1.Analysis of Impurities in Peptide Drug Bivalirudin Based on Three Kinds of Separation Principle Technology
Jing YIN ; Wanting WANG ; Yihong LU ; Shuqiang ZHAO ; Haiwei SHI ; Bin DI ; Minhua XUE ; Ling CAO
Chinese Journal of Modern Applied Pharmacy 2024;41(5):626-635
OBJECTIVE
To establish HPLC methods with different separation principles to analyze the relevant impurities in the APIs of bivalirudin from seven enterprises, to provide a basis for the comprehensive control of related substances of bivalirudin.
METHODS
Reversed-phase high performance liquid chromatography(RP-HPLC) was used to separate and analyze 11 kinds of impurities. Hydrophilic chromatography(HILIC)-HPLC was used to control four process impurities. Polymers were determined by size exclusion chromatography(SEC)-HPLC.
RESULTS
The established RP-HPLC could effectively separate the principal component and 11 impurities, the correction factors of 11 impurities were between 0.8−1.2, the detection concentration of bivalirudin was 0.1 μg·mL−1, and the detection limit was 0.004%. The established HILIC-HPLC could effectively separate the principal components and four process impurities, and the detection concentration of bivalirudin was 0.3 μg·mL−1, and the detection limit was 0.01%. Under SEC-HPLC conditions, the polymer and bivalirudin peaked sequentially, the resolution of the two was 2.9, the detection concentration of bivalirudin was 6 ng·mL−1, and the detection limit was 0.000 6%. Fifteen kinds of known impurities and polymers in 15 batches of samples from 7 enterprises were calculated by the self-control method of principal components, and the impurity contents from different enterprises had a certain correlation with their production processes.
CONCLUSION
The three different principles of the method have good specificity, high sensitivity, good durability, and reliable results, and can be used for quality control of substances related to bivalirudin.
2.A Cohort study of synchronized immersion course to improve teaching effectiveness of clinical practice of surgery for eight-year program students
Zhenghao CAI ; Minhua ZHENG ; Qian GU ; Lin HE ; Zhenye GONG ; Weiguo HU ; Yonggang HE ; Lu ZANG
Journal of Surgery Concepts & Practice 2024;29(3):254-259
Objective To investigate the application of synchronized immersion course(SIC)in teaching of clinical practice of surgery for eight-year program students.Methods A total of 94 eight-year program students in French class and 4+4 class who received SIC in the study of surgery in Ruijin Clinical School,Shanghai Jiao Tong University from September 2017 to June 2019 were selected as the pilot group.A total of 91 students in English class who were taught in the traditional way in the same period were selected as a horizontal control group.A total of 84 students in French class and 4+4 class who were studying from September 2015 to June 2017 were selected as the longitudinal control group.Teaching satisfaction evaluation,examination results and specialization choice were compared among students in each group to assess teaching effectiveness.Results The total score(3.8±0.3)and satisfaction rate(98.9%)of the questionnaire in the pilot group were better than those in the horizontal control group(3.6±0.4,90.1%)(P=0.001,P=0.008).For the case analysis station in objective structured clinical examination(OSCE),the mean score(86.2±6.9)and pass rate(97.9%)in the pilot group were better than those in the horizontal control group(79.7±11.4,89.0%)(P=0.001,P=0.014),as well as better than those in the longitudinal control group(79.5±13.5,88.1%)(P=0.001,P=0.009).For the history inquiry station,the mean score(86.3±10.7)and pass rate(96.8%)in the pilot group were better than those in the horizontal control group(81.4±11.6,86.8%)(P=0.003,P=0.013).The proportion of students choosing the surgical specialty was higher in the pilot group(55.3%)than in the horizontal control group(46.2%)and the longitudinal control group(44.0%)without statistically significant difference.Conclusions SIC can help eight-year program students strengthen their clinical thinking and practice skills.Meanwhile,SIC can increase students'satisfaction with teaching and their interest in surgery.
