Efficacy of Pancreatic Parenchymal N-Butyl-2-Cyanoacrylate Injection in Pancreaticojejunostomy After Pancreaticoduodenectomy: A Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the use of N-butyl-2-cyanoacrylate (Histoacryl4) injection into the pancreatic tissue during pancreaticoduodenectomy (PD) to improve the security of the pancreaticojejunostomy (PJ) connection and reduce the occurrence of postoperative pancreatic fistula (POPF). This phase 2 randomized controlled trial aims to provide strong evidence on the safety and effectiveness of this approach for patients undergoing PD, a surgery often complicated by POPF which increases risks and healthcare costs. The study randomly assigns about 90 patients undergoing PD to one of two groups. The experimental group receives an injection of N-butyl-2-cyanoacrylate mixed with Lipiodol4 around the pancreatic duct area during surgery, followed by the usual pancreaticojejunostomy and other reconstructions. The control group undergoes the standard surgical technique without any injection or sealant applied. No placebo injection is given in the control arm. Participants are monitored for up to 90 days after surgery for the main outcome: the rate of postoperative pancreatic fistula as defined by international standards. Secondary measures include rates of acute pancreatitis, post-surgery bleeding, abdominal abscesses, biliary fistula, hospital readmission, reoperation, mortality, and other complications. The trial tracks these outcomes carefully to assess the potential benefits and risks of the cyanoacrylate injection compared to standard care. Total participation lasts through the postoperative monitoring period.

Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate