NCT07155525Recruiting
Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
Pancreaticojejunostomy With or Without Modified N-butyl-2-cyanoacrylate Following Pancreaticoduodenectomy in Soft Pancreas: Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 194 (estimated)
- First submitted
- 27 Aug 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 15 Sept 2028
- Lead sponsor
- Minia University
- NCT number
- NCT07155525
What you commit to
- Study type: Interventional
- Planned participants: 194
- From 15 Sept 2025 to the primary completion date, 15 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery.
- Previous pancreatic surgery or pancreatic anastomosis.
Other illness
- Intraoperative identification of unresectable disease
- Known allergy to cyanoacrylate or components.
- Active infection or sepsis.
Other
- Hard pancreatic texture (intraoperative surgeon assessment).
- Pregnancy or lactation.
- Inability to comply with follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liver and GIT hospital , Minia University Coordinator of this site? Confirm its status | Minya | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.