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Selective Perioperative Administration of Pasireotide is More Cost-Effective Than Routine Administration for Pancreatic Fistula Prophylaxis

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Journal of Gastrointestinal Surgery Aims and scope

Abstract

Background

In a randomized trial, pasireotide significantly decreased the incidence and severity of postoperative pancreatic fistula (POPF). Subsequent analyses concluded that its routine use is cost-effective. We hypothesized that selective administration of the drug to patients at high risk for POPF would be more cost-effective.

Study Design

Consecutive patients who did not receive pasireotide and underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) between July 2011 and January 2014 were distributed into groups based on their risk of POPF using a multivariate recursive partitioning regression tree analysis (RPA) of preoperative clinical factors. The costs of treating hypothetical patients in each risk group were then computed based upon actual institutional hospital costs and previously published relative risk values associated with pasireotide.

Results

Among 315 patients who underwent pancreatectomy, grade B/C POPF occurred in 64 (20%). RPA allocated patients who underwent PD into four groups with a risk for grade B/C POPF of 0, 10, 29, or 60% (P < 0.001) on the basis of diagnosis, pancreatic duct diameter, and body mass index. Patients who underwent DP were allocated to three groups with a grade B/C POPF risk of 14, 26, or 44% (P = 0.05) on the basis of pancreatic duct diameter alone. Although the routine administration of pasireotide to all 315 patients would have theoretically saved $30,892 over standard care, restriction of pasireotide to only patients at high risk for POPF would have led to a cost savings of $831,916.

Conclusion

Preoperative clinical characteristics can be used to characterize patients’ risk for POPF following pancreatectomy. Selective administration of pasireotide only to patients at high risk for grade B/C POPF may maximize the cost-efficacy of prophylactic pasireotide.

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Abbreviations

POPF:

Postoperative pancreatic fistula

AE:

Adverse events

PD:

Pancreatoduodenectomy

DP:

Distal pancreatectomy

ISGPF:

International Study Group on Pancreatic Fistula

RPA:

Recursive partitioning regression tree analysis

RR:

Relative risk

References

  1. Birkmeyer JD, Finlayson SR, Tosteson AN, et al. Effect of hospital volume on in-hospital mortality with pancreaticoduodenectomy. Surgery 1999;125:250–256.

    Article  CAS  PubMed  Google Scholar 

  2. Winter JM, Cameron JL, Campbell KA, et al. 1423 pancreaticoduodenectomies for pancreatic cancer: A single-institution experience. J Gastrointest Surg 2006;10:1199–1210; discussion 1210–1191.

    Article  PubMed  Google Scholar 

  3. Schwarz L, Bruno M, Parker NH, et al. Active Surveillance for Adverse Events Within 90 Days: The Standard for Reporting Surgical Outcomes After Pancreatectomy. Ann Surg Oncol 2015;22:3522–3529.

    Article  PubMed  Google Scholar 

  4. Gaujoux S, Cortes A, Couvelard A, et al. Fatty pancreas and increased body mass index are risk factors of pancreatic fistula after pancreaticoduodenectomy. Surgery 2010;148:15–23.

    Article  PubMed  Google Scholar 

  5. Grobmyer SR, Kooby D, Blumgart LH, et al. Novel pancreaticojejunostomy with a low rate of anastomotic failure-related complications. J Am Coll Surg 2010;210:54–59.

    Article  PubMed  Google Scholar 

  6. Fuks D, Piessen G, Huet E, et al. Life-threatening postoperative pancreatic fistula (grade C) after pancreaticoduodenectomy: incidence, prognosis, and risk factors. Am J Surg 2009;197:702–709.

    Article  PubMed  Google Scholar 

  7. Perwaiz A, Singhal D, Singh A, et al. Is isolated Roux loop pancreaticojejunostomy superior to conventional reconstruction in pancreaticoduodenectomy? HPB (Oxford) 2009;11:326–331.

    Article  Google Scholar 

  8. Rosso E, Casnedi S, Pessaux P, et al. The role of “fatty pancreas” and of BMI in the occurrence of pancreatic fistula after pancreaticoduodenectomy. J Gastrointest Surg 2009;13:1845–1851.

    Article  PubMed  Google Scholar 

  9. Pratt WB, Callery MP, Vollmer CM, Jr. Risk prediction for development of pancreatic fistula using the ISGPF classification scheme. World J Surg 2008;32:419–428.

