Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas

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.

NCT Number	NCT07155525
Lead Sponsor	Minia University
Conditions	Pancreatic Cancer, Periampullary Cancer, Duodenal Cancer, Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Head Mass, Bile Duct Cancer
Enrollment	194 participants
Start Date	2025-09-15
Primary Completion	2028-09-15 (estimated)
Study Completion	2028-11-15 (estimated)
Updated on ClinicalTrials.gov	2025-09-18