New Technique Using N-Butyl-2-Cyanoacrylate Injection During Pancreaticoduodenectomy to Improve Pancreaticojejunostomy Safety and Reduce Fistula Risk

What this Trial Is About

Researchers are evaluating the safety and effectiveness of injecting N-butyl-2-cyanoacrylate Histoacryl4 into the pancreas during pancreaticoduodenectomy surgery. The goal is to strengthen the connection between the pancreas and small intestine pancreaticojejunostomy to reduce the risk of leaks called postoperative pancreatic fistulas, which are common after this surgery. This Phase 1 study focuses on patients with soft pancreas tissue and small pancreatic ducts undergoing surgery for cancers such as pancreatic, periampullary, cholangiocarcinoma, or duodenal cancer. During the surgery, a mixture of Histoacryl4 and Lipiodol4 is carefully injected around the pancreatic duct opening in the pancreas tissue, avoiding the duct and blood vessels. The total injected amount ranges from 0.2 to 0.6 ml. After injection, the standard surgical connection between the pancreas and intestine is completed along with other reconstructions such as bile duct and stomach connections. This procedure is integrated into the standard pancreaticoduodenectomy operation. Participants will have preoperative, intraoperative, and postoperative data collected and analyzed. Researchers will monitor for pancreatic fistulas within 10 days after surgery as the primary outcome. Secondary outcomes include rates of pancreatitis, bleeding, abscesses, biliary fistulas, and hospital readmissions up to 90 days post surgery. The study will enroll 30 patients from July 2025 to July 2026, with close follow-up to evaluate safety and impact on surgical outcomes.

Saleh's Technique for Pancreaticojejunostomy (Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate)