胆囊癌根治性目的切除术达到教科书式结局对远期预后影响的全国多中心队列研究

Influence of curative‑intent resection with textbook outcomes on long‑term prognosis of gall-bladder carcinoma: a national multicenter study

    摘要
  • 摘要:
    目的 探讨胆囊癌根治性目的切除术后达到肝脏外科中教科书式结局（TOLS）对远期预后的影响。
    方法 采用回顾性队列研究方法。收集2014年1月至2021年1月中华消化外科菁英荟胆道外科学组全国多中心数据库15家医学中心收治的824例胆囊癌患者的临床病理资料；男285例,女539例；年龄为（62±11）岁。根据TOLS评价标准,将患者分为达到TOLS和未达到TOLS。正态分布的计量资料以x±s表示,组间比较采用独立样本t检验；偏态分布的计量资料以M（Q1,Q3）表示,组间比较采用Mann‑Whitney U检验。计数资料以绝对数表示,组间比较采用χ²检验。等级资料比较采用Mann⁃Whitney U检验。采用Kaplan‑Meier法计算生存率和绘制生存曲线,Log‑rank检验进行生存分析。单因素分析和多因素分析采用COX逐步回归模型向后Wald法。
    结果 （1）TOLS情况。824例行胆囊癌根治性目的切除术患者中,510例达到TOLS,314例未达到TOLS。（2）随访情况。824例行胆囊癌根治性目的切除术患者,排除出院后90 d内死亡的112例,712例患者纳入生存分析。510例达到TOLS患者的中位随访时间为22.1（11.4,30.1）个月,中位总生存时间为47.6（30.6,64.6）个月,5年总生存率为47.5%。202例未达到TOLS患者的中位随访时间为14.0（6.8,25.5）个月,中位总生存时间为24.3（20.0,28.6）个月,5年总生存率为21.0%。两者总生存情况比较,差异有统计学意义（χ²=58.491,P<0.05）。（3）影响患者生存情况的因素分析。多因素分析结果显示：TOLS、癌胚抗原、CA19‑9、肿瘤分化程度为低分化、第八版美国癌症联合委员会（AJCC）T2期、第八版AJCC T3期和T4期、第八版AJCC N1期、第八版AJCC N2期、辅助治疗是胆囊癌根治性目的切除术后患者总生存时间的独立影响因素（风险比=0.452,1.479,1.373,1.612,1.455,1.481,1.835,1.978,0.538,95%可信区间为0.352~0.581,1.141~1.964,1.052~1.791,1.259~2.063,1.102~1.920,1.022~2.147,1.380~2.441,1.342~2.915,0.382~0.758,P<0.05）。
    结论 达到TOLS的胆囊癌根治性目的切除术患者能够获得更好的远期预后。

     

    Abstract:
    Objective To investigate the influence of curative‑intent resection with textbook outcomes of liver surgery (TOLS) on long‑term prognosis of gallbladder carcinoma (GBC).
    Methods The retrospective cohort study was conducted. The clinicopathological data of 824 patients with GBC in the national multicenter database of Biliary Surgery Group of Elite Group of Chinese Journal of Digestive Surgery, who were admitted to 15 medical centers from January 2014 to January 2021, were collected. There were 285 males and 539 females, aged (62±11)years. According to the evalua-tion criteria of TOLS, patients were divided into those who achieved TOLS and those who did not achieve TOLS. Measurement data with normal distribution were represented as Mean±SD, and com-parison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M(Q1,Q3), and comparison between groups was conducted using the Mann‑Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi‑square test. Comparison of ordinal data were conduc-ted using the Mann‑Whitney U test. The Kaplan‑Meier method was used to calculate survival rate and draw survival curve, and the Log‑rank test was used for survival analysis. The COX stepwise regression model with backward Wald method was used for univariate and multivariate analyses.
    Results (1) Achievement of TOLS. Of the 824 patients undergoing curative‑intent resection for GBC, there were 510 cases achieving TOLS and 314 cases not achieving TOLS. (2) Follow‑up. Of the 824 patients undergoing curative‑intent resection for GBC, after excluding 112 deaths within 90 days after discharge, 712 cases were included for the survival analysis. The median follow‑up time, median overall survival time and 5‑year overall survival rate of the 510 patients achieving TOLS were 22.1(11.4,30.1)months, 47.6(30.6,64.6)months and 47.5%. The median follow‑up time, median overall survival time and 5‑year overall survival rate of the 202 patients not achieving TOLS were 14.0(6.8,25.5)months, 24.3(20.0,28.6)months and 21.0%. There was a significant difference in overall survival between patients achieving TOLS and patients not achieving TOLS (χ²=58.491, P<0.05). (3) Analysis of factors influencing prognosis of patients. Results of multivariate analysis showed that TOLS, carcinoembryonic antigen (CEA), CA19‑9, poorly differentiation of tumor, T2 stage of eighth edition of American Joint Committee on Cancer (AJCC) staging, T3 and T4 stage of eighth edition of AJCC staging, N1 stage of the eighth edition of AJCC staging, N2 stage of the eighth edition of AJCC staging, adjuvant therapy were independent factors influencing overall survival time of patients undergoing curative‑intent resection for GBC (hazard ratio=0.452, 1.479, 1.373, 1.612, 1.455, 1.481, 1.835, 1.978, 0.538, 95% confidence interval as 0.352-0.581, 1.141-1.964, 1.052-1.791, 1.259-2.063, 1.102-1.920, 1.022-2.147, 1.380-2.441, 1.342-2.915, 0.382-0.758, P<0.05).
    Conclusion Patients under-going curative‑intent resection for GBC with TOLS can achieve better long‑term prognosis.

     

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