Effect of BioGlue® on the incidence of pancreatic fistula following pancreas resection

Background Despite numerous modifications of surgical technique, pancreatic fistula remains a serious problem and occurs in about 10% of patients following pancreas resection. BioGlue is a new sealant that creates a flexible mechanical seal within minutes independent of the body's clotting mechanism. Hypothesis Application of BioGlue sealant will reduce the incidence of pancreatic fistula following pancreas resection. Methods A retrospective cohort study was performed with 64 patients undergoing pancreas resection. BioGlue sealant was applied to the pancreatic anastomosis (Whipple) or resection margin (distal pancreatectomy) in 32 cases. Factors that could affect the rate of postoperative pancreatic fistula were recorded. Pancreatic fistula was defined as greater than 50 ml of drain output with an amylase content greater than three times normal serum value after postoperative day 10. To improve the sensitivity of our study, we also examined pancreatic fistula with a strict definition of any drain output on or after postoperative day 3 with a high amylase content and graded the fistulas in terms of clinical severity. Grade A leaks were defined as subclinical. Grade B leaks required some response such as making the patient nil per os, parenteral nutrition, octreotide, antibiotics, or a prolonged hospital stay. Grade C leaks were defined as serious and life threatening. They were associated with hemorrhage, sepsis, resulted in deterioration of other organ systems, and mandated intensive care. Comparisons between the two groups were made using the chi-square test or Fisher's exact test for categorical variables and by the Wilcoxon rank-sum test for continuous variables. P values of 0.05 or less were deemed statistically significant. Results There were no differences between the patients who received BioGlue and the control cohort in terms of comorbid conditions, tumor location, texture of the pancreas, size of the pancreatic duct, or surgical technique. By the common definition, pancreatic fistula occurred in 6% (control) vs. 22% (BioGlue). By the strict definition, a fistula occurred in 41% (control) vs. 60% (BioGlue). In the control group, ten were subclinical (grade A) and two were clinically apparent leaks (grade B). In the BioGlue group, seven were subclinical (grade A), five were clinically apparent (grade B), and three were severe (grade C). There were no statistically significant differences in the incidence or severity grades of postoperative pancreatic fistulas between the two groups. Conclusion Application of BioGlue sealant probably does not reduce the incidence of pancreatic fistula following pancreas resection.