A Randomized Prospective Multicenter Trial of Pancreaticoduodenectomy With and Without Routine Intraperitoneal Drainage

George Van Buren II, MD; Mark Bloomston, MD; Steven J. Hughes, MD; Jordan Winter, MD; Stephen W. Behrman, MD; Nicholas J. Zyromski, MD; Charles Vollmer, MD; Vic Velanovich, MD; Taylor Riall, MD; Peter Muscarella, MD; Jose Trevino, MD; Attila Nakeeb, MD; C. Max Schmidt, MD; Kevin Behrns, MD; E. Christopher Ellison, MD; Omar Barakat, MD; Kyle A. Perry, MD; Jeffrey Drebin, MD; Michael House, MD; Sherif Abdel-Misih, MD; Eric J. Silberfein, MD; Steven Goldin, MD; Kimberly Brown, MD; Somala Mohammed, MD; Sally E. Hodges, BS; Amy McElhany, MPH; Mehdi Issazadeh, BS; Eunji Jo, MS; Qianxing Mo, PhD; William E. Fisher, MD

Disclosures

Annals of Surgery. 2014;259(4):605-612. 

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Based on preliminary data, the study was originally designed to detect a 10% difference in the grade II or greater complication rate between the drain and no-drain groups for the patients undergoing PD and distal pancreatectomy. A total of 752 evaluable patients were needed for the 2 study groups (n = 376 per group) in order to achieve 80% power to detect a 10% increase or decrease in the complication rate with a significance level of 0.05. The primary endpoint for this study, the 60-day grade II or greater complication rate, was compared using the χ2 test. Other secondary outcomes were similarly compared between the 2 groups for categorical variables using the χ2 test or Fisher exact test as appropriate. For continuous variables, the t test or Wilcoxon rank sum test was used. P values less than 0.05 were considered statistically significant. All the P values were not adjusted for multiple comparisons because except for the comparison for the primary endpoint, all the other comparisons were secondary or exploratory, and we obtained only less than one-fifth of the patients needed for the comparisons because the trial was stopped early.

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