RecruitingPhase 3

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

Egypt194 participantsStarted 2025-09-15

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Postoperative Pancreatic Fistula (POPF).

Timeframe: 30 days post-surgery.

Trial details

NCT IDNCT07155525

SponsorMinia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-15

Contact for this trial

Saleh K Saleh, MD

+201201765401 salehkhairy@mu.edu.eg

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