    Article  PubMed  Google Scholar 

  10. Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery 2005;138:8–13.

    Article  PubMed  Google Scholar 

  11. Denbo JW, Orr WS, Zarzaur BL, et al. Toward defining grade C pancreatic fistula following pancreaticoduodenectomy: incidence, risk factors, management and outcome. HPB (Oxford) 2012;14:589–593.

    Article  Google Scholar 

  12. Yeo CJ, Cameron JL, Maher MM, et al. A prospective randomized trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy. Ann Surg 1995;222:580–588; discussion 588–592.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  13. Tran K, Van Eijck C, Di Carlo V, et al. Occlusion of the pancreatic duct versus pancreaticojejunostomy: a prospective randomized trial. Ann Surg 2002;236:422–428; discussion 428.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Knaebel HP, Diener MK, Wente MN, et al. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg 2005;92:539–546.

    Article  CAS  PubMed  Google Scholar 

  15. Berger AC, Howard TJ, Kennedy EP, et al. Does type of pancreaticojejunostomy after pancreaticoduodenectomy decrease rate of pancreatic fistula? A randomized, prospective, dual-institution trial. J Am Coll Surg 2009;208:738–747; discussion 747–739.

    Article  PubMed  Google Scholar 

  16. Bassi C, Falconi M, Molinari E, et al. Duct-to-mucosa versus end-to-side pancreaticojejunostomy reconstruction after pancreaticoduodenectomy: results of a prospective randomized trial. Surgery 2003;134:766–771.

    Article  PubMed  Google Scholar 

  17. Lillemoe KD, Cameron JL, Kim MP, et al. Does fibrin glue sealant decrease the rate of pancreatic fistula after pancreaticoduodenectomy? Results of a prospective randomized trial. J Gastrointest Surg 2004;8:766–772; discussion 772–764.

    Article  PubMed  Google Scholar 

  18. Winter JM, Cameron JL, Campbell KA, et al. Does pancreatic duct stenting decrease the rate of pancreatic fistula following pancreaticoduodenectomy? Results of a prospective randomized trial. J Gastrointest Surg 2006;10:1280–1290; discussion 1290.

    Article  PubMed  Google Scholar 

  19. Yeo CJ, Cameron JL, Lillemoe KD, et al. Does prophylactic octreotide decrease the rates of pancreatic fistula and other complications after pancreaticoduodenectomy? Results of a prospective randomized placebo-controlled trial. Ann Surg 2000;232:419–429.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  20. Lowy AM, Lee JE, Pisters PW, et al. Prospective, randomized trial of octreotide to prevent pancreatic fistula after pancreaticoduodenectomy for malignant disease. Ann Surg 1997;226:632–641.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  21. Buchler M, Friess H, Klempa I, et al. Role of octreotide in the prevention of postoperative complications following pancreatic resection. Am J Surg 1992;163:125–130; discussion 130–121.

    Article  CAS  PubMed  Google Scholar 

  22. Montorsi M, Zago M, Mosca F, et al. Efficacy of octreotide in the prevention of pancreatic fistula after elective pancreatic resections: a prospective, controlled, randomized clinical trial. Surgery 1995;117:26–31.

    Article  CAS  PubMed  Google Scholar 

  23. Li-Ling J, Irving M. Somatostatin and octreotide in the prevention of postoperative pancreatic complications and the treatment of enterocutaneous pancreatic fistulas: a systematic review of randomized controlled trials. Br J Surg 2001;88:190–199.

    Article  CAS  PubMed  Google Scholar 

  24. Sarr MG, Pancreatic Surgery G. The potent somatostatin analogue vapreotide does not decrease pancreas-specific complications after elective pancreatectomy: a prospective, multicenter, double-blinded, randomized, placebo-controlled trial. J Am Coll Surg 2003;196:556–564; discussion 564–555; author reply 565.

    Article  PubMed  Google Scholar 

  25. Bruns C, Lewis I, Briner U, et al. SOM230: a novel somatostatin peptidomimetic with broad somatotropin release inhibiting factor (SRIF) receptor binding and a unique antisecretory profile. Eur J Endocrinol 2002;146:707–716.

