At a glance
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Efficacy of Pancreatic Parenchymal N-Butyl-2-Cyanoacrylate Injection in Pancreaticojejunostomy After Pancreaticoduodenectomy: A Randomized Controlled Trial
In Brief
A Phase 2 clinical trial evaluating Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group. and Standard Pancreaticojejunostomy for Pancreaticoduodenectomy and 3 related conditions. Currently recruiting, targeting 90 participants across 1 site.
Detailed Summary
This randomized controlled trial 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.
Study Details
Timeline
Interventions
This procedure is integrated into the standard pancreaticoduodenectomy. Injection 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. Follow with standard duct-to-mucosa pancreaticojejunostomy: * Tying down the posterior duct-to-mucosa sutures. * Placing and tying the anterior duct-to-mucosa sutures. * Tying down the posterior outer layer sutures. * Placing the anterior outer layer sutures. Meticulously avoid glue contact with sutures/mucosa Reconstruction: Complete the hepaticojejunostomy and duodenojejunostomy (or gastrojejunostomy).
Patients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy using the standard surgical technique of the institution, without the application of N-Butyl-2-Cyanoacrylate or any other sealant to the pancreatic anastomosis. No placebo injection will be administered.