Pasireotide for postoperative pancreatic fistula Journal Article


Authors: Allen, P. J.; Gonen, M.; Brennan, M. F.; Bucknor, A. A.; Robinson, L. M.; Pappas, M. M.; Carlucci, K. E.; D'Angelica, M. I.; DeMatteo, R. P.; Kingham, T. P.; Fong, Y.; Jarnagin, W. R.
Article Title: Pasireotide for postoperative pancreatic fistula
Abstract: BACKGROUND: Postoperative pancreatic fistula is a major contributor to complications and death associated with pancreatic resection. Pasireotide, 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. METHODS: We conducted a single-center, randomized, double-blind trial of perioperative subcutaneous pasireotide in patients undergoing either pancreaticoduodenectomy or distal pancreatectomy. We randomly assigned 300 patients to receive 900 μg 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). RESULTS: 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, 0.44; 95% confidence interval [CI], 0.24 to 0.78; P=0.006). This finding was consistent among 220 patients who underwent pancreaticoduodenectomy (10% vs. 21%; relative risk, 0.49; 95% CI, 0.25 to 0.95) and 80 patients who underwent distal pancreatectomy (7% vs. 23%; relative risk, 0.32; 95% CI, 0.10 to 0.99), as well as among 136 patients with a dilated pancreatic duct (2% vs. 15%; relative risk, 0.11; 95% CI, 0.02 to 0.60) and 164 patients with a nondilated pancreatic duct (15% vs. 27%; relative risk, 0.55; 95% CI, 0.29 to 1.01). CONCLUSIONS: Perioperative treatment with pasireotide decreased the rate of clinically significant postoperative pancreatic fistula, leak, or abscess. Copyright © 2014 Massachusetts Medical Society.
Journal Title: New England Journal of Medicine
Volume: 370
Issue: 21
ISSN: 0028-4793
Publisher: Massachusetts Medical Society  
Date Published: 2014-05-22
Start Page: 2014
End Page: 2022
Language: English
DOI: 10.1056/NEJMoa1313688
PROVIDER: scopus
PUBMED: 24849084
DOI/URL:
Notes: New Engl. J. Med. -- Export Date: 2 June 2014 -- CODEN: NEJMA -- Source: Scopus
Altmetric
Citation Impact
MSK Authors
  1. Murray F Brennan
    1027 Brennan
  2. Ronald P DeMatteo
    636 DeMatteo
  3. Mithat Gonen
    884 Gonen
  4. Peter Allen
    499 Allen
  5. William R Jarnagin
    740 Jarnagin
  6. Yuman Fong
    771 Fong
  7. T Peter Kingham
    430 Kingham
  8. Marisa Margaret Pappas
    3 Pappas