    Article  CAS  PubMed  Google Scholar 

  26. Allen PJ, Gonen M, Brennan MF, et al. Pasireotide for postoperative pancreatic fistula. N Engl J Med 2014;370:2014–2022.

    Article  PubMed  Google Scholar 

  27. Ma LW, Dominguez-Rosado I, Gennarelli RL, et al. The Cost of Postoperative Pancreatic Fistula Versus the Cost of Pasireotide: Results from a Prospective Randomized Trial. Ann Surg 2016.

  28. Abbott DE, Sutton JM, Jernigan PL, et al. Prophylactic pasireotide administration following pancreatic resection reduces cost while improving outcomes. J Surg Oncol 2016;113:784–788.

    Article  CAS  PubMed  Google Scholar 

  29. Goyert N, Eeson G, Kagedan DJ, et al. Pasireotide for the Prevention of Pancreatic Fistula Following Pancreaticoduodenectomy: A Cost-effectiveness Analysis. Ann Surg 2016.

  30. Callery MP, Pratt WB, Kent TS, et al. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg 2013;216:1–14.

    Article  PubMed  Google Scholar 

  31. Wellner UF, Kayser G, Lapshyn H, et al. A simple scoring system based on clinical factors related to pancreatic texture predicts postoperative pancreatic fistula preoperatively. HPB (Oxford) 2010;12:696–702.

    Article  Google Scholar 

  32. Greenblatt DY, Kelly KJ, Rajamanickam V, et al. Preoperative factors predict perioperative morbidity and mortality after pancreaticoduodenectomy. Ann Surg Oncol 2011;18:2126–2135.

    Article  PubMed  Google Scholar 

  33. Shubert CR, Wagie AE, Farnell MB, et al. Clinical Risk Score to Predict Pancreatic Fistula after Pancreatoduodenectomy: Independent External Validation for Open and Laparoscopic Approaches. J Am Coll Surg 2015;221:689–698.

    Article  PubMed  Google Scholar 

  34. Hwang RF, Wang H, Lara A, et al. Development of an integrated biospecimen bank and multidisciplinary clinical database for pancreatic cancer. Ann Surg Oncol 2008;15:1356–1366.

    Article  PubMed  Google Scholar 

  35. Katz MH, Wang H, Balachandran A, et al. Effect of neoadjuvant chemoradiation and surgical technique on recurrence of localized pancreatic cancer. J Gastrointest Surg 2012;16:68–78; discussion 78–69.

    Article  PubMed  Google Scholar 

  36. Piccirillo JF, Tierney RM, Costas I, et al. Prognostic importance of comorbidity in a hospital-based cancer registry. JAMA 2004;291:2441–2447.

    Article  CAS  PubMed  Google Scholar 

  37. Wente MN, Bassi C, Dervenis C, et al. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery 2007;142:761–768.

    Article  PubMed  Google Scholar 

  38. Wente MN, Veit JA, Bassi C, et al. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery 2007;142:20–25.

    Article  PubMed  Google Scholar 

  39. Pratt WB, Maithel SK, Vanounou T, et al. Clinical and economic validation of the International Study Group of Pancreatic Fistula (ISGPF) classification scheme. Ann Surg 2007;245:443–451.

    Article  PubMed  PubMed Central  Google Scholar 

  40. Daskalaki D, Butturini G, Molinari E, et al. A grading system can predict clinical and economic outcomes of pancreatic fistula after pancreaticoduodenectomy: results in 755 consecutive patients. Langenbecks Arch Surg 2011;396:91–98.

    Article  PubMed  Google Scholar 

  41. Cecka F, Jon B, Subrt Z, et al. Clinical and economic consequences of pancreatic fistula after elective pancreatic resection. Hepatobiliary Pancreat Dis Int 2013;12:533–539.

    Article  PubMed  Google Scholar 

  42. Diener MK, Seiler CM, Rossion I, et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet 2011;377:1514–1522.

    Article  PubMed  Google Scholar 

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Correspondence to Matthew H. G. Katz.

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Denbo, J.W., Slack, R.S., Bruno, M. et al. Selective Perioperative Administration of Pasireotide is More Cost-Effective Than Routine Administration for Pancreatic Fistula Prophylaxis. J Gastrointest Surg 21, 636–646 (2017). https://doi.org/10.1007/s11605-016-3340-7

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  • DOI: https://doi.org/10.1007/s11605-016-3340-7

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