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OncoMatch/Clinical Trials/NCT07155525

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

Is NCT07155525 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) for pancreatic cancer.

Phase 3RecruitingMinia UniversityNCT07155525Data as of May 2026

Treatment: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)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.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Cholangiocarcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: pancreatic surgery or pancreatic anastomosis

Previous pancreatic surgery or pancreatic anastomosis

Lab requirements

Blood counts

Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1,500/μL; Platelet count ≥ 100,000/μL

Kidney function

Serum creatinine ≤ 1.5 times upper limit of normal

Liver function

Total bilirubin ≤ 3 times upper limit of normal; ALT ≤ 5 times upper limit of normal

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) ≤ 5 times upper limit of normal Serum creatinine ≤ 1.5 times upper limit of normal

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