Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8％)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P＜0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P＞0.05).②The visualization rate in the ICG group was 64.71％(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P＞0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P＜0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P＜0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.

Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8％)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P＜0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P＞0.05).②The visualization rate in the ICG group was 64.71％(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P＞0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P＜0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P＜0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.

Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8％)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P＜0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P＞0.05).②The visualization rate in the ICG group was 64.71％(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P＞0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P＜0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P＜0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.

Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8％)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P＜0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P＞0.05).②The visualization rate in the ICG group was 64.71％(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P＞0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P＜0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P＜0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.

Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8％)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P＜0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P＞0.05).②The visualization rate in the ICG group was 64.71％(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P＞0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P＜0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P＜0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.

Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8％)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P＜0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P＞0.05).②The visualization rate in the ICG group was 64.71％(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P＞0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P＜0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P＜0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.

Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8％)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P＜0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P＞0.05).②The visualization rate in the ICG group was 64.71％(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P＞0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P＜0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P＜0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.

Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8％)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P＜0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P＞0.05).②The visualization rate in the ICG group was 64.71％(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P＞0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P＜0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P＜0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.

Objective:This article analyzed the current situation, similarities and differences and main problems of the registration and management systems of innovative medical devices in China and the United States.Methods:This article summarized the requirements and policies for the registration management of innovative medical devices in China and the United States, as well as the development and differences of the registration of innovative medical devices in China and the United States, and the main problems in the registration management of innovative medical devices in China.Results:At present, the development level of medical device industry in China and the United States was different, facing different development problems, and there were differences in the access standards and management methods of innovative medical devices. The registration management system established for innovative medical devices in China was gradually improving, and to a certain extent, it had promoted the enthusiasm of innovative product research and development and registration applications, but there were also problems such as unclear innovation evaluation scales, insufficient early intervention of review resources, and insufficient utilization of post-marketing data.Conclusions:Drawing on the beneficial experience of breakthrough device registration management in the United States, we will improve the registration management system for innovative products and shorten the review and approval cycle by clarifying the identification criteria for innovative medical devices, promoting the placement of review resources in the R&D stage, and further strengthening the use of post-marketing data and regulatory scientific research.

Purpose: This study aims to evaluate the efficacy and safety of a new combination treatment of vinorelbine and pyrotinib in human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) and provide higher level evidence for clinical practice. Materials and Methods: This was a prospective, single-arm, phase 2 trial conducted at three institutions in China. Patients with HER2-positive MBC, who had previously been treated with trastuzumab plus a taxane or trastuzumab plus pertuzumab combined with a chemotherapeutic agent, were enrolled between March 2020 and December 2021. All patients received pyrotinib 400 mg orally once daily plus vinorelbine 25 mg/m2 intravenously or 60-80 mg/m2 orally on day 1 and day 8 of 21-day cycle. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included the objective response rate (ORR), disease control rate (DCR), overall survival, and safety. Results: A total of 39 patients were enrolled. All patients had been pretreated with trastuzumab and 23.1% (n=9) of them had accepted trastuzumab plus pertuzumab. The median follow-up time was 16.3 months (95% confidence interval [CI], 5.3 to 27.2), and the median PFS was 6.4 months (95% CI, 4.0 to 8.8). The ORR was 43.6% (95% CI, 27.8% to 60.4%) and the DCR was 84.6% (95% CI, 69.5% to 94.1%). The median PFS of patients with versus without prior pertuzumab treatment was 4.6 and 8.3 months (p=0.017). The most common grade 3/4 adverse events were diarrhea (28.2%), neutrophil count decreased (15.4%), white blood cell count decreased (7.7%), vomiting (5.1%), and anemia (2.6%). Conclusion Pyrotinib plus vinorelbine showed promising efficacy and tolerable toxicity as second-line treatment in patients with HER2-positive MBC.