[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458690":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":157,"collaborators":25,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":25,"eligibilityCriteria":167,"healthyVolunteers":163,"sex":168,"minAge":169,"maxAge":25,"enrollmentInfo":170,"targetDuration":25,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic step-up approach","ACTIVE_COMPARATOR","After endoscopic drainage of WON, patients will be reassessed 72 hours after the procedure. If there is no clinical improvement 72 hours after drain placement, a CECT is performed to check the adequacy of the drainage. Irrigation of the WON via a nasocystic drain or endoscopic irrigation (step 1) is performed in case of inadequate drainage. If a nasocystic drain is inserted, 500ml of normal saline, twice a day will be used to irrigate the WON. If endoscopic irrigation is performed, only irrigation with normal saline without necrosectomy is allowed.\n\nPatients are again evaluated 72 hours after step 1. In case of improvement, treatment is conservative; otherwise step 2 will be initiated, which is endoscopic necrosectomy. Further endoscopic necrosectomy will be performed until there is clinical improvement.",[13],"Procedure: Endoscopic necrosectomy with step up approach",{"label":15,"type":10,"description":16,"interventionNames":17},"Direct endoscopic necrosectomy approach","Patients in the DEN group will undergo an immediate endoscopic necrosectomy after LAMS placement and balloon dilatation. A 10Fr 5cm double pigtail plastic stent will be inserted within the LAMS after necrosectomy. Patients will be assessed in 72 hours after the procedure. If there is no clinical improvement, a CECT is performed to check the adequacy of the drainage. DEN will be repeated in case of inadequate drainage. Patients will be reassessed every 72 hours and DEN repeated until there is clinical improvement. Subsequently, necrosectomy is performed weekly until a reassessment CECT at 3 weeks.",[18],"Procedure: Endoscopic necrosectomy with direct approach",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Endoscopic necrosectomy with step up approach","Endoscopic necrosectomy will be performed with a forward-viewing gastroscope into the WON cavity. Debridement of necrotic tissue will be performed with irrigation and\u002For mechanical removal with endoscopic instruments. For this arm, step up approach will be adopted.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Endoscopic necrosectomy with direct approach","Endoscopic necrosectomy will be performed with a forward-viewing gastroscope into the WON cavity. Debridement of necrotic tissue will be performed with irrigation and\u002For mechanical removal with endoscopic instruments. For this arm, the direct approach will be adopted.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Shannon Chan","CONTACT","852-35052627","shannonchan@surgery.cuhk.edu.hk",{"name":37,"role":33,"phone":34,"phoneExt":25,"email":38},"Anthony Teoh","anthonyteoh@surgery.cuhk.edu.hk",[40,56,69,83,95,107,120,129,143],{"facility":41,"status":42,"city":43,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Royal Adelaide Hospital","RECRUITING","Adelaide","Australia","AU",{"type":47,"coordinates":48},"Point",[49,50],138.59863,-34.92866,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":25,"phoneExt":25,"email":55},"Nam Nguyen","QuocNam.Nguyen@sa.gov.au",{"facility":57,"status":42,"city":58,"state":25,"zip":59,"country":58,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"The Chinese University of Hong Kong","Hong Kong","0000","HK",{"type":47,"coordinates":62},[63,64],114.17469,22.27832,{"lat":64,"lon":63},[67],{"name":32,"role":33,"phone":68,"phoneExt":25,"email":35},"35052627",{"facility":70,"status":42,"city":71,"state":25,"zip":25,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Medanta Institute Of Digestive & Hepatobiliary Sciences","Haryāna","India","IN",{"type":47,"coordinates":75},[76,77],76.98056,29.61611,{"lat":77,"lon":76},[80],{"name":81,"role":33,"phone":25,"phoneExt":25,"email":82},"Rajesh Puri","purirajesh1969@gmail.com",{"facility":84,"status":42,"city":85,"state":25,"zip":25,"country":72,"countryCode":73,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Asian Institute of Gastroenterology","Hyderabad",{"type":47,"coordinates":87},[88,89],78.45636,17.38405,{"lat":89,"lon":88},[92],{"name":93,"role":33,"phone":25,"phoneExt":25,"email":94},"Sundeep Lakhtakia","drsundeeplakhtakia@gmail.com",{"facility":96,"status":42,"city":97,"state":25,"zip":25,"country":72,"countryCode":73,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Deenanath