RECRUITINGPhase 2INTERVENTIONAL

Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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). - willing to sign a consent form obtained. Who Should NOT Join This Trial: - 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 total pancreatectomy or other palliative surgery. - Pregnant or breastfeeding women. - Patients with serious mental disorders. - Patients with vascular invasion and requiring vascular resection. - Patients refused to participate in the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 total pancreatectomy or other palliative surgery. * Pregnant or breastfeeding women. * Patients with serious mental disorders. * Patients with vascular invasion and requiring vascular resection. * Patients refused to participate in the study.

Treatments Being Tested

DRUG

Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group.

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).

PROCEDURE

Standard Pancreaticojejunostomy

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.

Locations (1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, Egypt