3.Clinicopathological analysis of 6 cases of diffuse paediatric-type high-grade glioma,H3-wildtype and IDH-wildtype
Ruifen WANG ; Wenbin GUAN ; Minhua YAN ; Lu JU ; Huiru HAN ; Lifeng WANG
Chinese Journal of Clinical and Experimental Pathology 2024;40(5):484-489
Purpose To investigate the clinicopathological features and molecular features of diffuse paediatric-type high-grade glioma,H3-wildtype and IDH-wildtype(pHGG H3/IDH WT)of central nervous system.Methods The clinical and pathological data of 6 cases of pHGG H3/IDH WT diagnosed by Department of Pathology,Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine were retrospectively ana-lyzed.The expression of GFAP,Olig2,Syn,NeuN,IDH1,H3K27M was detected by immunohistochemistry(automatic im-munohistochemical staining device).The EGFR and MYCN gene amplification was detected by FISH.IDH,H3F3A and TERT gene mutations were detected by Sanger sequencing.The literatures were reviewed.Results The 6 patient's age ranged from 5 to 11 years,with a median age of 7.5 years.Among them,there were 2 males and 4 females,with a male to female ratio of 1∶2.The clinical symptoms were limb weakness,hemi-plegia,vomiting,convulsions,blurred vision and so on.Tumors were located in supratentorial brain for 5 cases and one in brain stem and cerebellum.Histologically,3 cases showed the mor-phological features of high-grade glioma,2 of which with giant cells.Two cases showed embryonal tumor-like features,and one had both high-grade glioma and embryonal tumor-like morpho-logical features.Microvascular proliferation and/or necrosis were present in 5 cases.Myxoid/microcystic stroma was found in 1 case.By immunohistochemistrically,the tumor cells were par-tially or focally positive for GFAP(6/6)and Olig2(6/6),fo-cally positive for Syn(3/6)and NeuN(1/6),and negative for IDH1,H3K27M,H3G34V and H3G34R.ATRX,H3K27me3,INI1 and BRG1 were diffusely positive(6/6).The positive rate of p53 was 5%-95%,and Ki67 proliferation index was 40%-90%.Molecular analysis showed that all 6 cases were IDH1/2 and H3F3A wild-type.MYCN amplification was observed in 2 cases.Two cases of EGFR amplification with polyploidy;one case had both EGFR amplification and MYCN amplification.PDGFRA amplification was observed in one case.For treatment and follow-up,the patients received postoperative radiotherapy and/or temozolomide chemotherapy;three patients died at 1 to 5 months after operation.Two patients survived and were followed up for 4 and 7 months,respectively.One patient was lost to fol-low-up.Conclusions pHGG H3/IDH WT is a highly malignant tumor with glioblastoma-like or embryonal tumor-like features.According to the molecular characteristics,it can be divided into three molecular subtypes,RTK1,RTK2 and MYCN.pHGG MYCN has the worst prognosis.Attention should be paid to the differential diagnosis of other pediatric or adult high-grade glio-mas and embryonal tumors.
4.Clinicopathological analysis of 2 cases of infant-type hemispheric glioma with ALK gene fusion
Ruifen WANG ; Wenbin GUAN ; Minhua YAN ; Huiru HAN ; Lu JU ; Lifeng WANG
Chinese Journal of Clinical and Experimental Pathology 2024;40(7):700-704
Purpose To investigate the clinicopathological features,molecular features,treatment and prognosis of infant-type hemispheric glioma(IHG)with ALK gene fusion of central nervous system.Methods Clinical data of 2 cases of IHG were collected,and the expression of GFAP,Olig2,Syn,NeuN,H3K27M,H3K27me3,H3G34V,H3G34R,ALK,and BRAF were detected using immunohistochemistry.FISH and NGS method was used to detect ALK fusion genes,and relevant liter-atures were reviewed.Results Case 1,a male,15 months old,showed a huge mass in the left frontal and temporal lobe on cranial MRI.Case 2(external hospital consultation),a male,18 months old,was found to have a space occupying lesion in the frontaltemporal lobe.Microscopic examination:in case 1,tumor cells showed diffuse patchy pattern,with small nodular shapes in some areas which separated by fibrous blood vessels.The cell density was high,and the nucleus was round or oval.The mitotic was easy to see,accompanied by bleeding and nec-rosis.In case 2,tumor cells were diffusely distributed,some of them formed pseudorosette around blood vessels and others ar-ranged in bundles.The cells were mild to moderate dysplasia with round or oval nuclei,light staining,small nucleoli,rare mitotic figures,and no microvascular proliferation or necrosis.Immunophenotypes:in case 1 tumor cells were focal positive for GFAP and NeuN,diffuse positive for H3K27me3,ALK(cyto-plasm and cell membrane),and ATRX,p53 positive(30%),negative for Olig2,Syn,H3K27M,H3G34V,H3G34R,and BRAF,Ki67 proliferation index of 20%.In case 2:tumor cells were diffusedly expressed GFAP,ATRX,H3K27me3,ALK(cytoplasm and cell membrane),and Olig2,Syn was weakly positive,NeuN and p53 were negative,and Ki67 proliferation index was 5%.FISH and NGS tests showed ALK gene fusion in both cases,with EML4::ALK fusion in case 1 and LRRFIP1::ALK fusion in case 2.Follow up for 7 months showed that the residual lesion in case 1 had shrunk and was generally in good condition;case 2 lost follow-up.Conclusion The histology of IHG often presents as high-grade gliomas or accompanied by an-aplastic features.The heterogeneity of ALK variants can also manifest as low-grade gliomas,which need to be differentiated from other high-grade gliomas,desmoplastic infantile gangliogli-oma/astrocytoma,ependymoma,etc.
