Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial
Mené en Chine sur 1 056 patients atteints d'un cancer gastrique de stade T2-4aN0-3M0, cet essai multicentrique compare, du point de vue de la morbidité post-opératoire et de la mortalité à 30 jours, l'intérêt de deux techniques de gastrectomie distale en combinaison avec une lymphadénectomie D2, l'une par voie laparoscopique et l'autre par voie ouverte
Purpose : The safety and efficacy of radical laparoscopic distal gastrectomy (LG) with D2 lymphadenectomy for the treatment of advanced gastric cancer (AGC) remain controversial. We conducted a randomized controlled trial to compare laparoscopic and conventional open distal gastrectomy with D2 lymph node dissections for AGC. Patients and Methods : Between September 2012 and December 2014, 1,056 patients with clinical stage T2-4aN0-3M0 gastric cancer were eligible for inclusion. They were randomly assigned to either the LG with D2 lymphadenectomy group (n = 528) or the open gastrectomy (OG) with D2 lymphadenectomy group (n = 528). Fifteen experienced surgeons from 14 institutions in China participated in the study. The morbidity and mortality within 30 days after surgery between the LG (n = 519) and the OG (n = 520) groups were compared on the basis of the modified intention-to-treat principle. Postoperative complications were stratified according to the Clavien-Dindo classification. Results : The compliance rates of D2 lymphadenectomy were similar between the LG and OG groups (99.4% v 99.6%; P = .845). The postoperative morbidity was 15.2% in the LG group and 12.9% in OG group with no significant difference (difference, 2.3%; 95% CI, –1.9 to 6.6; P = .285). The mortality rate was 0.4% for the LG group and zero for the OG group (difference, 0.4%; 95% CI, –0.4 to 1.4; P = .249). The distribution of severity was similar between the two groups (P = .314). Conclusion : Experienced surgeons can safely perform LG with D2 lymphadenectomy for AGC.