Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinia University

About this trial

This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with soft pancreatic texture. The primary endpoint is the incidence of postoperative pancreatic fistula at 30 days post-surgery, as defined by the International Study Group on Pancreatic Fistula (ISGPF) criteria.Secondary outcomes include surgical complications and length of hospital stay. The study will enroll approximately 194 patients at a single center.

Eligibility criteria

Qualifiers

Patients scheduled for elective pancreaticoduodenectomy for malignant lesions.

Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).

Age 18-75 years .

Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Disqualifiers

Hard pancreatic texture (intraoperative surgeon assessment).

Emergency surgery.

Previous pancreatic surgery or pancreatic anastomosis.

Intraoperative identification of unresectable disease

Trial design

Treatments tested in this trial

  • Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)
  • Standard(duct-to-mucosa) Pancreaticojejunostomy

Treatment groups

194 Participants
are divided into 2 treatment groups

Sponsors and collaborators