纳米炭导航行淋巴示踪在结直肠癌TNM分期中淋巴分期价值的临床研究

doi:10.3877/cma.j.issn.2095-3224.2024.04.004

目的

探索纳米炭混悬注射液在结直肠癌TNM分期中淋巴分期的临床价值。

方法

南京大学医学院附属鼓楼医院结直肠外科自2021年7月起，开展了一项前瞻性、随机对照临床试验。患者筛选合格后，随机分配到试验组和对照组，计划纳入每组可评价病例200例。试验组患者由研究者行肠镜检查，并注射纳米炭混悬液。对照组患者常规进行手术，术前不注射纳米炭混悬液。比较两组之间淋巴结检出数、阳性淋巴结检出数、淋巴分期之间的差异。

结果

共361例患者纳入临床研究，其中试验组179例，对照组182例。试验组患者获取的淋巴结总数平均为（20.2±5.9）枚，高于对照组的（15.0±5.5）枚，差异有统计学意义（t=8.584，P<0.001）。试验组患者获取的阳性淋巴结总数平均为（1.6±3.9）枚，高于对照组的（0.8±1.9）枚，差异有统计学意义（t=2.852，P=0.005）。试验组中，97例患者（54.2%）淋巴分期为N0，56例患者（31.3%）为N1，26例患者（14.5%）为N2。对照组中，115例患者（63.2%）淋巴分期为N0，57例患者（31.3%）为N1，10例患者（5.5%）为N2。两组之间淋巴分期的差异有统计学意义（χ²=8.624，P=0.013）。

结论

结直肠癌行纳米炭淋巴示踪导航可以获取更多的淋巴结和阳性淋巴结，从而得到更精准、更客观的淋巴分期，判断预后，指导后续治疗方案。

关键词: 结直肠肿瘤, 纳米炭, 淋巴示踪, 淋巴分期, 导航

Objective

To explore the clinical value of carbon nanocomposite suspension injection in TNM staging of colorectal cancer.

Methods

A prospective, randomized, controlled clinical trial was conducted in July 2021 in the Department of Colorectal Surgery, Nanjing Drum Tower Hospital. After the patients were qualified, they were randomly assigned to study group and control group, and 200 evaluable cases were planned to be included in each group. The patients in the study group underwent colonoscopy and were injected with carbon nanocomposite suspension. The patients in the control group were treated with routine operation, and no carbon nano-suspension was injected before operation. The number of lymph nodes detected, the number of positive lymph nodes detected and the lymph stages were compared between the two groups.

Results

A total of 361 patients were enrolled in the clinical study, including 179 patients in the study group and 182 patients in the control group. The total number of lymph nodes obtained in the study group was 20.2±5.9, which was significantly higher than that in the control group (15.0±5.5) (t=8.584, P<0.001). The total number of positive lymph nodes in the study group was 1.6±3.9, which was significantly higher than that in the control group (0.8±1.9)(t=2.852, P=0.005). In the study group, 97 patients (54.2%) were N0, 56 patients (31.3%) were N1, and 26 patients (14.5%) were N2. In the control group, 115 patients (63.2%) were N0, 57 patients (31.3%) were N1, and 10 patients (5.5%) were N2. There was significant difference in lymph staging between the two groups (χ²=8.624, P=0.013).

Conclusion

The application of nano-carbon in lymph node tracing navigation for colorectal cancer can obtain more lymph nodes and positive lymph nodes, and thus obtain more accurate and objective lymph node staging, judge prognosis and guide follow-up treatment plan.

Key words: Colorectal neoplasms, Carbon nanoparticles, Lymphatic tracing, Lymphatic staging, Navigation

表1 入组患者的一般临床参数

变量	试验组（n=179）	对照组（n=182）	t/χ²值	P值
年龄（岁）	62.9±10.5	63.2±10.7	0.193	0.847
性别			0.045	0.913
男	116	116
女	63	66
诊断			2.92	0.102
乙状结肠癌	39	27
直肠癌	140	155
手术方式			0.163	0.722
腹腔镜	175	179
开放	4	3
肿瘤最大径（cm）	3.31±0.99	3.67±1.11	0.878	0.380
术中标本切除的长度（cm）	15.1±2.2	15.5±2.2	1.193	0.234
T分期			2.037	0.361
T1	37	49
T2	109	100
T3	33	33
手术时间（分钟）	175±18	170±19	-0.190	0.849
出血量（mL）	83±34	80±38	-0.924	0.357
住院时间（天）	11.8±1.7	12.0±1.9	-0.130	0.886

表1 入组患者的一般临床参数

变量	试验组（n=179）	对照组（n=182）	t/χ²值	P值
年龄（岁）	62.9±10.5	63.2±10.7	0.193	0.847
性别			0.045	0.913
男	116	116
女	63	66
诊断			2.92	0.102
乙状结肠癌	39	27
直肠癌	140	155
手术方式			0.163	0.722
腹腔镜	175	179
开放	4	3
肿瘤最大径（cm）	3.31±0.99	3.67±1.11	0.878	0.380
术中标本切除的长度（cm）	15.1±2.2	15.5±2.2	1.193	0.234
T分期			2.037	0.361
T1	37	49
T2	109	100
T3	33	33
手术时间（分钟）	175±18	170±19	-0.190	0.849
出血量（mL）	83±34	80±38	-0.924	0.357
住院时间（天）	11.8±1.7	12.0±1.9	-0.130	0.886

图1 肠系膜内可见黑染的淋巴结

表2 试验组与对照组获取的淋巴结总数的比较（

）

分类	试验组	对照组	t值	P值
淋巴结获取的总数	20.2±5.9	15.0±5.5	8.584	<0.001
阳性淋巴结获取总数	1.6±3.9	0.8±1.9	2.852	0.005
253组淋巴结获取的总数	2.2±3.0	1.6±2.0	2.475	0.014
阳性253组淋巴结获取总数	0.07±0.49	0.00±0.00	2.106	0.045

表2 试验组与对照组获取的淋巴结总数的比较（

）

分类	试验组	对照组	t值	P值
淋巴结获取的总数	20.2±5.9	15.0±5.5	8.584	<0.001
阳性淋巴结获取总数	1.6±3.9	0.8±1.9	2.852	0.005
253组淋巴结获取的总数	2.2±3.0	1.6±2.0	2.475	0.014
阳性253组淋巴结获取总数	0.07±0.49	0.00±0.00	2.106	0.045

表3 两组之间淋巴分期及TNM分期的比较[例（%）]

分期	试验组（n=179）	对照组（n=182）	χ²值	P值
N分期			8.624	0.013
N0	97（54.2）	115（63.2）
N1	56（31.3）	57（31.3）
N2	26（14.5）	10（5.5）
TNM分期			6.340	0.042
Ⅰ	38（21.2）	58（31.9）
Ⅱ	58（32.4）	59（32.4）
Ⅲ	83（46.4）	65（35.7）

表3 两组之间淋巴分期及TNM分期的比较[例（%）]

分期	试验组（n=179）	对照组（n=182）	χ²值	P值
N分期			8.624	0.013
N0	97（54.2）	115（63.2）
N1	56（31.3）	57（31.3）
N2	26（14.5）	10（5.5）
TNM分期			6.340	0.042
Ⅰ	38（21.2）	58（31.9）
Ⅱ	58（32.4）	59（32.4）
Ⅲ	83（46.4）	65（35.7）

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Clinical research on the value of carbon nanoparticles navigation lymphatic tracing in TNM staging of colorectal cancer

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Clinical research on the value of carbon nanoparticles navigation lymphatic tracing in TNM staging of colorectal cancer