[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604900":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":64,"id":65,"slug":64,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":64,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":90,"overallStatus":47,"whyStopped":64,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Minia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)","EXPERIMENTAL","Patients undergo standard duct-to-mucosa pancreaticojejunostomy with topical application of 1-2 mL modified N-butyl-2-cyanoacrylate to the anastomotic site and surrounding pancreatic parenchyma.",[13],"Drug: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Pancreaticojejunostomy without tissue adhesive application.","ACTIVE_COMPARATOR","Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy.",[19],"Procedure: Standard(duct-to-mucosa) Pancreaticojejunostomy",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","* Standard duct-to-mucosa pancreaticojejunostomy performed\n* Application of 0.5-1.0 mL modified N-butyl-2-cyanoacrylate around the anastomotic site\n* Adhesive applied circumferentially around the pancreaticojejunal anastomosis\n* Allow 2-3 minutes for polymerization before proceeding\n* Standard placement of peritoneal drains",[9],[26],"Tissue Adhesive, Cyanoacrylate Glue,Glubran® 2",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Standard(duct-to-mucosa) Pancreaticojejunostomy","* Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy.\n* Standard placement of peritoneal drains\n* All other aspects of surgical care identical to experimental arm",[15],[33],"Standard Pancreaticojejunostomy",[35],{"name":36,"affiliation":5,"role":37},"Saleh K Saleh, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+201201765401","+2","salehkhairy@mu.edu.eg",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Liver and GIT hospital , Minia University","RECRUITING","Minya","Minya Governorate","61519","Egypt","EG",{"type":54,"coordinates":55},"Point",[56,57],30.75813,28.09193,{"lat":57,"lon":56},[60],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},{"type":37,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"Saleh Khairy Saleh MD","Lecturer",null,"100604900",false,"NCT07155525","Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas","Pancreaticojejunostomy With or Without Modified N-butyl-2-cyanoacrylate Following Pancreaticoduodenectomy in Soft Pancreas: Randomized Controlled Trial","NBCA-MS","Inclusion Criteria:\n\n* Patients scheduled for elective pancreaticoduodenectomy for malignant lesions.\n* Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).\n* Age 18-75 years .\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Adequate organ function defined as:\n\nHemoglobin ≥ 9.0 g\u002FdL Absolute neutrophil count ≥ 1,500\u002FμL Platelet count ≥ 100,000\u002FμL Total bilirubin ≤ 3 times upper limit of normal Alanine transaminase (ALT) \u002FAlanine transaminase (ALT)( ≤ 5 times upper limit of normal Serum creatinine ≤ 1.5 times upper limit of normal\n\n* Informed consent provided.\n* Willingness to comply with study procedures and follow-up requirements.\n\nExclusion Criteria:\n\n* Hard pancreatic texture (intraoperative surgeon assessment).\n* Emergency surgery.\n* Previous pancreatic surgery or pancreatic anastomosis.\n* Intraoperative identification of unresectable disease\n* Known allergy to cyanoacrylate or components.\n* Pregnancy or lactation.\n* Active infection or sepsis.\n* Inability to comply with follow-up.","ALL","18 Years","75 Years",{"count":76,"type":77},194,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with soft pancreatic texture. The primary endpoint is the incidence of postoperative pancreatic fistula at 30 days post-surgery, as defined by the International Study Group on Pancreatic Fistula (ISGPF) criteria.Secondary outcomes include surgical complications and length of hospital stay. The study will enroll approximately 194 patients at a single center.",[83,84,85,86,87,88,89],"Pancreatic Cancer","Periampullary Cancer","Duodenal Cancer","Cholangiocarcinoma","Pancreatic Ductal Adenocarcinoma","Pancreatic Head Mass","Bile Duct Cancer",[91,92,93,94,95,96,97,98],"Pancreaticoduodenectomy","Pancreaticojejunostomy","Postoperative Pancreatic Fistula","Soft Pancreas","N-Butyl-2-Cyanoacrylate","Whipple procedure","Tissue adhesive","POPF prevention","2025-09-14",{"date":101,"type":102},"2025-09-18","ACTUAL",{"date":104,"type":102},"2025-09-15",{"date":106,"type":77},"2028-11-15",{"name":5,"class":6},1]