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

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 s

Trial Details

NCT ID
NCT07155525
Phase
PHASE3
Sponsor
Minia University
Status
RECRUITING
Cancer Type
Pancreatic Ductal Adenocarcinoma Pancreatic Cancer
Interventions
  • Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)
  • Standard(duct-to-mucosa) Pancreaticojejunostomy
Locations (sample)
  • Minya, Minya Governorate, Egypt|28.09193,30.75813

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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