Randomized controlled multicentre trial of somatostatin infusion after pancreaticoduodenectomy

Background: It remains debatable whether somatostatin can prevent pancreatic fistula and other pancreatic stump-related complications following pancreaticoduodenectomy. This study assessed the effects of somatostatin-14 (S-14) on pancreatic remnant exocrine secretion. Methods: This was a double-blind, randomized, placebo-controlled trial in patients undergoing pancreaticoduodenectomy for malignancy. Patients received a continuous infusion of S-14 (n=38) or placebo (n=37) for 7 days. Pancreatic juice and peripancreatic drainage fluid was collected and measured, and pancreatic enzymes were monitored daily. Postoperative complications were recorded. Results: S-14 infusion was associated with a decrease in median daily pancreatic juice and pancreatic amylase output. Amylase concentration and output in the peripancreatic drain fluid were significantly lower after S-14 infusion than in the control group (both P<0.05). The incidence of clinical pancreatic fistula (two of 38 versus eight of 37; P<0.05) and total pancreatic stump-related complications (five of 38 versus 12 of 37; P<0.05) was lower in patients treated with S-14. Duration of hospital stay was shorter after S-14 (18 versus 26 days; P=0.01). Conclusion: Although the effect of S-14 on exocrine secretion remains difficult to demonstrate, it did reduce pancreatic juice leakage from the pancreatic remnant.