Safety and Feasibility of Laparoscopic Spleen-Preserving Splenic Hilar Lymphadenectomy During Total Gastrectomy for Advanced Proximal Gastric Cancer: A Randomized Clinical Trial

Abstract

Background: The splenic hilar lymph node (No. 10 LN) dissection is still controversial for patients with advanced proximal gastric cancer (APGC) not invading the greater curvature. The present study aimed to evaluate the short-term outcomes of laparoscopic spleen-preserving No. 10 lymphadenectomy (LSPL) for APGC not invading the greater curvature and the characteristic of No. 10 LN metastasis. Methods: This single-center, open-label, randomized, phase III clinical trial was done in the Department of Gastric Surgery, Fujian Medical University Union Hospital (FMUUH). Individuals aged 18 to 75 years who had histologically proven gastric adenocarcinoma in proximal stomach with clinical stage cT2-4a/N0-3/M0 not invading the greater curvature were enrolled and randomized (1:1) to receive laparoscopy-assisted total gastrectomy with either D2 lymphadenectomy (D2 group) or D2 lymphadenectomy without No. 10 LN dissection (D2- group). The main outcomes were morbidity and mortality within 30 days after surgery, number of retrieved LNs, and the metastasis rate of No. 10 LN. Analysis was based on modified intention-to-treat. Findings: From Jan 5, 2015, to Dec 10, 2018, 268 participants were randomly assigned to the D2 and D2- groups respectively. The full analysis set consisted of 263 participants in the D2 and D2- groups respectively. There were no significant differences in the intraoperative and postoperative morbidity between the D2 and D2- groups (all P>0.05). And there was no mortality in either group. There were more retrieved LNs in the D2 group than in the D2- group (45.1 vs 40.6, P=0.001). The metastasis rate of the No. 10 LN was 13.3% (35/263): 4.9% (2/41) in the early stage, and 14.9% (18/223) in the advanced stage. Pathological T (pT) stage and pN stage were related to No. 10 LN metastasis. The metastasis rates of No. 10 LN in T3-4a tumors located in the lesser curvature, posterior wall or multiple parts were all higher than 10%. Interpretation: Experienced surgeons can safely perform LSPL for APGC with more retrieved LNs. For APGC located in the lesser curvature, posterior wall or multiple parts with a clinical stage cT3-4a, dissection of the No.10 LN is necessary. Trial Registration: The study is registered with ClinicalTrials.gov, number NCT02333721; the trial has ended and this report represents the final analysis. Funding Statement: This study was supported by Scientific and Technological Innovation Joint Capital Projects of Fujian Province (2016Y9031; 2017Y9011). Construction Project of Fujian Province Minimally Invasive Medical Center (No. [2017]171). Fujian Science and Technology Innovation Joint Fund Project (2017Y9004). Joint Funds for the Innovation of Science and Technology of Fujian Province (2018Y9041). Special Fund for Clinical Research of Wu Jieping Medical Foundation (No: 320.6750.17511). Declaration of Interests: There are no conflicts of interest or financial ties to disclose from any authors. Ethics Approval Statement: The trial protocol was approved by the FMUUH Ethics Committee, and all participants provided written informed consent.