Human fibrin sealant in pancreatic surgery: it is useful in preventing fistulas? A prospective randomized study.

Some Authors have suggested the use of human fibrin sealants in pancreatic surgery to prevent fistulas. We performed a prospective randomized study including 97 patients (34F, 63M). Forty six were affected by pancreatic inflammatory diseases and 51 had pancreatic or peripancreatic neoplasms. All the patients were managed by the same surgical staff. Surgical treatment included 30 pancreaticoduodenectomies, 40 pancreatico-jejunostomies, 23 left pancreatic resections and 4 tumour excisions. The patients were randomized at the moment the surgical treatment was chosen and divided into 2 different groups: group A, including 43 subjects who had intraoperative fibrin sealing, and group B, including 54 patients who had no fibrin sealing during surgery. At the end of the trial, 6 patients in group A (13.9%) and 6 in group B (11.1%) developed a pancreatic fistula. No statistically significant difference was detected between the 2 groups. The highest incidence of fistulas was observed in the patients with pancreatic cancer in group A (18.7%) and in the patients who underwent pancreatico-duodenectomy in group A (25.0%).

RCT Entities:   Population Interventions Outcomes