Objective To investigate the potential value of miR-141 as a diagnostic blood biomarker expression level in patients with colorectal cancer(CRC)and its change after radical CRC resection.Methods 75 CRC patients admitted to Affiliated to Medical College of Xi'an Jiaotong University 3201 Hospital from April 2019 to March 2021 were included in the experimental group,and 20 patients who received planned surgery for inguinal hernia during the same period were used as non-cancer control group.Surgical tissue and serum samples of these patients were collected.Microarray analysis was performed for miRNAs with significant expression differences in CRC tissues and serum.Real-time quantitative PCR(qRT-PCR)was used to verify the expression level of miR-141 in serum samples of the patients before surgery and at the 3rd day after surgery,and the relationship between miR-141 and clinicopathological characteristics of CRC patients was analyzed.Results By miRNA microarray analysis,we confirmed that 12 miRNAs were up-regulated simultaneously in tissue and serum samples of CRC patients,among which miR-141 was the most significantly up-regulated.Meanwhile,the relative expression level of miR-141 in serum of CRC group was significantly higher than that of non-cancer control group after qRT-PCR verification[2.50(1.06,3.12)vs.0.97(0.68,1.21),Z=-5.842,P＜0.05].According to ROC curve analysis,the AUC value of preoperative serum miR-141 for the diagnosis of CRC was 0.927(95％CI:0.862～0.992).When serum miR-141 ≥ 1.418,the accuracy of distinguishing between CRC and non-cancer control groups was 90.53％.Combined detection of serum miR-141 could increase the diagnostic AUC value of carcinoembryonic antigen and carbohydrate antigen-199 to 0.944(95％CI:0.899-0.998).For CRC patients,the relative expression level of serum miR-141 after radical resection was significantly lower than that before surgery[1.85(1.29,2.22)vs.2.55(2.07,3.18),Z=-5.416,P＜0.001].For those who did not receive radical resection,the relative expression level of serum miR-141 after surgery was slightly lower than that before surgery[2.28(1.72,2.74)vs.2.45(2.06,2.85)],but the difference was not statistically significant(Z=-1.917,P=0.055).The expression level of Mir-141 in serum of CRC patients was correlated with UICC stage and histological grade(P＜0.05).Conclusion Serum miR-141 reflects the pathological changes of CRC patients and can be used as a biomarker for non-invasive diagnosis of CRC.

Objective:To investigate the feasibility and clinical value of endovascular treatment of iliac vein disease via the great saphenous vein approach.Methods:Eighty-six patients with nonthrombotic left iliac vein compression lesions identified by anterograde lower limb vein angiography were divided into 2 groups: group A ( n=46) was treated via great saphenous vein and group B ( n=40) was treated via femoral vein. The success rate of puncture, time consuming of puncture catheterization, postoperative bed immobilization and complication rate of puncture were observed and compared between the two groups. Results:The puncture success rate was 97.8% (45/46) in group A and 100% (40/40) in group B, there was no significant difference between the two groups（ P>0.05）. The average puncture time was (9.4±2.7) min in group A and (5.5±1.3) min in group B ( P<0.05). The complication rate of group A was lower than that in group B ( P<0.05). The patency rate of iliac vein stent was 100%, as indicated by venous color ultrasound or angiography. Conclusion:Endovascular treatment of iliac vein disease via great saphenous vein approach is a safe and feasible method with less trauma and easier postoperative care.

