Efficacy of octreotide in the prevention of pancreatic fistula after elective pancreatic resections: a prospective, controlled, randomized clinical trial

Background. A prospective, randomized controlled clinical trial was conducted in 33 Italian surgical departments with the aim of evaluating the efficacy of octreotide in the prevention of pancreatic fistula after elective pancreatic resections. Methods. Between July 1990 and May 1992, 278 patients were enrolled in the study. Fifty-four dropped out because of unresectable disease and six were excluded because of protocol violation; the remaining 218 were randomly assigned to the octreotide group (n=111) or to the placebo group (n=107). There were 131 men and 87 women with a mean age of 58.2±11.7 yrs. Pancreaticoduodenectomy was the most common operation performed (n=143), sixty-four percent of patients had a pancreatic or periampullary cancer; chronic pancreatitis accounted for 8.2% of cases. Results. Mortality rate was 6.9%. A pancreatic fistula occurred in 31 patients (14.2%), 9% in the octreotide group and 19.6% in the placebo group (p<0.05). Morbidity rate was significantly lower in the octreotide (21.6%) than in the placebo group (36.4%) (p<0.05). When specific pancreatic complications were grouped together and evaluated, they occurred less frequently in the treated (15.3%) than in the placebo group (29.9%) (p<0.05). Conclusions. Octreotide was able to reduce significantly the incidence of pancreatic fistula after elective pancreatic resections.