5.Clinical value of magnetic resonance imaging based integrated deep learning model for predic-ting the times of linear staplers used in middle-low rectal cancer resection
Zhanwei FU ; Zhenghao CAI ; Shuchun LI ; Luyang ZHANG ; Lu ZANG ; Feng DONG ; Minhua ZHENG ; Junjun MA
Chinese Journal of Digestive Surgery 2023;22(9):1129-1138
Objective:To investigate the clinical value of magnetic resonance imaging (MRI) based integrated deep learning model for predicting the times of linear staplers used in double stapling technique for middle-low rectal cancer resection.Methods:The retrospective cohort study was conducted. The clinicopathological data of 263 patients who underwent low anterior resection (LAR) for middle-low rectal cancer in Ruijin Hospital of Shanghai Jiaotong University School of Medicine from January 2018 to December 2022 were collected as training dataset. There were 183 males and 80 females, aged 63(55,68)years. The clinicopathological data of 128 patients with middle-low rectal cancer were collected as validation dataset, including 83 males and 45 females, with age as 65(57,70)years. The training dataset was used to construct the prediction model, and the validation dataset was used to validate the prediction model. Observation indicators: (1) clinicopathological features of patients in the training dataset; (2) influencing factors for ≥3 times using of linear staplers in the operation; (3) prediction model construction; (4) efficiency evaluation of prediction model; (5) validation of prediction model. Measurement data with skewed distribution were represented as M( Q1, Q3), and Mann-Whitney U test was used for comparison between groups. Count data were expressed as absolute numbers, and comparison between groups was conducted using the chi-square test. Wilcoxon rank sum test was used for non-parametric data analysis. Univariate analysis was conducted using the Logistic regression model, and multivariate analysis was conducted using the Logistic stepwise regression model. The receiver operating characteristic (ROC) curve was draw and the area under the curve (AUC) was calculated. The AUC of the ROC curve >0.75 indicated the prediction model as acceptable. Comparison of AUC was conducted using the Delong test. Results:(1) Clinicopathological features of patients in the training dataset. Of the 263 patients, there were 48 cases with linear staplers used in the operation ≥3 times and 215 cases with linear staplers used in the operation ≤2 times. Cases with preoperative serum carcinoembryonic antigen (CEA) >5 μg/L, cases with anastomotic leakage, cases with tumor diameter ≥5 cm were 20, 12, 13 in the 48 cases with linear staplers used ≥3 times in the operation, versus 56, 26, 21 in the 215 cases with linear staplers used ≤2 times in the operation, showing significant differences in the above indicators between them ( χ2=4.66, 5.29, 10.45, P<0.05). (2) Influencing factors for ≥3 times using of linear staplers in the operation. Results of multivariate analysis showed that preoperative serum CEA >5 μg/L and tumor diameter ≥5 cm were independent risk factors for ≥3 times using of linear staplers in the operation ( odds ratio=2.26, 3.39, 95% confidence interval as 1.15-4.43, 1.50-7.65, P<0.05). (3) Prediction model construction. According to the results of multivariate analysis, the clinical prediction model was established as Logit(P)=-2.018+0.814×preoperative serum CEA (>5 μg/L as 1, ≤5 μg/L as 0)+ 1.222×tumor diameter (≥5 cm as 1, <5 cm as 0). The image data segmented by the Mask region convolutional neural network (MASK R-CNN) was input into the three-dimensional convolutional neural network (C3D), and the image prediction model was constructed by training. The image data segmented by the MASK R-CNN and the clinical independent risk factors were input into the C3D, and the integrated prediction model was constructed by training. (4) Efficiency evaluation of prediction model. The sensitivity, specificity and accuracy of the clinical prediction model was 70.0%, 81.0% and 79.4%, respectively, with the Yoden index as 0.51. The sensitivity, specificity and accuracy of the image prediction model was 50.0%, 98.3% and 91.2%, respectively, with the Yoden index as 0.48. The sensitivity, specificity and accuracy of the integrated prediction model was 70.0%, 