[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610663":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":60,"collaborators":63,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":27,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":63,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":46,"whyStopped":63,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Minia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group.","EXPERIMENTAL","Patients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy with pancreatic parenchymal injection of N-butyl-2-cyanoacrylate during pancreaticoduodenectomy.",[13],"Drug: Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group.",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Pancreaticojejunostomy","ACTIVE_COMPARATOR","Patients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy using the standard surgical technique of the institution, without the application of N-Butyl-2-Cyanoacrylate or any other sealant to the pancreatic anastomosis. No placebo injection will be administered.",[19],"Procedure: Standard Pancreaticojejunostomy",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group.","This procedure is integrated into the standard pancreaticoduodenectomy. Injection of Histoacryl® (n-butyl-2-cyanoacrylate) mixed with Lipiodol® (1:1 ratio) into the pancreatic parenchyma circumferentially (3, 6, 9, and 12 o'clock positions) around the main pancreatic duct (MPD) orifice, extending 5-8 mm deep and 5-10 mm laterally from the future anastomotic line, avoiding the main pancreatic duct and vessels. Total volume injected typically ranges from 0.2 ml to 0.6 ml. Follow with standard duct-to-mucosa pancreaticojejunostomy:\n\n* Tying down the posterior duct-to-mucosa sutures.\n* Placing and tying the anterior duct-to-mucosa sutures.\n* Tying down the posterior outer layer sutures.\n* Placing the anterior outer layer sutures. Meticulously avoid glue contact with sutures\u002Fmucosa Reconstruction: Complete the hepaticojejunostomy and duodenojejunostomy (or gastrojejunostomy).",[9],[27],"NBCA",{"type":29,"name":15,"description":17,"armGroupLabels":30,"otherNames":31},"PROCEDURE",[15],[32],"Standard PJ",[34],{"name":35,"affiliation":5,"role":36},"Saleh K Saleh, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","01201765401","+2","salehkhairy@mu.edu.eg",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Liver and GIT hospital , Minia University","RECRUITING","Minya","Minya Governorate","61519","Egypt","EG",{"type":53,"coordinates":54},"Point",[55,56],30.75813,28.09193,{"lat":56,"lon":55},[59],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},{"type":36,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"Saleh Khairy Saleh MD","Lecturer",null,"100610663","phase-2-pancreatic-parenchymal-injection-of-n-butyl-2-cyanoacrylate-100610663",false,"NCT07230509","Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate","Efficacy of Pancreatic Parenchymal N-Butyl-2-Cyanoacrylate Injection in Pancreaticojejunostomy After Pancreaticoduodenectomy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients undergoing pancreaticoduodenectomy for malignant lesions meeting the curative treatment intent in accordance with clinical guidelines.\n* Soft pancreatic texture.\n* Small main pancreatic duct diameter (\\\u003C3 mm).\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Known hypersensitivity to cyanoacrylate or Lipiodol®.\n* Extremely hard, fibrotic pancreas.\n* Significant pancreatitis involving the pancreatic remnant.\n* Active infection at the surgical site.\n* Uncontrolled coagulopathy.\n* Unfit patients for surgery due to severe medical illness.\n* Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.\n* Irresectable tumors in diagnostic laparoscopy.\n* Patients requiring left, central or total pancreatectomy or other palliative surgery.\n* Pregnant or breastfeeding women.\n* Patients with serious mental disorders.\n* Patients with vascular invasion and requiring vascular resection.\n* Patients refused to participate in the study.","ALL","18 Years","75 Years",{"count":75,"type":76},90,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","This randomized controlled trial investigates the safety and efficacy of injecting N-butyl-2- cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.",[82,83,84,85],"Pancreaticoduodenectomy","Postoperative Pancreatic Fistula","Pancreas Cancer","Periampullary Cancer",[87,88,89,90,91,92],"Pancreatic surgery","Anastomotic leak","Tissue adhesive","Postoperative Pancreatic Fistula (POPF)","Pancreaticoduodenectomy (PD)","Pancreaticojejunostomy (PJ)","2025-11-30",{"date":95,"type":96},"2025-12-02","ACTUAL",{"date":98,"type":96},"2025-12-01",{"date":100,"type":76},"2027-12-20",{"name":5,"class":6},1]