Efficacy of PuraStat for Oozing Hemorrhage From the Pancreatic Stump During Distal Pancreatectomy: A Prospective Exploratory Study.

INTRODUCTION

Oozing hemorrhage from the stapled pancreatic stump is frequently encountered during distal pancreatectomy (DP) and may require additional hemostatic procedures that can potentially injure the pancreatic parenchyma. Although PuraStat, a synthetic self-assembling peptide, enables atraumatic hemostasis, its efficacy and safety in pancreatic surgery remain unclear.

METHODS

The EASY-STOP study was a single-center, prospective, single-arm exploratory study evaluating the use of PuraStat for oozing hemorrhage from the stapled pancreatic stump during DP. The primary outcome was the proportion of bleeding sites requiring additional hemostatic procedures. Secondary outcomes included time to hemostasis, preparation time, amount of PuraStat used, and perioperative outcomes. All patients were followed for 90 d after surgery to assess postoperative safety.

RESULTS

Between February and November 2024, 37 patients were enrolled, of whom 21 patients receiving PuraStat were included in the analysis; among them, 19 patients underwent robotic DP. PuraStat was applied to 22 bleeding sites, as one patient had two distinct bleeding sites. Additional hemostatic procedures were required in 18% (4/22) of the sites. The median time to hemostasis and preparation time were 22 s and 114 s, respectively. The median amount of PuraStat used per site was 1.0 mL. No intraoperative complications, postoperative rebleeding, or severe adverse events were observed.

CONCLUSIONS

PuraStat enabled rapid hemostasis of oozing hemorrhage from the stapled pancreatic stump during DP. The present findings suggest that PuraStat may be a feasible adjunct for atraumatic management of stump bleeding in pancreatic surgery.