纳米碳淋巴结示踪技术在胆囊癌根治术中应用价值的前瞻性研究

Application value of nano carbon lymph tracing technique in the radical resection of gallbladder cancer: a prospective study

  • 摘要: 目的:探讨纳米碳淋巴结示踪技术在胆囊癌根治术中的应用价值。
    方法:采用前瞻性研究方法。选取2010年1月至2014年12月河南省人民医院收治的120例胆囊癌患者的临床资料。采用随机数字表法将患者分为观察组和对照组。观察组患者应用纳米碳淋巴结示踪技术精准指导手术操作,在胆囊壁浆膜下4~6点注射纳米碳注射液,每点0.1 mL,15 min后行胆囊癌根治术,术中根据淋巴结黑染情况行淋巴结清扫。对照组行常规胆囊癌根治术。观察指标:(1)术中及术后情况。(2)检获淋巴结数目。(3)随访情况。采用电话方式进行随访,了解患者生存情况。随访时间截至2016年1月。正态分布的计量资料以±s表示,组间比较采用t检验。偏态分布的计量资料以M(P25,P75)表示,组间比较采用Mann-Whitney秩和检验。计数资料比较采用X2检验。等级资料比较采用非参数检验。采用Kaplan-Meier法绘制生存曲线,采用Log-rank检验进行生存分析。
    结果:筛选出符合研究条件的患者120例,观察组和对照组各60例。(1)两组患者术中及术后情况比较:观察组患者手术时间、术中出血量、术后住院时间分别为(164±51)min、(200±98)mL、(13±4)d,对照组分别为(178±52)min、(225±98)mL、(14±5)d,两组上述指标比较,差异均无统计学意义(t=-1.50,-1.42,-1.03,P>0.05)。(2)两组患者淋巴结检获数目比较:观察组患者总体淋巴结检获数目、总体阳性淋巴结检获数目、N2站淋巴结检获数目、N2站阳性淋巴结检获数目分别为13.0枚(12.0枚,15.0枚)、8.0枚(5.0枚,9.0枚)、7.0枚(5.0枚,8.0枚)、3.0枚(2.0枚,4.0枚),对照组分别为10.0枚(8.0枚,12.0枚)、5.0枚(4.0枚,6.0枚)、5.0枚(3.0枚,5.0枚)、1.0枚(1.0枚,2.0枚),两组上述指标比较,差异均有统计学意义(Z=-5.51,-4.37,-6.24,-6.18,P<0.05)。观察组患者N1站淋巴结检获数目和N1站阳性淋巴结检获数目分别为6.0枚(5.0枚,6.0枚)、4.0枚(3.0枚,5.0枚),对照组分别为6.0枚(4.0枚,7.0枚)、4.0枚(2.0枚,5.0枚),两组上述指标比较,差异均无统计学意义(Z=-0.82,-1.34,P>0.05)。观察组TNM分期Ⅱ期胆囊癌患者总体淋巴结检获数目、总体阳性淋巴结检获数目、N2站淋巴结检获数目、N2站阳性淋巴结检获数目分别为5.0枚(4.8枚,6.3枚)、0(0,0.8枚)、2.0枚(1.0枚,3.3枚)、0(0,0.5枚),对照组分别为3.0枚(2.0枚,4.3枚)、0(0,0)、0(0,1.3枚)、0(0,0),两组上述指标比较,差异均有统计学意义(Z=-2.96,-2.02,-2.38,-2.01,P<0.05)。观察组TNM分期Ⅱ期胆囊癌患者N1站淋巴结检获数目和N1站阳性淋巴结检获数目为3.0枚(3.0枚,3.3枚)、0(0,0.3枚),对照组分别为3.0枚(2.0枚,3.0枚)、0(0,0),两组上述指标比较,差异均无统计学意义(Z=-1.18,-1.81,P>0.05)。观察组TNM分期Ⅲ期胆囊癌患者总体淋巴结检获数目、总体阳性淋巴结检获数目、N2站淋巴结检获数目、N2站阳性淋巴结检获数目分别为13.0枚(12.0枚,15.0枚)、7.0枚(5.0枚,8.0枚)、7.0枚(5.0枚,8.0枚)、3.0枚(2.0枚,4.0枚),对照组分别为10.0枚(9.0枚,12.0枚)、5.0枚(4.0枚,6.0枚)、5.0枚(4.0枚,5.0枚)、2.0枚(1.0枚,2.0枚),两组上述指标比较,差异均有统计学意义(Z=-4.80,-3.43,-5.25,-4.76,P<0.05)。观察组TNM分期Ⅲ期胆囊癌患者N1站淋巴结检获数目和N1站阳性淋巴结检获数目分别为6.0枚(6.0枚,8.0枚)、4.0枚(3.0枚,5.0枚),对照组分别为6.0枚(5.0枚,7.0枚)、4.0枚(3.0枚,4.5枚),两组上述指标比较,差异均无统计学意义(Z=-1.52,-1.16,P>0.05)。观察组TNM分期Ⅳa期胆囊癌患者总体淋巴结检获数目、总体阳性淋巴结检获数目、N2站淋巴结检获数目、N2站阳性淋巴结检获数目分别为14.0枚(13.0枚,15.0枚)、9.0枚(8.0枚,10.0枚)、8.0枚(7.5枚,8.0枚)、4.0枚(4.0枚,5.0枚),对照组分别为11.0枚(10.0枚,13.0枚)、6.0枚(4.0枚,8.0枚)、5.0枚(5.0枚,6.0枚)、2.0枚(1.0枚,2.0枚),两组上述指标比较,差异均有统计学意义(Z=-3.47,-3.25,-4.02,-3.92,P<0.05)。观察组TNM分期Ⅳa期胆囊癌患者N1站淋巴结检获数目和N1站阳性淋巴结检获数目分别为6.0枚(5.5枚,6.0枚)、5.0枚(4.0枚,5.0枚),对照组分别为6.0枚(5.0枚,7.0枚)、4.0枚(3.0枚,6.0枚),两组上述指标比较,差异均无统计学意义(Z=-0.14,-0.45,P>0.05)。(3)随访情况:120例患者均获得随访,随访时间为12~60个月,中位随访时间为28个月。观察组和对照组胆囊癌患者术后总体生存时间分别为(45.7±2.3)个月和(36.5±2.4)个月,两组生存情况比较,差异有统计学意义(X2=8.32,P<0.05)。观察组和对照组TNM分期Ⅱ期胆囊癌患者术后总体生存时间分别为(54.5±3.0)个月和(39.6±0.9)个月,两组生存情况比较,差异无统计学意义(X2=3.77,P>0.05)。观察组和对照组TNM分期Ⅲ期胆囊癌患者术后总体生存时间分别为(42.2±2.7)个月和(35.0±3.0)个月,两组生存情况比较,差异有统计学意义(X2=4.12,P<0.05)。观察组和对照组TNM分期Ⅳa期胆囊癌患者术后总体生存时间分别为(37.7±2.5)个月和(27.0±3.1)个月,两组生存情况比较,差异有统计学意义(X2=4.14,P<0.05)。
    结论:胆囊癌根治术中应用纳米碳淋巴结示踪技术能指导精准手术操作,提高总体及阳性淋巴结检获数目,延长患者术后总体生存时间。

     

    Abstract: Objective:To explore the application value of nano carbon lymph tracing technique in the radical resection of gallbladder cancer.
    Methods:The prospective study was conducted. The clinical data of 120 patients with gallbladder cancer who were admitted to the Henan Provincial People′s Hospital between January 2010 and December 2014 were collected. All the patients were allocated into the experimental group and control group by random number table. For the experimental group, a total of 0.1 mL carbon nanoparticles were injected at 4-6 locations subserously around the cancerous site, radical resection of gallbladder cancer were performed at 15 minutes after injection, and intraoperative stained lymph nodes were used as markers to guide lymphadenectomy. Patients in the control group underwent regular radical resection of gallbladder cancer. Observation indicators: (1) intra- and post- operative situations; (2) number of lymph node sorting; (3) follow-up situations. Follow-up using telephone interview was performed to detect survival of patients up to January 2016. Measurement data with normal distribution were represented as ±s and comparison between groups was analyzed using the t test. Measurement data with skewed distribution were described as M(P25, P75), and comparison between groups was analyzed by the Mann-whitney rank-sum test. Comparisons of count data were analyzed using the chi-square test. Comparison of ordinal data were analyzed by the nonparametric test. The survival curve was drawn by the Kaplan-Meier method. Survival analysis was done using the Log-rank test.
    Results: One hundred and twenty patients were screened for eligibility, and were allocated into the experimental group and control group, 60 in each group. (1) Intra- and postoperative situations: operation time, volume of intraoperative blood loss and duration of postoperative hospital stay were respectively (164±51)minutes, (200±98)mL, (13±4)days in the experimental group and (178±52)minutes, (225±98)mL,(14±5)days in the control group, with no statistically significant difference between groups (t=-1.50, -1.42, -1.03, P>0.05). (2) Comparison of lymph node sorting: overall number of lymph node sorting, overall number of positive lymph node sorting, number of N2 station lymph node sorting and number of positive N2 station lymph node sorting were respectively 13.0 (12.0, 15.0), 8.0 (5.0, 9.0), 7.0 (5.0, 8.0), 3.0 (2.0, 4.0) in the experimental group and 10.0 (8.0, 12.0), 5.0 (4.0, 6.0), 5.0 (3.0, 5.0), 1.0 (1.0, 2.0) in the control group, with statistically significant differences between groups (Z=-5.51, -4.37, -6.24, -6.18, P<0.05). Number of N1 station lymph node sorting and number of positive N1 station lymph node sorting were respectively 6.0 (5.0, 6.0), 4.0 (3.0, 5.0) in the experimental group and 6.0 (4.0, 7.0), 4.0 (2.0, 5.0) in the control group, with no statistically significant difference between groups (Z=-0.82, -1.34, P>0.05). Overall number of lymph node sorting, overall number of positive lymph node sorting, number of N2 station lymph node sorting and number of positive N2 station lymph node sorting were respectively 5.0 (4.8, 6.3), 0(0, 0.8), 2.0 (1.0, 3.3), 0(0, 0.5) in patients with stage Ⅱ of the experimental group and 3.0 (2.0, 4.3), 0 (0, 0), 0 (0, 1.3), 0(0, 0) in patients with stage Ⅱ of the control group, with statistically significant differences between groups (Z=-2.96, -2.02, -2.38, -2.01, P<0.05). Number of N1 station lymph node sorting and number of positive N1 station lymph node sorting were respectively 3.0 (3.0, 3.3), 0 (0, 0.3) in patients with stage Ⅱ of the experimental group and 3.0 (2.0, 3.0), 0 (0, 0) in patients with stage Ⅱ of the control group, with no statistically significant difference between groups (Z=-1.18, -1.81, P>0.05). Overall number of lymph node sorting, overall number of positive lymph node sorting, number of N2 station lymph node sorting and number of positive N2 station lymph node sorting were respectively 13.0 (12.0, 15.0), 7.0 (5.0, 8.0), 7.0 (5.0, 8.0), 3.0 (2.0, 4.0) in patients with stage Ⅲ of the experimental group and 10.0 (9.0, 12.0), 5.0 (4.0, 6.0), 5.0 (4.0, 5.0), 2.0 (1.0, 2.0) in patients with stage Ⅲ of the control group, with statistically significant differences between groups (Z=-4.80, -3.43, -5.25, -4.76, P<0.05). Number of N1 station lymph node sorting and number of positive N1 station lymph node sorting were respectively 6.0 (6.0, 8.0), 4.0 (3.0, 5.0) in patients with stage Ⅲ of the experimental group and 6.0 (5.0, 7.0), 4.0 (3.0, 4.5) in patients with stage Ⅲ of the control group, with no statistically significant difference between groups (Z=-1.52, -1.16, P>0.05). Overall number of lymph node sorting, overall number of positive lymph node sorting, number of N2 station lymph node sorting and number of positive N2 station lymph node sorting were respectively 14.0 (13.0, 15.0), 9.0 (8.0, 10.0), 8.0 (7.5, 8.0), 4.0 (4.0, 5.0) in patients with stage Ⅳa of the experimental group and 11.0 (10.0, 13.0), 6.0 (4.0, 8.0), 5.0 (5.0, 6.0), 2.0 (1.0, 2.0) in patients with stage Ⅳa of the control group, with statistically significant differences between groups (Z=-3.47, -3.25, -4.02, -3.92, P<0.05). Number of N1 station lymph node sorting and number of positive N1 station lymph node sorting were respectively 6.0 (5.5, 6.0), 5.0 (4.0, 5.0) in patients with stage Ⅳa of the experimental group and 6.0 (5.0, 7.0), 4.0 (3.0, 6.0) in patients with stage Ⅳa of the control group, with no statistically significant difference between groups (Z=-0.14, -0.45, P>0.05). (3) Follow-up situations: 120 patients were followed up for 12-60 months, with a median time of 28 months. The postoperative overall survival time was (45.7±2.3)months in the experimental group and (36.5±2.4)months in the control group, with a statistically significant difference between groups (X2=8.32, P<0.05). The postoperative overall survival time was (54.5±3.0) months in patients with stage Ⅱ of the experimental group and (39.6±0.9)months in patients with stage Ⅱ of the control group, with no statistically significant difference between groups (X2=3.77, P>0.05). The postoperative overall survival time was (42.2±2.7)months in patients with stage Ⅲ of the experimental group and (35.0±3.0)months in patients with stage Ⅲ of the control group, with a statistically significant difference between groups (X2=4.12, P<0.05). The postoperative overall survival time was (37.7±2.5)months in patients with stage Ⅳa of the experimental group and (27.0±3.1)months in patients with stage Ⅳa of the control group, with a statistically significant difference between groups (X2=4.14, P<0.05).
    Conclusion:The nano carbon lymph tracing technique in the radical resection of gallbladder cancer can guide precise operation, increase the numbers of overall and positive lymph nodes sorting, and extend postoperative overall survival time.

     

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