title: Morbidity and mortality in the Italian Gastric Cancer Study Group randomized clinical trial of D1 versus D2 resection for gastric cancer.
abstract: BACKGROUND
  A randomized clinical trial was performed to compare D1 and D2 gastrectomy in specialized Western centres. This paper reports short-term results.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN11154654 (http://www.controlled-trials.com).
authors.affiliation: University Division of General Surgery 1a, Centro Prevenzione Oncologica Piemonte, Hospital San Giovanni Battista, Turin, Italy. mdegiuli@hotmail.com
authors.forename: M
authors.initials: M
authors.lastname: Degiuli
authors.forename: M
authors.initials: M
authors.lastname: Sasako
authors.forename: A
authors.initials: A
authors.lastname: Ponti
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005743:Gastrectomy / Q000379:methods* / Q000401:mortality; D017052:Hospital Mortality; D006801:Humans; D007558:Italy / Q000453:epidemiology; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology* / Q000401:mortality; D013274:Stomach Neoplasms / Q000401:mortality / Q000601:surgery*