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Comment & Response
August 11, 2021

Learning From Technical Details With Effect on Postoperative Pancreatic Fistula—Reply

Author Affiliations
  • 1Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Tsurumai-cho, Showa-ku, Nagoya, Japan
  • 2Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, Sugitani, Toyama, Japan
  • 3Second Department of Surgery, Wakayama Medical University, Kimiidera, Wakayama, Japan
JAMA Surg. 2021;156(12):1183-1184. doi:10.1001/jamasurg.2021.3751

In Reply We wish to thank Cienfuegos et al for their interest in our article1 and for providing helpful and constructive comments. First of all, we acknowledge that the proportion of pancreatic fistulas (PFs; grades B/C) were very high, including biochemical leaks (grade A). We noted some of the problems and limitations of the trial in the article.1 In short, the actual PF rate in randomized clinical trials could be worse than the rates reported in observational studies, which may to some extent explain our current results. Indeed, changing the assumption of the grade B/C PF incidence rate from 10% to 27.1% reduces the power from 83.9% to 55.3%, but the difference in the PF rate was considerably smaller than the noninferiority margin, 0.09 (modified intent-to-treat set: −0.014; per-protocol set: 0.003). Therefore, this result suggests the noninferiority of combined division of the splenic vein compared with separate division of the splenic vein.

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