Status:
RECRUITING
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
Lead Sponsor:
Minia University
Conditions:
Pancreatic Cancer
Periampullary Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 c...
Detailed Description
Postoperative pancreatic fistula (POPF) remains the most common and serious complication following pancreaticoduodenectomy, with incidence rates reaching up to 56.7% in patients with soft pancreatic t...
Eligibility Criteria
Inclusion
- 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.
- Adequate organ function defined as:
- Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count ≥ 1,500/μL Platelet count ≥ 100,000/μL Total bilirubin ≤ 3 times upper limit of normal Alanine transaminase (ALT) /Alanine transaminase (ALT)( ≤ 5 times upper limit of normal Serum creatinine ≤ 1.5 times upper limit of normal
- Informed consent provided.
- Willingness to comply with study procedures and follow-up requirements.
Exclusion
- Hard pancreatic texture (intraoperative surgeon assessment).
- Emergency surgery.
- Previous pancreatic surgery or pancreatic anastomosis.
- Intraoperative identification of unresectable disease
- Known allergy to cyanoacrylate or components.
- Pregnancy or lactation.
- Active infection or sepsis.
- Inability to comply with follow-up.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2028
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT07155525
Start Date
September 15 2025
End Date
November 15 2028
Last Update
September 18 2025
Active Locations (1)
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1
Liver and GIT hospital , Minia University
Minya, Minya Governorate, Egypt, 61519