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Pasireotide for postoperative pancreatic fistula.

Publication ,  Journal Article
Allen, PJ; Gönen, M; Brennan, MF; Bucknor, AA; Robinson, LM; Pappas, MM; Carlucci, KE; D'Angelica, MI; DeMatteo, RP; Kingham, TP; Fong, Y ...
Published in: N Engl J Med
May 22, 2014

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. (Funded by Novartis Pharmaceuticals; ClinicalTrials.gov number, NCT00994110.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 22, 2014

Volume

370

Issue

21

Start / End Page

2014 / 2022

Location

United States

Related Subject Headings

  • Somatostatin
  • Postoperative Complications
  • Perioperative Period
  • Pancreaticoduodenectomy
  • Pancreatic Fistula
  • Pancreatic Ducts
  • Pancreatectomy
  • Middle Aged
  • Male
  • Injections, Subcutaneous
 

Citation

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Allen, P. J., Gönen, M., Brennan, M. F., Bucknor, A. A., Robinson, L. M., Pappas, M. M., … Jarnagin, W. R. (2014). Pasireotide for postoperative pancreatic fistula. N Engl J Med, 370(21), 2014–2022. https://doi.org/10.1056/NEJMoa1313688
Allen, Peter J., Mithat Gönen, Murray F. Brennan, Adjoa A. Bucknor, Lindsay M. Robinson, Marisa M. Pappas, Kate E. Carlucci, et al. “Pasireotide for postoperative pancreatic fistula.N Engl J Med 370, no. 21 (May 22, 2014): 2014–22. https://doi.org/10.1056/NEJMoa1313688.
Allen PJ, Gönen M, Brennan MF, Bucknor AA, Robinson LM, Pappas MM, et al. Pasireotide for postoperative pancreatic fistula. N Engl J Med. 2014 May 22;370(21):2014–22.
Allen, Peter J., et al. “Pasireotide for postoperative pancreatic fistula.N Engl J Med, vol. 370, no. 21, May 2014, pp. 2014–22. Pubmed, doi:10.1056/NEJMoa1313688.
Allen PJ, Gönen M, Brennan MF, Bucknor AA, Robinson LM, Pappas MM, Carlucci KE, D’Angelica MI, DeMatteo RP, Kingham TP, Fong Y, Jarnagin WR. Pasireotide for postoperative pancreatic fistula. N Engl J Med. 2014 May 22;370(21):2014–2022.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 22, 2014

Volume

370

Issue

21

Start / End Page

2014 / 2022

Location

United States

Related Subject Headings

  • Somatostatin
  • Postoperative Complications
  • Perioperative Period
  • Pancreaticoduodenectomy
  • Pancreatic Fistula
  • Pancreatic Ducts
  • Pancreatectomy
  • Middle Aged
  • Male
  • Injections, Subcutaneous