ConditionsPancreaticoduodenectomyPostoperative Pancreatic FistulaPancreas CancerPeriampullary Cancer
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 groupsSponsors and collaborators
Source ClinicalTrials.gov