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.
Patients scheduled for elective pancreaticoduodenectomy for malignant lesions.
Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).
Age 18-75 years .
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Hard pancreatic texture (intraoperative surgeon assessment).
Emergency surgery.
Previous pancreatic surgery or pancreatic anastomosis.
Intraoperative identification of unresectable disease
Minia University
Lead sponsor