Prevention of pancreatic fistula with a new synthetic, absorbable sealant:: Evaluation in a dog model

BACKGROUND: Pancreatic fistula complicates up to 15% to 25% of pancreatic resections, especially with soft, normal pancreas, and is most common after distal pancreatectomy. A new synthetic, absorbable hydrogel sealant has recently been developed and tested for sealing of human aorta, bronchi, and dura; it is FDA approved as a lung sealant in humans. Our objective was to test the efficacy of the sealant in preventing pancreatic leaks in a dog model of distal pancreatectomy. STUDY DESIGN: Ten dogs underwent bilateral distal pancreatectomy under general anesthesia. Animals were randomized to receive application of the sealant to the pancreatic stumps (n = 5) or no treatment (n = 5). The transected pancreatic duct was not ligated, and the end of the pancreas was neither oversewn nor stapled; closed-suction drains were placed in proximity to the pancreatic stumps before abdominal closure. All animals received normal chow starting on the second postoperative day. Drainage was collected for volume and amylase determination twice daily for 14 days, after which the animals were sacrificed. Pancreatic tissue was collected from the area of transection and was formalin fixed for histopathology. RESULTS: There was no perloperative mortality. Fluid recovered from closed-suction drains in all animals was uniformly amylase-rich. Over the 14-day study period, daily volume of pancreatic drainage was significantly different between control animals and animals treated with sealant (p < 0.001). By postoperative day 6, the total mean pancreatic drainage in dogs treated with sealant was 25 +/- 5 mL/drain (versus 91 +/- 26 mL/drain in untreated dogs; p < 0.05). This is the point at which we remove the drains in our clinical practice. Examination at 14 days revealed intact sealant at the pancreatic stumps in the treatment group, and histopathology showed a characteristic benign histiocyte reaction to the sealant but no other qualitative differences in the degree of inflammation between control and treatment animals. There were no undrained collections or abscesses. CONCLUSIONS: A new synthetic hydrogel sealant prevents the formation of significant pancreatic fistulae after distal pancreatectomy in the dog and may be suitable for clinical application. (C) 2002 by the American College of Surgeons.