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Comment & Response
July 15, 2020

The Hydrocortisone vs Pasireotide in Reducing Pancreatic Surgery Complications Noninferiority Trial: Comparing Apples and Pears?

Author Affiliations
  • 1Department of Hepatobiliary and Pancreatic Surgery, Nottingham Digestive Diseases Centre and National Institute for Health Research Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Queen’s Medical Centre, Nottingham, England
JAMA Surg. 2020;155(10):994-995. doi:10.1001/jamasurg.2020.1998

To the Editor We read with interest the noninferiority randomized clinical trial (RCT) by Tarvainen et al1 comparing Hydrocortisone vs Pasireotide in Reducing Pancreatic Surgery Complications (HYPAR). Somatostatin analogues have been advocated in the prophylactic setting to reduce the risk of postoperative pancreatic fistula (POPF). Therefore, any trial that was designed to test the noninferiority of a newer treatment against a somatostatin analogue should have been powered on this outcome. Additionally, per protocol analysis that includes all patients who satisfactorily complied with treatment are usually preferred in noninferiority trials because it is more likely to clearly detect any treatment differences. At the very least, this should be reported alongside the intention-to-treat analysis.2

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