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

Summary

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.

Timeline

Start

2025-09-15

Primary completion

2028-09-15

Completion

2028-11-15

Publications

• Results Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
• Results Gaspar AF, Kemp R, Sankarankutty AK, Lopes Junior JR, Filho JAF, Avezum VAPAF, de Assis Mota G, Nunes AA, Dos Santos JS. Influence on Postoperative Results and Cost-effectiveness of Using Cyanoacrylate Glue for Pancreaticojejunal Anastomosis After Duodenopancreatectomy. Pancreas. 2025 Aug 1;54(7):e610-e617. doi: 10.1097/MPA.0000000000002479.

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