Surgical Outcomes of Laparoscopic Distal Gastrectomy with D2 Lymphadenectomy Plus Complete Mesogastric Excision (D2+CME) Versus Conventional Laparoscopic D2 Distal Gastrectomy for Locally Advanced Gastric Cancer: Short-Term Analysis of a Single Center, Prospective, Randomized Controlled Trial

Abstract

Background: Laparoscopic distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (D2+CME), proposed as a novel strategy and optional procedure in the surgical treatment of advanced gastric cancer (AGC), exhibited both surgical and oncological benefits. However, it lacks strong evidence regarding its surgical safety and oncologic efficacy. Here, we conducted a single-center, prospective, randomized controlled trial to compare laparoscopic D2+CME with conventional laparoscopic D2 lymphadenectomy for AGC. Methods: Patients aged 18 to 75 year-old with locally AGC were considered eligible. Patients were excluded due to high body mass index (>30kg/m2), combination with other tumors, preoperative chemo/radiotherapy or upper-abdominal operations history. Eligible patients were randomly (1:1) assigned to laparoscopic distal gastrectomy with D2+CME (D2+CME group) or conventional D2 lymphadenectomy (D2 group) by an independent data collecting group. The primary end-point was 3-year disease-free survival. The current interim analysis reported the surgical outcomes of the trial. Findings: Between September 2014 and June 2018, a total of 338 patients were randomly assigned to either the D2+CME or D2 group (D2+CME, 169 patients; D2, 169 patients). There were no significant differences in age, gender, ASA score or comorbidities between two groups. The postoperative complication rates of the D2+CME group and the D2 group were 20•1% (34/169) and 16•0% (27/169), respectively (p=0•322). Severe complications occurred in the 2 cases of D2 group. The mortality rate was 0% in both groups. Compared with D2 group, D2+CME group showed less intra-laparoscopic bleeding (median 15•0 [interquartile range 23•0] vs. median 37•0 [interquartile range 33•5] ml, p<0•0001) and more lymph node harvesting (median 34 [interquartile range 16] vs. median 27 [interquartile range 13], p<0•010). In the postoperative recovery course, flatus appeared earlier in the D2+CME group compared with the D2 group (p=0•009). Interpretation: Laparoscopic D2+CME exhibited advantages in intra-operative bleeding, lymph nodes harvesting and postoperative flatus duration without increasing morbidity and mortality. Thus, laparoscopic D2+CME appears safer and more effective than conventional D2 for patients with AGC. Trial Registration: This study was registered at ClinicalTrials.gov (NCT01978444). Funding Statement: This work was supported by grants from the National Science Foundation of China, Grant numbers: 81171927, 81372324, 81874185. Declaration of Interests: The authors declare no conflict of interest. Ethics Approval Statement: This trial was approved by the Ethics Committee of Huazhong University of Science and Technology.