Objective:To perform optical surface monitoring-based three-dimensional (3D) in vivo dose verification for patients with left breast cancer undergoing deep inspiration breath-hold surface-guided radiation therapy (DIBH-SGRT) and to investigate the dosimetric differences in the target volumes and related factors affecting γ pass rates. Methods:Totally 20 patients with left breast cancer who received DIBH-SGRT at the Department of Radiation Oncology, Women′s Hospital, School of Medicine, Zhejiang University were selected. The optical surface monitoring-based intrafractional displacement deviations of the patients during DIBH were recorded. Meanwhile, electronic portal imaging device (EPID)-based in vivo dosimetry (EIVD) verification was performed for patients during the DIBH-SGRT, and γ pass rates were measured with the criteria of 2 mm/2%, 3 mm/3%, and 3 mm/5%. The dosimetric differences between planning target volumes (PTVs) and organs at risk (OARs) were analyzed based on dose-volume histograms (DVHs). Furthermore, Pearson correlation analysis was employed to determine the correlation of three γ pass rates with dosimetric differences and displacement deviations. Results:The average pass rates with the criteria of 2 mm/2%, 3 mm/3%, and 3 mm/5% were determined at 73.43%, 86.00%, and 92.96%, respectively, and the average deviations between EIVD measured doses and planned doses in PTV_TB and PTV Dmean were proved to be 0.23% and 0.59%, respectively ( P > 0.05). Pearson analysis revealed that the γ pass rates exhibited a weak correlation with dosimetric differences in PTVs( R<0.7) but strong correlations with intrafractional displacement deviations in Lat and Vert directions during DIBH ( R > 0.7). Conclusions:EIVD verification can ensure the high accuracy of dose delivery in PTVs during DIBH-SGRT for left breast cancer. Additionally, the EIVD verification system has the potential to detect displacement deviations during breath holding.

Objective:To investigate the safety, feasibility and accuracy of esophageal sponge cytology in esophageal carcinoma screening in high-incidence districts.Methods:Opportunistic screening for esophageal carcinoma was conducted on individuals aged 40-75 years with high-risk factors for esophageal carcinoma and visited out-patient clinic in Lianshui People's Hospital from May 2021 to June 2022. A new esophageal cell collector independently developed in China was used for esophageal sponge cytology sampling followed by cytopathological analysis. Atypical squamous cells or more severe lesions were defined as positive esophageal sponge cytology. Then gastroscopy was performed, and all suspicious areas under the endoscopy were biopsied for histopathological examination. Gastroscopy, biopsy histopathology and esophageal sponge cytology were conducted blindly in pairs. Outcome measures included adverse reactions during sampling, subject tolerability (using a visual simulation score), sampling quality, and diagnostic efficacy of esophageal sponge cytology using gastroscopy plus biopsy histopathology as the gold standard.Results:A total of 1 590 patients completed the screening program. During esophageal sponge cytology sampling, no serious adverse events were observed, and the adverse reactions were mainly manifested as vomiting during sampling [0.31% (5/1 590)] and sore throat after sampling [2.45% (39/1 590)], all of which resolved spontaneously without further medical intervention. The majority of subjects [98.62% (1 568/1 590)] reported good tolerance during the procedure. After sampling, 1 526 (95.97%) subjects had completely expanded sponge material, meeting the standard of good sampling quality. The scanning analysis of the digital pathology system showed that the number of sampled cells in 1 590 subjects ranged (2.01-4.00)×10 6, with a median of 3.48×10 6 cells, which could meet the requirements for interpreting cytological results. Using the positive esophageal sponge cytology for the diagnosis of esophageal carcinoma including high-grade intraepithelial neoplasia, esophageal squamous cell carcinoma and adenocarcinoma of esophagogastric junction, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 98.57% (69/70), 91.51% (1 391/1 520), 34.85% (69/198), 99.93% (1 391/1 392), and 91.82% (1 460/1 590), respectively. Conclusion:Esophageal sponge cytology presents promising diagnostic efficacy for esophageal carcinoma screening, offering a simple, safe, convenient, and effective approach in high-incidence esophageal carcinoma regions.

Purpose: This study aimed to compare and analyze the feasibility and long-term efficacy of prostatic capsule-sparing (PCS) and nerve-sparing (NS) radical cystectomy in the treatment of bladder cancer. Methods: From June 2004 to December 2021, our institution treated and followed 145 patients who underwent radical cystectomy with neobladder reconstruction for over a year. These patients were divided into 2 groups: PCS (n=74) and NS (n=71). To minimize potential biases, 1:1 propensity score matching was utilized to compare oncological outcomes, functional outcomes, and complications between the groups. Additionally, Kaplan-Meier analysis and the log-rank test were used to evaluate survival differences between the PCS and NS groups. Results: The median follow-up durations for PCS and NS were 155 and 122 months, respectively. After adjusting for propensity scores, a total of 96 patients (48 in each group) were included for further analysis. Kaplan-Meier curves showed no statistically significant differences in metastasis-free probability (P=0.206), cancer-specific survival (P=0.091), and overall survival (P=0.208). The daytime urinary control (UC) rate at 3, 6, and 12 months postoperatively was 72.9%, 91.7%, and 97.9% in the PCS group and 47.9%, 79.2%, and 91.7% in the NS group, respectively (P=0.012, P=0.083, and P=0.362). The nocturnal UC rate was 54.2%, 85.4%, and 95.8% in the PCS group, and 31.3%, 60.4%, and 83.3% in the NS group, respectively (P=0.023, P=0.006, and P=0.091). Regarding erectile function recovery, 62.5% of patients in the PCS group and 22.9% in the NS group returned to preoperative levels (P<0.001). Conclusions PCS outperformed NS in restoring UC and sexual function and did not affect oncological outcomes. However, PCS was associated with a higher risk of complications linked to bladder-neck obstruction.

