Carbon Nanoparticle Suspension Could Improve Nodal Staging for Patients with Colorectal Cancer: A Randomized Controlled Trial

2019 ◽  
Author(s):  
Wei Ge ◽  
Qiang Li ◽  
Wen-jia Liu ◽  
Xiao-Qi Zhang ◽  
Xiang-shan Fan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Nodal Staging ◽  
Nanoparticle Suspension ◽  
Carbon Nanoparticle ◽  
Randomized Controlled ◽  
Carbon Nanoparticle Suspension

scholarly journals Carbon nanoparticle suspension could help get a more accurate nodal staging for patient with rectal cancer

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Wei Ge ◽  
Qiang Li ◽  
Wen-jia Liu ◽  
Xiao-Qi Zhang ◽  
Xiang-shan Fan ◽  
...  
Keyword(s):  
Lymph Nodes ◽  
Carbon Nanoparticles ◽  
Controlled Trial ◽  
Control Group ◽  
Study Group ◽  
Nodal Staging ◽  
Nanoparticle Suspension ◽  
Carbon Nanoparticle ◽  
The Mean ◽  
Carbon Nanoparticle Suspension

AbstractThis 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.

scholarly journals Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rui Luo ◽  
Fangfang Zheng ◽  
Haobo Zhang ◽  
Weiquan Zhu ◽  
Penghui He ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Natural Orifice ◽  
Specimen Extraction ◽  
Natural Orifice Specimen Extraction ◽  
Robotic Assisted ◽  
Randomized Controlled ◽  
Robotic Assisted Surgery ◽  
Secondary Outcomes

Abstract Background Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes. Method/design Accordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system. Discussion This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes. Trial registration ClinicalTrials.govNCT04230772. Registered on January 15, 2020.

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