Postoperative pancreatic fistula is a major contributor to complications and death associated with pancreatic resection. Pasireotide ( Signifor ), a somatostatin analogue that has a longer half-life than Octreotide and a broader binding profile, decreases pancreatic exocrine secretions and may prevent postoperative pancreatic fistula.
Researchers have conducted a single-center, randomized, double-blind trial of perioperative subcutaneous Pasireotide in patients undergoing either pancreaticoduodenectomy or distal pancreatectomy.
A total of 300 patients was randomly assigned to receive 900 mcg of subcutaneous Pasireotide ( 152 patients ) or placebo ( 148 patients ) twice daily beginning preoperatively on the morning of the operation and continuing for 7 days ( 14 doses ).
Randomization was stratified according to the type of resection and whether the pancreatic duct was dilated at the site of transection.
The primary end point was the development of pancreatic fistula, leak, or abscess of grade 3 or higher ( i.e., requiring drainage ).
The primary end point occurred in 45 of the 300 patients ( 15% ). The rate of grade 3 or higher postoperative pancreatic fistula, leak, or abscess was significantly lower among patients who received Pasireotide than among patients who received placebo ( 9% vs 21%; relative risk, RR=0.44; P=0.006 ).
This finding was consistent among 220 patients who underwent pancreaticoduodenectomy ( 10% vs 21%; RR=0.49 ) and 80 patients who underwent distal pancreatectomy ( 7% vs 23%; RR=0.32 ), as well as among 136 patients with a dilated pancreatic duct ( 2% vs 15%; RR=0.11 ) and 164 patients with a nondilated pancreatic duct ( 15% vs 27%; RR=0.55 ).
In conclusion, the perioperative treatment with Pasireotide has decreased the rate of clinically significant postoperative pancreatic fistula, leak, or abscess. ( Xagena )
Allen PJ et al, N Engl J Med 2014; 370:2014-2022