| Background.Our previously study has demonstrated the surgical advantages of D2 lymphadenectomy plus complete mesogastric excision(D2+CME)in gastric cancer surgery.To further verify the safety of D2+CME procedure,we conducted a large-scale,observational cohort study and applied propensity score matching(PSM)approach to compare D2+CME with conventional D2 in terms of short-term outcomes in gastric cancer patients.Furthermore,for DCGC(D2 plus CME for gastric cancer)01,which was a strict,single-blind,single-center,prospective,phase 2 randomized clinical trial(RCT),based on the follow-up of 3 years,the difference of oncological outcomes between D2+CME and D2 was assessed.Methods.For the PSM analysis,data on 855 patients from Tongji Hospital who underwent laparoscopic-assisted distal gastrectomy(LADG)with R0 resection(496 in the conventional D2 cohort and 359 in the D2+CME cohort)between Dec 12,2013 and Dec28,2017 were retrieved from prospectively maintained clinical database.After PSM analysis at a 1:1 ratio,each cohort included 219-matched patients.Short-term outcomes,including surgical results,morbidity,and mortality within 30 days after the operation,were collected and analyzed.For DCGC 01,which rigorously followed the criterion of one RCT and focused on patients with expectant locally advanced gastric cancer(c T2-4a N0-3M0)located at middle or distal stomach,the primary endpoint was 3-year disease-free survival,followed by secondary endpoints such as 3-year overall survival and recurrence status.Results.For the PSM analysis,the D2+CME procedure showed less intra-laparoscopic blood loss(D2 30.0±33.0 ml vs D2+CME 17.0±26.0 ml,P=0.000),more lymph node harvest(D2 22.0±16.0 vs D2+CME 27.0±17.0,P=0.000)and faster postoperative flatus than the conventional D2 procedure.However,both the overall and severe postoperative adverse events(Clavein-Dindo classification grade≥ III a)seemed comparable between two cohorts.For DCGC 01,At the follow-up point of 3 years,the 3-year disease-free survival of D2+CME group was 83.4% compared with 75.1% in D2 group,which is the primary endpoint;the significant statistical difference was observed between the two groups(P=0.0348),indicating D2+CME procedure had better oncological outcomes than that of D2 procedure.For 3-year overall survival,even though D2+CME group showed obvious advantages over D2 group,the statistical difference failed to be significant(P=0.0565).Based on follow-up of 3 years,there were some subjects undergoing tumor recurrence in both groups,25/169(14.8%)in the D2+CME group and 41/169(24.3%)in the D2 group(P=0.028).For both pathological stage I(p T2N0M0)and II(p T2N1M0,p T2N2M0,p T3N0M0,p T3N1M0 and p T4 a N0M0),there was no significant statistical difference between the two groups(P>0.05);for pathological stage III(p T3N2M0,p T3N3M0,p T4 a N1M0,p T4 a N2M0,p T4 a N3M0),D2+CME group showed significant superiority in both 3-year disease-free survival(P=0.0355)and 3-year overall survival(P=0.0312).Conclusions.The present study demonstrated that D2+CME procedure showed superiority over conventional D2 procedure in both surgical outcomes and oncological outcomes,indicating that D2+CME procedure is a probably better procedure than D2. |
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