Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinia University

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Known hypersensitivity to cyanoacrylate or Lipiodol®.

Extremely hard, fibrotic pancreas.

Significant pancreatitis involving the pancreatic remnant.

Active infection at the surgical site.

Trial design

Treatments tested in this trial

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

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators