Tissue adhesive (Glubran®2) to reinforce pancreaticojejunostomy in soft pancreas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.