[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603132":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":50,"collaborators":53,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":53,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":77,"overallStatus":35,"whyStopped":53,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Minia University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group.","EXPERIMENTAL","Patients in this group will receive pancreatic parenchymal injection of N-butyl-2-cyanoacrylate during pancreaticoduodenectomy.",[13],"Drug: Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)","This procedure is integrated into the standard pancreaticoduodenectomy.\n\nInjection 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.\n\nFollow 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\n\nReconstruction: Complete the hepaticojejunostomy and duodenojejunostomy (or gastrojejunostomy).",[9],[21],"Histoacryl®, N-butyl-2-cyanoacrylate, Tissue adhesive injection",[23],{"name":24,"affiliation":5,"role":25},"Saleh K Saleh, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","01201765401","+2","salehkhairy@mu.edu.eg",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Liver and GIT hospital , Minia University","RECRUITING","Minya","Minya Governorate","61519","Egypt","EG",{"type":42,"coordinates":43},"Point",[44,45],30.75813,28.09193,{"lat":45,"lon":44},[48],{"name":24,"role":28,"phone":49,"phoneExt":30,"email":31},"+201201765401",{"type":25,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Saleh Khairy Saleh MD","Lecturer",null,"100603132","phase-1-salehs-technique-for-pancreaticojejunostomy-pancreatic-parenchymal-injection-of-n-butyl-2-cyanoacrylate-100603132",false,"NCT07132541","Saleh's Technique for Pancreaticojejunostomy (Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate)","Pancreatic Parenchymal Injection of N-Butyl-2-Cyanoacrylate for Pancreaticojejunostomy After Pancreaticoduodenectomy: A Novel Technique","NBCA","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":66,"type":67},30,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","This study 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.",[73,74,75,76],"Pancreaticoduodenectomy","Postoperative Pancreatic Fistula","Pancreas Cancer","Periampullary Cancer",[78,79,80,81,82,83],"Pancreatic surgery","Anastomotic leak","Tissue adhesive","Postoperative Pancreatic Fistula (POPF)","Pancreaticoduodenectomy (PD)","Pancreaticojejunostomy (PJ)","2025-08-25",{"date":86,"type":87},"2025-09-02","ACTUAL",{"date":84,"type":87},{"date":90,"type":67},"2026-09-25",{"name":5,"class":6},1]