Does fibrin glue sealant decrease the rate of anastomotic leak after a pancreaticoduodenectomy? Results of a prospective randomized trial

AbstractBackgroundThe aim of this study was to evaluate the effect of topical fibrin glue applied externally to all anastomoses after a pancreaticoduodenectomy (PD) on drain lipase levels, anastomotic leaks, complication rates and length of hospital stay.MethodsA standardized non‐pylorus preserving PD was performed with or without fibrin glue applied to each anastomosis.ResultsFifty‐seven patients were randomized: 32 with and 25 without TISSEEL. There were no statistical differences in each group with respect to drain lipase levels (high 40% versus 43%, P = 0.794), complications including gastric or biliary leaks (24% versus 28%, P = 1.00), wound infection (16% versus 9%, P = 0.28) and a Clavien score of 3 or more (16% versus 25%, P = 0.757) or hospital stay (12 versus 17 days, P = 0.777). Most patients with elevated drain lipase levels had an unaltered clinical course not predictive of adverse outcomes. However, the operative finding of a soft pancreas (27 out of 57 patients) was associated with post‐operative complications (P = 0.002). There were no peri‐operative deaths.Conclusions1Fibrin glue application to all anastomoses does not alter drain lipase levels.2Drain lipase levels are not a significant surrogate marker for clinically significant anastomotic leaks or complications.3Fibrin glue application did not reduce the incidence of an anastomotic leak or complications