Tissue adhesive (Glubran®2) to reinforce pancreaticojejunostomy in soft pancreas
Pancreaticojejunostomy With or Without Modified N-butyl-2-cyanoacrylate Following Pancreaticoduodenectomy in Soft Pancreas: Randomized Controlled Trial
This trial will test whether adding a tissue adhesive glue (Glubran®2) to the pancreatic-jejunal connection reduces postoperative pancreatic leaks in adults with a soft pancreas undergoing pancreaticoduodenectomy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07155525 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective, randomized phase III trial enrolling about 194 adults undergoing elective pancreaticoduodenectomy for malignant disease who are confirmed intraoperatively to have a soft pancreatic texture. Participants are randomized intraoperatively to receive either standard duct-to-mucosa pancreaticojejunostomy or the same anastomosis with application of modified N-butyl-2-cyanoacrylate (Glubran®2). The primary endpoint is the incidence of postoperative pancreatic fistula (POPF) within 30 days using ISGPF criteria, and secondary endpoints include surgical complications and length of hospital stay. Randomization uses computer-generated blocks and all procedures are performed at a single tertiary surgical center.
Who should consider this trial
Good fit: Adults aged 18–75 with malignant disease scheduled for elective pancreaticoduodenectomy who have intraoperatively confirmed soft pancreatic texture, ECOG 0–2, adequate organ function, and provide informed consent are ideal candidates.
Not a fit: Patients with a hard/fibrotic pancreas, emergency surgery, prior pancreatic anastomosis, known allergy to cyanoacrylate, unresectable disease identified intraoperatively, or pregnancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could lower rates of postoperative pancreatic fistula, reduce related complications, and shorten hospital stays.
How similar studies have performed: Small series and pilot studies of tissue sealants, including cyanoacrylate formulations, have suggested reductions in pancreatic fistula rates but high-quality, definitive phase III evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. * 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 Criteria: * 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.
Where this trial is running
Minya, Minya Governorate
- Liver and GIT hospital , Minia University — Minya, Minya Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Saleh K Saleh, MD — Minia University
- Study coordinator: Saleh K Saleh, MD
- Email: salehkhairy@mu.edu.eg
- Phone: +201201765401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.