Actively Recruiting
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
Led by Minia University · Updated on 2025-09-18
194
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for elective pancreaticoduodenectomy for malignant lesions
- Soft pancreatic texture confirmed by surgeon palpation during surgery
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ function defined as hemoglobin 9.0 g/dL, absolute neutrophil count 1,500/bcL, platelet count 100,000/bcL, total bilirubin 3 times upper limit of normal, alanine transaminase (ALT) 5 times upper limit of normal, serum creatinine 1.5 times upper limit of normal
- Provided informed consent
- Willingness to comply with study procedures and follow-up
You will not qualify if you...
- Hard pancreatic texture as assessed during surgery
- Emergency surgery
- Previous pancreatic surgery or pancreatic anastomosis
- Intraoperative finding of unresectable disease
- Known allergy to cyanoacrylate or its components
- Pregnancy or breastfeeding
- Active infection or sepsis
- Inability to comply with follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Liver and GIT hospital , Minia University
Minya, Minya Governorate, Egypt, 61519
Actively Recruiting
Research Team
S
Saleh K Saleh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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