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Br J Surg. 2010 May;97(5):643-9. doi: 10.1002/bjs.6936.

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

Author information

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).

PMID:
20186890
DOI:
10.1002/bjs.6936
[Indexed for MEDLINE]

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