[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603132":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":48,"overallOfficials":56,"centralContacts":60,"locations":66,"responsibleParty":84,"collaborators":32,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":32,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":110,"overallStatus":69,"whyStopped":32,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Minia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of postoperative pancreatic fistula","A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day.","10 days",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Incidence of postoperative acute pancreatitis","Altered serum amylase count on postoperative day 0 or 1","1 day post index surgery",{"measure":19,"description":20,"timeFrame":21},"Incidence of Post-Pancreatectomy Hemorrhage","As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates","90 days",{"measure":23,"description":24,"timeFrame":21},"Incidence of intra-abdominal abscess","Collection containing gas bubbles, determining systemic signs of infection",{"measure":26,"description":27,"timeFrame":21},"Incidence of biliary fistula","Output of bile from drains on or by post operative day 3",{"measure":29,"description":30,"timeFrame":31},"Rate of readmission","New admission within 30 days of discharge from hospital","30 days after hospital discharge",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"NA","SINGLE_GROUP","Patients receiving pancreatic parenchymal injection of N-butyl-2-cyanoacrylate (Histoacryl®) during pancreaticojejunostomy","TREATMENT",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","Postoperative pancreatic fistula (POPF) remains one of the most significant complications following pancreaticoduodenectomy (PD), with rates ranging from 10% to 30% depending on pancreatic texture and duct size. This study aims to evaluate the use of Histoacryl®, a tissue adhesive, injected into the pancreatic parenchyma to seal leaks and reinforce the anastomotic suture line, particularly in soft pancreases. The study will assess the safety, feasibility, and impact on clinically relevant POPF rates while maintaining exocrine drainage and minimizing parenchymal leakage. Thirty consecutive patients undergoing PD for pancreatic cancer, periampullary cancer, cholangiocarcinoma, or duodenal cancer will be enrolled between July 2025 and July 2026. Preoperative, intraoperative, and postoperative data will be collected and analyzed.",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group.","EXPERIMENTAL","Patients in this group will receive pancreatic parenchymal injection of N-butyl-2-cyanoacrylate during pancreaticoduodenectomy.",[47],"Drug: Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"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).",[43],[55],"Histoacryl®, N-butyl-2-cyanoacrylate, Tissue adhesive injection",[57],{"name":58,"affiliation":5,"role":59},"Saleh K Saleh, MD","PRINCIPAL_INVESTIGATOR",[61],{"name":58,"role":62,"phone":63,"phoneExt":64,"email":65},"CONTACT","01201765401","+2","salehkhairy@mu.edu.eg",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Liver and GIT hospital , Minia University","RECRUITING","Minya","Minya Governorate","61519","Egypt","EG",{"type":76,"coordinates":77},"Point",[78,79],30.75813,28.09193,{"lat":79,"lon":78},[82],{"name":58,"role":62,"phone":83,"phoneExt":64,"email":65},"+201201765401",{"type":59,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Saleh Khairy Saleh MD","Lecturer","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":99,"type":100},30,"ESTIMATED","INTERVENTIONAL",[103],"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.",[106,107,108,109],"Pancreaticoduodenectomy","Postoperative Pancreatic Fistula","Pancreas Cancer","Periampullary Cancer",[111,112,113,114,115,116],"Pancreatic surgery","Anastomotic leak","Tissue adhesive","Postoperative Pancreatic Fistula (POPF)","Pancreaticoduodenectomy (PD)","Pancreaticojejunostomy (PJ)","2026-09-08",{"date":119,"type":120},"2026-09-11","ACTUAL",{"date":122,"type":120},"2025-08-25",{"date":124,"type":100},"2026-12-25",{"name":5,"class":6},1]