Prospectively randomized trial using perioperative low dose octreotide to prevent organ related and general complications following pancreatic surgery and pancreatico-jejunostomy

Background: The aim of the study was to evaluate the influence of low dose perioperative Octreotide on the prevention of complications (pancreatic fistula and general complications) in patients undergoing pancreatic surgery followed by pancreatico-jejunostomy. Material and Methods : 105 patients were randomized to receive either Octreotide 0.1 mg subcutaneously 3 times/day for a total of 7 days or no Octreotide. The primary endpoints were the occurrence of a pancreatic fistula and/or general complications including the length of hospital stay. There were 25 surgical draining procedures performed and 80 duodeno-pancreatectomies with or without preservation of the pylorus. Twenty-six (24.8%) of the patients were treated for chronic pancreatitis, 8 (7.6%) for benign tumoral disease and 71 (67.6%) for carcinoma. All patients underwent pancreatico-jejunostomy. Results : 56 patients received Octreotide and 49 did not. The incidence of fistula formation in the Octreotide group was 8.9% (n = 5) and in the control group 8.2% (n = 4) for a total incidence of 8.5%. The difference between the two groups was not statistically significant. There was one death in the Octreotide group and none in the control group for an overall mortality of 0.9%. The morbidity, except fistulas, was 10.7% in the Octreotide group and 12.2% in the control group. The length of hospital stay was 23.1 +/- 15.1 days in the group receiving Octreotide vs 20.4 +/- 8.1 days in the control group (p = 0.808). Stratifying the data for duodenopancreatectomy and for draining procedures there was no difference between the groups either. Conclusion : In patients undergoing pancreatic surgery and pancreatico-jejunostomy, the perioperative use of 3 x 0.1 mg Octreotide for 7 days does not reduce general complications nor fistula formation.