The 30-Day Follow-up of the Pancreas Cohort of the SHIELDS Trial (Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage Following Elective Hepatobiliary and Pancreatic Surgery)

Abstract

Pancreatic fistulas (POPF) still belong to the most harmful complications following hepato-pancreato-biliary (HPB) surgery. The incidence for clinically relevant POPF (type B and C pancreatic fistulas as defined by the ISGPS) vary in literature, around 21% (type B) and 3% (type C). However, none of the available sealants can significantly reduce POPF. In order to reduce POPF and to achieve bleeding control a new biodegradable sealant has been developed. In a preclinical porcine distal pancreatectomy model the sealant was able to reduce POPF and was superior to the standard of care.