M Degiuli1, M Sasako, A Ponti. 1. University Division of General Surgery 1a, Centro Prevenzione Oncologica Piemonte, Hospital San Giovanni Battista, Turin, Italy. mdegiuli@hotmail.com
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). Copyright 2010 British Journal of Surgery Society Ltd.
RCT Entities:
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). Copyright 2010 British Journal of Surgery Society Ltd.
Authors: Mi Ran Jung; Young Kyu Park; Jang Won Seon; Kwang Yong Kim; Oh Cheong; Seong Yeob Ryu Journal: World J Surg Date: 2012-10 Impact factor: 3.352