[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616564":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":69,"collaborators":32,"id":72,"slug":32,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":32,"enrollmentInfo":81,"targetDuration":32,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":51,"whyStopped":32,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"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,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Asian Institute of Gastroenterology","RECRUITING","Hyderabad","Telangana","500082","India",{"type":57,"coordinates":58},"Point",[59,60],78.45636,17.38405,{"lat":60,"lon":59},[63,66],{"name":64,"role":41,"phone":65,"phoneExt":32,"email":43},"Deepak L JHA, Medical Gastroenterology","+91 9967807858",{"name":67,"role":41,"phone":68,"phoneExt":32,"email":47},"Nitin G Jagtap, Medical Gastroenterology)","+91 82859523",{"type":37,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Mohan Ramchandani","DIRECTOR , INTERVENTIONAL ENDOSCOPY","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":82,"type":83},408,"ESTIMATED","INTERVENTIONAL",[86],"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.",[89],"Walled Off Necrosis",[91],"Early LAMS removal","2026-01-27",{"date":94,"type":95},"2026-01-28","ACTUAL",{"date":97,"type":95},"2025-12-25",{"date":99,"type":83},"2028-12-31",{"name":5,"class":6},1]