Background: The disadvantages of D2 gastrectomy have been mostly related to splenopancreatectomy. Unlike two large European trials, we have recently showed the safety of D2 dissection with pancreas preservation in a one-arm phase I-II trial. This new randomised trial was set up to compare post-operative morbidity and mortality and survival after D1 and D2 gastrectomy among the same experienced centres that participated into the previous trial.
Methods: In a prospective multicenter randomised trial, D1 gastrectomy was compared to D2 gastrectomy. Central randomisation was performed following a staging laparotomy in 162 patients with potentially curable gastric cancer.
Findings: Of 162 patients randomised, 76 were allocated to D1 and 86 to D2 gastrectomy. The two groups were comparable for age, sex, site, TNM stage of tumours, and type of resection performed. The overall post-operative morbidity rate was 13.6%. Complications developed in 10.5% of patients after D1 and in 16.3% of patients after D2 gastrectomy. This difference was not statistically significant (p<0.29). Reoperation rate was 3.4% after D2 and 2.6% after D1 resection. Post-operative mortality rate was 0.6% (one death); it was 1.3% after D1 and 0% after D2 gastrectomy.
Interpretation: Our preliminary data confirm that in very experienced centres morbidity and mortality after extended gastrectomy can be as low as those showed by Japanese authors. They also suggest that D2 gastrectomies with pancreas preservation are not followed by significantly higher morbidity and mortality than D1 resections.