胆囊癌根治术中淋巴结清扫数目与预后关系的多中心临床研究

Objective To examine the role of the number of lymph nodes examined(NLNE) on the prognosis of patients with curatively resected gallbladder carcinoma(GBC). Methods The clinicopathological data and prognosis of 401 patients with GBC who underwent radical surgery from six institutions of China from January 2013 to December 2017 were analyzed retrospectively. There were 153 males(38.2%) and 248 females(61.8%), with age of (62.0 ± 10.5) years (range: 30⁃88 years). Fifty⁃three patients(22.2%) were accompanied by jaundice. All patients underwent radical resection + regional lymphadenectomy.R0 or R1 resection was confirmed by postoperative pathological examination.The different cut⁃off values of NLNE were determined by the X⁃tile software,the optimal cut⁃off values were identified by analyzing the relationship between different cut⁃off values of NLNE with survival rate. Kaplan⁃Meier method was used for survival analysis. Univariate and multivariate analysis were implemented respectively using the Log⁃rank test and Cox proportional hazard model. Results Among the 401 patients enrolled, 135 cases (33.6%) had lymphatic metastasis,of which 98 cases were in N1 stage(24.4%) and 37 cases were in N2 stage(9.2%).A total of 2 794 NLNE were retrieved,with a median count of 6 (5).The median positive lymph nodes count was 0 (1), and the median positive lymph nodes ratio was 0 (IQR, 0-0.2). Since the 12 and 15 were determined as the cut⁃off values by X⁃tile, all patients were divided into three groups of 1-11, 12-15 and ≥16.The 3⁃year survival rate of the three groups was 45.2%,74.5%,12.0% respectively,with statistically significant difference between three groups(χ² =10.94, P<0.01). The results of multivariate analysis showed that NLNE was an independent prognostic factor for overall survival(P<0.05).Further analysis was performed specifically for subgroup of T stages. For T1b patients, the prognosis of the NLNE with 1-7 group was significantly better than that of the ≥8 group(χ^2=4.610, P<0.05).For T2 patients,the prognosis of the TLNE ≥ 7 group was significantly better than that of 1 － 6 group(χ² =4.287, P<0.05). For T3 and T4 patients, the prognosis of the TLNE with 12 － 15 group was significantly better than that of 1 -11 group(χ^2=5.007,P< 0.01) and ≥16 group(χ² =10.158, P<0.01). Conclusions The NLNE is an independent factor affecting the prognosis of patients with GBC.For patients with stage T1b,8 lymph nodes should be retrieved;for patients with stage T2,extensive dissection of more than 6 lymph nodes can significantly improve the prognosis.For advanced patients(stages T3 and T4), extensive dissection with 12-15 lymph nodes is recommended. However it fails to get more survival benefits by dissecting more than 16 lymph nodes.