Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate
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.
| Condition(s) | Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Pancreas Cancer, Periampullary Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Patients undergoing pancreaticoduodenectomy for malignant lesions meeting the curative treatment intent in accordance with clinical guidelines. * Soft pancreatic texture. * Small main pancreatic duct diameter (\<3 mm). * Informed consent obtained. Exclusion Criteria: * Known hypersensitivity to cyanoacrylate or Lipiodol®. * Extremely hard, fibrotic pancreas. * Significant pancreatitis involving the pancreatic remnant. * Active infection at the surgical site. * Uncontrolled coagulopathy. * Unfit patients for surgery due to severe medical illness. * Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs. * Irresectable tumors in diagnostic laparoscopy. * Patients requiring left, central or |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Minia University |
| Locations | Minya, Minya Governorate, Egypt |
| Start date | 2025-12-01 |
| NCT ID | NCT07230509 |
| Official listing | https://clinicaltrials.gov/study/NCT07230509 |