NCT07155525 Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
| NCT ID | NCT07155525 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Minia University |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2028-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 194 participants in total. It began in 2025-09-15 with a primary completion date of 2028-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Saleh K Saleh, MD
PRINCIPAL INVESTIGATOR
Minia University
Frequently Asked Questions
Who can join the NCT07155525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07155525 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 194 participants.
Is NCT07155525 currently recruiting?
Yes, NCT07155525 is actively recruiting participants. Contact the research team at salehkhairy@mu.edu.eg for enrollment information.
Where is the NCT07155525 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07155525 clinical trial?
NCT07155525 is sponsored by Minia University. The principal investigator is Saleh K Saleh, MD at Minia University. The trial plans to enroll 194 participants.
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