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

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

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.

Conditions8

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