name":76,"class":44},"Tokyo University",36,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100473977","immediate-necrosectomy-vs-step-up-approach-for-walled-off-necrosis-100473977","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",{"count":87,"type":21},70,[24],"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.",[91,92,27,93],"Pancreatic Fluid Collection","Walled-off Necrosis","Pancreatic Pseudocyst",[64,30,95,96,97],"Stents","Endoscopic necrosectomy","Step-up approach","2022-10-26",{"date":100,"type":37},"2022-10-27",{"date":102,"type":37},"2022-07-29",{"date":104,"type":21},"2031-04-11",{"name":76,"class":44},21]