Mangeshkar Hospital & Research Centre","Pune",{"type":47,"coordinates":99},[100,101],73.85535,18.51957,{"lat":101,"lon":100},[104],{"name":105,"role":33,"phone":25,"phoneExt":25,"email":106},"Amol Bapaye","amolbapaye@gmail.com",{"facility":108,"status":42,"city":109,"state":25,"zip":25,"country":110,"countryCode":25,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Asan Medical Centre","Asan","South Korea",{"type":47,"coordinates":112},[113,114],127.00417,36.78361,{"lat":114,"lon":113},[117],{"name":118,"role":33,"phone":25,"phoneExt":25,"email":119},"Tae Jun Song","drsong@amc.seoul.kr",{"facility":121,"status":42,"city":109,"state":25,"zip":25,"country":110,"countryCode":25,"cosmosGeoPoint":122,"geoPoint":124,"contacts":125},"SoonChunHyang University School of Medicine",{"type":47,"coordinates":123},[113,114],{"lat":114,"lon":113},[126],{"name":127,"role":33,"phone":25,"phoneExt":25,"email":128},"Jong Ho Moon","jhmoonsch@gmail.com",{"facility":130,"status":42,"city":131,"state":25,"zip":25,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Hospital Universitario Rio Hortega","Valladolid","Spain","ES",{"type":47,"coordinates":135},[136,137],-4.72353,41.65541,{"lat":137,"lon":136},[140],{"name":141,"role":33,"phone":25,"phoneExt":25,"email":142},"Manuel Pérez-Miranda","mpmiranda5@hotmail.com",{"facility":144,"status":42,"city":145,"state":25,"zip":25,"country":146,"countryCode":147,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"King Chulalongkorn Memorial Hospital","Bangkok","Thailand","TH",{"type":47,"coordinates":149},[150,151],100.50144,13.75398,{"lat":151,"lon":150},[154],{"name":155,"role":33,"phone":25,"phoneExt":25,"email":156},"Pradermchai Kongkam","kongkam@hotmail.com",{"type":158,"investigatorFullName":159,"investigatorTitle":160,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","CHAN SHANNON MELISSA","Assistant Professor","100458690","timing-of-necrosectomy-after-endoscopic-drainage-of-walled-off-pancreatic-necrosis-won-100458690",false,"NCT05252897","Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)","Direct Endoscopic Necrosectomy Versus Endoscopic Step-up Approach After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)","Inclusion Criteria:\n\n1. Adult (≥18 years of age) patients\n2. Diagnosis of walled-off pancreatic necrosis (WON) based on imaging criteria based on the revised Atlanta classification5\n3. Documented history of acute pancreatitis\n4. Suspected or confirmed infected WON and\u002For symptomatic WON causing (i) persistent pancreatic-type pain, and\u002For ii) gastric outlet or biliary obstruction, and\u002For (iii) ongoing systemic illness, anorexia, and weight loss, and\u002For (iv) rapidly enlarging WONs, and\u002For (v) infected WON\\*\n5. WON identified at contrast-enhanced computed tomography (CECT) and deemed amenable for EUS-guided drainage\n6. WON with a solid component \\>30% and\u002F or percentage of necrosis \\>= 30%\n\nExclusion Criteria:\n\n1. Previous invasive interventions for necrotising pancreatitis\n2. An acute flare up of chronic pancreatitis\n3. Recurrent acute pancreatitis\n4. Indicated for emergency laparotomy (i.e. abdominal compartment syndrome, perforation of a visceral organ, bleeding and bowel ischaemia)\n5. Contraindications to endoscopic drainage: previous total gastrectomy, gastric bypass surgery, prior surgery for pancreas-related diseases\n6. WON not adherent to the GI wall or not accessible for endoscopic drainage\n7. Coagulopathy (INR \\>1.5), and\u002For thrombocytopenia (platelets \\\u003C50,000\u002Fmm3)\n8. Pregnancy","ALL","18 Years",{"count":171,"type":172},108,"ESTIMATED","INTERVENTIONAL",[175],"NA","Walled-off pancreatic necrosis (WON) is associated with a mortality of 20-30%. The current evidence supports a minimally invasive drainage approach to infected WON. The current suggested approach in international guidelines is the endoscopic step-up approach. However, recent evidence from large national cohorts support the use of direct endoscopic necrosectomy (DEN) at the time of stent placement, resulting in earlier resolution of WON and less number of necrosectomies. This study aims to investigate the clinical outcomes of the DEN versus the step-up approach for necrosectomy after endoscopic drainage of WON.",[178],"Pancreatic Necrosis",[180,181,182,183],"walled off pancreatic necrosis","endoscopic drainage","direct endoscopic necrosectomy","endoscopic step up approach","2022-02-22",{"date":186,"type":187},"2022-03-09","ACTUAL",{"date":189,"type":187},"2022-02-01",{"date":191,"type":172},"2026-06-30",{"name":5,"class":6},9]