Morbidity and mortality in the Italian Gastric Cancer Study Group randomized clinical trial of D1 versus D2 resection for gastric cancer

Abstract

Abstract Background A randomized clinical trial was performed to compare D1 and D2 gastrectomy in specialized Western centres. This paper reports short-term results. Method A total of 267 patients with gastric cancer were randomly assigned to either a D1 or a D2 procedure in five specialized centres. Based on the findings of the phase II trial and published phase III trials, a prespecified non-inferiority boundary at 12 per cent difference between groups was set regarding total morbidity. Results In the intention-to-treat analysis, the overall morbidity rate after D2 and D1 dissections was 17·9 and 12·0 per cent respectively (P = 0·178), with a 95 per cent confidence interval of the difference of 0 to 13·0 per cent, slightly exceeding the prespecified non-inferiority limit. There was a single duodenal stump leak in the D2 arm (0·7 per cent). The postoperative 30-day mortality rate was 3·0 per cent after D1 and 2·2 per cent after D2 gastrectomy (P = 0·722). Conclusion In specialized centres the rate of complications following D2 dissection is much lower than in published randomized Western trials. D2 dissection, in an appropriate setting, can therefore be considered a safe option for the radical management of gastric cancer in Western patients. Registration number: ISRCTN11154654 (http://www.controlled-trials.com).