Purpose: This study aimed to compare and analyze the feasibility and long-term efficacy of prostatic capsule-sparing (PCS) and nerve-sparing (NS) radical cystectomy in the treatment of bladder cancer. Methods: From June 2004 to December 2021, our institution treated and followed 145 patients who underwent radical cystectomy with neobladder reconstruction for over a year. These patients were divided into 2 groups: PCS (n=74) and NS (n=71). To minimize potential biases, 1:1 propensity score matching was utilized to compare oncological outcomes, functional outcomes, and complications between the groups. Additionally, Kaplan-Meier analysis and the log-rank test were used to evaluate survival differences between the PCS and NS groups. Results: The median follow-up durations for PCS and NS were 155 and 122 months, respectively. After adjusting for propensity scores, a total of 96 patients (48 in each group) were included for further analysis. Kaplan-Meier curves showed no statistically significant differences in metastasis-free probability (P=0.206), cancer-specific survival (P=0.091), and overall survival (P=0.208). The daytime urinary control (UC) rate at 3, 6, and 12 months postoperatively was 72.9%, 91.7%, and 97.9% in the PCS group and 47.9%, 79.2%, and 91.7% in the NS group, respectively (P=0.012, P=0.083, and P=0.362). The nocturnal UC rate was 54.2%, 85.4%, and 95.8% in the PCS group, and 31.3%, 60.4%, and 83.3% in the NS group, respectively (P=0.023, P=0.006, and P=0.091). Regarding erectile function recovery, 62.5% of patients in the PCS group and 22.9% in the NS group returned to preoperative levels (P<0.001). Conclusions PCS outperformed NS in restoring UC and sexual function and did not affect oncological outcomes. However, PCS was associated with a higher risk of complications linked to bladder-neck obstruction.

Purpose: This study aimed to compare and analyze the feasibility and long-term efficacy of prostatic capsule-sparing (PCS) and nerve-sparing (NS) radical cystectomy in the treatment of bladder cancer. Methods: From June 2004 to December 2021, our institution treated and followed 145 patients who underwent radical cystectomy with neobladder reconstruction for over a year. These patients were divided into 2 groups: PCS (n=74) and NS (n=71). To minimize potential biases, 1:1 propensity score matching was utilized to compare oncological outcomes, functional outcomes, and complications between the groups. Additionally, Kaplan-Meier analysis and the log-rank test were used to evaluate survival differences between the PCS and NS groups. Results: The median follow-up durations for PCS and NS were 155 and 122 months, respectively. After adjusting for propensity scores, a total of 96 patients (48 in each group) were included for further analysis. Kaplan-Meier curves showed no statistically significant differences in metastasis-free probability (P=0.206), cancer-specific survival (P=0.091), and overall survival (P=0.208). The daytime urinary control (UC) rate at 3, 6, and 12 months postoperatively was 72.9%, 91.7%, and 97.9% in the PCS group and 47.9%, 79.2%, and 91.7% in the NS group, respectively (P=0.012, P=0.083, and P=0.362). The nocturnal UC rate was 54.2%, 85.4%, and 95.8% in the PCS group, and 31.3%, 60.4%, and 83.3% in the NS group, respectively (P=0.023, P=0.006, and P=0.091). Regarding erectile function recovery, 62.5% of patients in the PCS group and 22.9% in the NS group returned to preoperative levels (P<0.001). Conclusions PCS outperformed NS in restoring UC and sexual function and did not affect oncological outcomes. However, PCS was associated with a higher risk of complications linked to bladder-neck obstruction.

