[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616564":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":70,"collaborators":32,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":32,"enrollmentInfo":83,"targetDuration":32,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":51,"whyStopped":32,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Stent Replacement Arm (2-Week LAMS Removal + DPT Placement)","EXPERIMENTAL","Participants in this arm will undergo early removal of the lumen-apposing metal stent (LAMS) at 2 weeks after initial endoscopic drainage for walled-off pancreatic necrosis (WON). Following LAMS removal, a double-pigtail plastic stent (DPT) will be placed across the transmural tract to maintain drainage and reduce the risk of recurrent pancreatic fluid collection (PFC). Patients will undergo follow-up imaging at 3, 6, and 12 months to assess recurrence, complications, and need for reintervention.",[13],"Procedure: Standard LAMS Removal with Double-Pigtail Plastic Stent",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Stent Replacement Arm (4-Week LAMS Removal without DPT)","ACTIVE_COMPARATOR","Participants in this arm will undergo standard removal of the LAMS at 4 weeks after initial endoscopic drainage for walled-off pancreatic necrosis (WON). Patients will be followed at 3, 6, and 12 months to assess recurrence of pancreatic fluid collection (PFC), complications, and reintervention rates.",[19],"Procedure: Standard LAMS Removal without DPT",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Standard LAMS Removal with Double-Pigtail Plastic Stent","In the early stent removal arm, LAMS will be removed at 2 weeks followed by placement of a double-pigtail plastic stent (DPT).",[9],[27],"EARLY",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standard LAMS Removal without DPT","In the standard arm, LAMS will be removed at 4 weeks.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Deepak L Jha, (Medical Gastroenterology)","Asian Institute of Gastroenterology, Hyderabad","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Deepak L JHA, DrNB( medical gastroenterology","CONTACT","91-9967807858","drd55pakjha@gmail.com",{"name":45,"role":41,"phone":46,"phoneExt":32,"email":47},"Nitin G Jagtap, DNB (Medical Gastroenterology)","+91-82859523","docnits13@gmail.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Asian Institute of Gastroenterology","RECRUITING","Hyderabad","Telangana","500082","India","IN",{"type":58,"coordinates":59},"Point",[60,61],78.45636,17.38405,{"lat":61,"lon":60},[64,67],{"name":65,"role":41,"phone":66,"phoneExt":32,"email":43},"Deepak L JHA, Medical Gastroenterology","+91 9967807858",{"name":68,"role":41,"phone":69,"phoneExt":32,"email":47},"Nitin G Jagtap, Medical Gastroenterology)","+91 82859523",{"type":37,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Mohan Ramchandani","DIRECTOR , INTERVENTIONAL ENDOSCOPY","100616564","to-evaluate-early-2-week-vs-standard-4-week-metal-stent-removal-following-endoscopic-ultrasound-guided-won-drainage-100616564",false,"NCT07307248","To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage","A Randomized Controlled Trial To Evaluate Early (2-Week) vs. Standard (4-Week) Metal Stent Removal Following Endoscopic Ultrasound Guided WON Drainage.","STEP1","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients with walled-off pancreatic necrosis (WON) undergoing endoscopic ultrasound-guided drainage with lumen-apposing metal stent (LAMS)\n* Radiological resolution of the pancreatic fluid collection ≥70% at 2 weeks after index endoscopic drainage, assessed on cross-sectional imaging (CT or MRI)\n\nExclusion Criteria:\n\n* Presence of chronic pancreatitis\n* Pancreatic malignancy (suspected or confirmed)\n* Incomplete endoscopic necrosectomy or persistent large necrotic debris on imaging at 2 weeks after drainage\n* Occurrence of major procedure-related adverse events within the first 2 weeks, including:\n* Clinically significant bleeding\n* Infection requiring additional intervention\n* Stent migration\n* Inability or unwillingness to provide written informed consent","ALL","18 Years",{"count":84,"type":85},408,"ESTIMATED","INTERVENTIONAL",[88],"NA","In adults with walled-off pancreatic necrosis (WON) undergoing endoscopic ultrasound (EUS)-guided transluminal necrosectomy, does early removal of the lumen-apposing metal stent (LAMS) (at 2 weeks or immediately after the last necrosectomy) with placement of a double-pigtail plastic stent (DPT), compared to delayed LAMS removal at 4 weeks without a DPT, result in a lower rate of pancreatic fluid collection (PFC) recurrence or need for reintervention over 12 months.",[91],"Walled Off Necrosis",[93],"Early LAMS removal","2026-01-27",{"date":96,"type":97},"2026-01-28","ACTUAL",{"date":99,"type":97},"2025-12-25",{"date":101,"type":85},"2028-12-31",{"name":5,"class":6},1]