Gastrointestinal Center, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China.
Department of Gastroenterology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China.
Sci Rep. 2021 May 11;11(1):9933. doi: 10.1038/s41598-021-89541-5.
This study aimed to evaluate whether carbon nanoparticles could improve the accuracy of nodal staging in colorectal cancer (CRC). We performed a randomized controlled trial with CRC at the department of general surgery, the affiliated hospital of Nanjing University Medical School. A total of 160 patients were recruited in this research and 132 patients were included in the safety analyses. Among these patients, 72 cases were classified into control group and 60 cases into study group. The mean number of lymph nodes harvested from patients in study group was 19.3 ± 6.7 (range from 4 to 38), which was higher than that in control group (15.1 ± 5.7 (range from 3 to 29)) (p < 0.001). The mean number of positive lymph nodes got from patients in study group was 1.7 ± 3.5 (range from 0 to 22), which was also higher than that in control group (0.7 ± 1.4 (range from 0 to 7)) (p = 0.045). In study group, there were 30 patients (50%) proved to be N0, and remaining 30 patients (50%) were N1 or N2. However, 50 patients (69.4%) were N0 and 22 patients (30.6%) were N1 or N2 in control group. The rate of N0 in control group was significantly higher than that in study group (p = 0.023). Injecting carbon nanoparticle suspension could get a more accurate nodal staging to receive enough chemoradiotherapy, improving prognosis. Besides, injecting carbon nanoparticles suspension at four points 5 cm, 10 cm, 15 cm and 20 cm away from the anus by "sandwich" method was a new try.Trial registration: This study was registered with ClinicalTrials.gov, number ChiCTR1900025127 on 12/8/2019.
本研究旨在评估碳纳米粒子是否能提高结直肠癌(CRC)淋巴结分期的准确性。我们在南京大学医学院附属医院普外科进行了一项随机对照试验,共纳入 160 例 CRC 患者,其中 132 例患者纳入安全性分析。在这些患者中,72 例患者被分为对照组,60 例患者被分为研究组。研究组患者的平均淋巴结检出数为 19.3±6.7(范围为 438),高于对照组的 15.1±5.7(范围为 329)(p<0.001)。研究组患者的平均阳性淋巴结数为 1.7±3.5(范围为 022),也高于对照组的 0.7±1.4(范围为 07)(p=0.045)。在研究组中,有 30 例(50%)患者被证实为 N0,其余 30 例(50%)患者为 N1 或 N2。然而,对照组中有 50 例(69.4%)患者为 N0,22 例(30.6%)患者为 N1 或 N2。对照组 N0 率明显高于研究组(p=0.023)。注射碳纳米粒子混悬液可以获得更准确的淋巴结分期,从而接受足够的放化疗,改善预后。此外,采用“三明治”法在距肛门 5cm、10cm、15cm、20cm 处的四个点注入碳纳米粒子混悬液是一种新的尝试。试验注册:本研究于 2019 年 12 月 8 日在 ClinicalTrials.gov 上注册,编号 ChiCTR1900025127。