Objective To evaluate the efficacy and safety of a domestic arterial thrombus aspiration catheter in treating acute arterial ischemic events in the experimental dogs,and to compare this catheter with Penumbra suction catheter.Methods Acute ischemic embolism model was established in the external carotid and renal arteries of experimental dogs,and the experimental dogs were randomly assigned to the study group and control group.The embolized blood vessels were treated with thrombectomy.Results A total of 12 experimental dogs were enrolled in this study,with 6 dogs in each group.All of the 12 experimental dogs were successfully modeled.In the study group and the control group,the cumulative success rates of thrombectomy were 92.9％and 66.7％respectively(P＞0.05),the incidences of intraoperative vascular dissection were 0％and 8.3％respectively(P＞0.05),and the incidences of vasospasm were 35.7％and 0.75％respectively(P＞0.05).Conclusion In treating thrombus-embolized blood vessels with mechanical thrombectomy in experimental dogs,no statistically significant differences in the efficacy and safety exist between using domestic arterial thrombus aspiration catheter and using Penumbra suction catheter.(J Intervent Radiol,2023,32:1207-1210)

Objective:To evaluate the efficacy and safety of oral anisodine hydrobromide tablets in the treatment of nonarteritic anterior ischemic optic neuropathy (NAION).Methods:A multicenter nonrandomized controlled trial was conducted.A total of 282 acute NAION patients (282 eyes) were recruited from 16 hospitals in China from July 2020 to May 2021.Patients were divided into two groups according to treatment methods, which were control group (124 cases, 124 eyes) receiving regular treatment including citicoline sodium plus Ginkgo biloba leaf liquid extract or Ginkgo biloba leaf extract tablets plus mecobalamin, and experimental group (158 cases, 158 eyes) receiving treatment in control group plus oral anisodine hydrobromide tablets 1 mg, twice daily for 2 to 3 months.Best corrected visual acuity (BCVA), visual field index (VFI), peripapillary retinal nerve fiber layer (pRNFL) and radial peripapillary capillary vessel density (RPC) were assessed at 1, 2, 3, and 6 months after enrollment using the standard decimal visual acuity chart, 750i Humphery visual field analyzer, Cirrus HD-OCT 4000/Cirrus HD-OCT 5000, RTVue-XR optical coherence tomography respectively.The primary outcomes were BCVA and VFI, and the secondary outcomes were pRNFL, RPC, and the side effects during the follow-up.The study adhered to the Declaration of Helsinki.All patients were fully informed about the treatment and purpose of this study and voluntarily signed the informed consent form.The study protocol was approved by Chinese PLA General Hospital (No.S2020-021-01). Results:In all, 242 patients (242 eyes) completed the follow-up of BCVA, and 98 patients (98 eyes) completed the VFI follow-up.In terms of visual function, BCVA and VFI improved significantly over time in the two groups, and BCVA and VFI were better in experimental group than in control group at various follow-up time points (all at P<0.05). In terms of structure, pRNFL gradually decreased in both groups with the extension of treatment, and pRNFL was significanthy thinner in experimental group than in control group at various follow-up time points (all at P<0.05). There was no significant difference in RPC between the two groups at the last follow-up ( P>0.05). There were two cases with side effects and one case was discontinued due to side effects 25 days after enrollment. Conclusions:Oral anisodine hydrobromide can improve visual acuity and visual field in NAION and accelerate the regression of optic disc edema, with good safety.

With the enormous resources having been invested in oncology drugs development in China in recent years, the Center for Drug Evaluation (CDE) of National Medical Products Administration has been issuing a number of technical guidelines to further standardize the requirements on implementation and registration of domestic oncology clinical trials. As data is the cornerstone of clinical trials, data integrity and quality will directly decide the outcome of clinical studies. Given the specific characteristics of oncology therapeutic clinical trials, and combined with the clinical data standards established by the Clinical Data Interchange Standards Consortium (CDISC) and the issued industrial guidelines, this article introduces the general considerations of clinical data management for oncology clinical trials, with the aim of emphasizing normative data collection and timely data monitoring to ensure the data quality and reliability of results of the study. This article discusses the impact of complex study design on CRF, design CRF according to CDASH, develop DVP scientifically, rolling submissions and data cut-off.