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
Parallel
Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)
Drug* Standard duct-to-mucosa pancreaticojejunostomy performed * Application of 0.5-1.0 mL modified N-butyl-2-cyanoacrylate around the anastomotic site * Adhesive applied circumferentially around the pancreaticojejunal anastomosis * Allow 2-3 minutes for polymerization before proceeding * Standard placement of peritoneal drains
Standard(duct-to-mucosa) Pancreaticojejunostomy
Procedure/Surgery* Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy. * Standard placement of peritoneal drains * All other aspects of surgical care identical to experimental arm
Incidence of Postoperative Pancreatic Fistula (POPF).
Percentage of patients developing postoperative pancreatic fistula as defined by International Study Group on Pancreatic Fistula (ISGPF) criteria. POPF is defined as drain output of any measurable volume of fluid on or after postoperative day 3 with amylase content greater than 3 times the upper normal serum value. Graded as A (biochemical leak), B , or C.
Time to POPF resolution.
Number of days from surgery to complete resolution of pancreatic fistula.
Postoperative complications
Incidence of delayed gastric emptying, bile leak, wound infection, intra-abdominal abscess, and other complications.
Reoperation Rate
Percentage of patients requiring reoperation for complications.
Length of Hospital Stay
Total number of days in hospital following surgery(days).
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