drugset / Trial / NCT06756074

Reinforced Pancreaticojejunostomy With or Without glubran2

NCT06756074 ↗

Phase 2 Recruiting 100 enrolled Minia University
RandomizedParallel-groupDouble-blindTreatment

Summary

Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend different techniques in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula by enforce pancreaticojejunostomy with tissue glue .

Timeline

Start
2025-01-15
Primary completion
2026-04-15
Completion
2026-05-15

Outcome

Met primary endpoint

paper POPF (Grade B/C) occurred in 3 patients (6%) in the Glubran®2 group versus 11 patients (22%) in the Control group (p = 0.041; Fisher's exact test). PMID 42381068 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Glubran®2 Unknown — —