98.3% and 94.1%, respectively, with the Yoden index as 0.68. The AUC of clinical prediction model, image prediction model and integrated prediction model was 0.72(95% confidence interval as 0.61-0.83), 0.81(95% confidence interval as 0.71-0.91) and 0.88(95% confidence interval as 0.81-0.95), respectively. There were significant differences in the efficacy between the integrated prediction model and the image prediction model or the clinical prediction model ( Z=2.98, 2.48, P<0.05). (5) Validation of prediction model. The three prediction models were externally validated by validation dataset. The sensitivity, specificity and accuracy of the clinical prediction model was 62.5%, 66.1% and 65.6%, respectively, with the Yoden index as 0.29. The sensitivity, specificity and accuracy of the image prediction model was 58.8%, 95.5% and 92.1%, respectively, with the Yoden index as 0.64. The sensitivity, specificity and accuracy of the integrated prediction model was 68.8%, 97.3% and 93.8%, respectively, with the Yoden index as 0.66. The AUC of clinical prediction model, image prediction model and integrated prediction model was 0.65(95% confidence interval as 0.55-0.75), 0.75(95% confidence interval as 0.66-0.84) and 0.84(95% confidence interval as 0.74-0.93), respec-tively. There was significant differences in the efficacy between the clinical prediction model and the integrated prediction model ( Z=3.24, P<0.05). Conclusion:The MRI-based deep-learning model can help predicting the high-risk population with ≥3 times using of linear staplers in resection of middle-low rectal cancer with double stapling technique.
6.Technical practice and development direction of minimally invasive gastric surgery in digital medicine era
Shuchun LI ; Lu ZANG ; Minhua ZHENG
Chinese Journal of Digestive Surgery 2022;21(5):598-602
After nearly 30 years of high-speed development of minimally invasive gastric surgery in China, the surgical techniques are well developed. The concept of gastric cancer treatment is constantly changing as the deepening understanding of gastric cancer. Minimally invasiveness and precision is an inevitable trend in gastric surgery. At the same time, science and technology are fast-evolving, which greatly improved the performance of both soft- and hardware. In the future, surgical technology, real-time data and artificial intelligence will be further integrated to facilitate the evolution of minimally invasive surgery to digital surgery era. Therefore, in this article, the authors elaborate on the technical practice and future directions of minimally invasive surgery in this digital medicine era from technology and scientific progress.
7.Application of minimally invasive intelligent diagnosis and treatment technology in gastric cancer
Shuchun LI ; Lu ZANG ; Minhua ZHENG
Chinese Journal of Digestive Surgery 2021;20(5):492-496
Gastric cancer is one of the most common malignant tumors in China, with a high incidence and poor prognosis. It is still the focus of current work to improve the diagnosis rate and investigate the new treatment for gastric cancer. In recent years, intelligent medicine represented by artificial intelligence has been gradually applied in gastric cancer diagnosis and treatment, especially in gastroscopy examination, imaging examination, pathological diagnosis and so on. In terms of minimally invasive surgery for gastric cancer, the emergence of new technologies such as 4K and 3D have further improved the accuracy of surgery. At the same time, laparoscopic fluorescence imaging technology represented by indocyanine green imaging is gradually becoming a new direction for the development of minimally invasive surgery. Combined with the literature at home and abroad, the authors expound the application of minimally invasive intelligent technology in the process of diagnosis and treatment of gastric cancer to fully understand the opportunities and challenges faced by gastric cancer intelligent diagnosis and treatment, break the boundaries of disciplines, and carry out a wide range of 'medical-engineering integration′ research. This will finally benefit patients with gastric cancer.
8.Clinical efficacy of gastrojejunal bypass surgery combined with radical gastrectomy following conversion therapy for gastric cancer with outlet obstruction
Tianyu JIANG ; Junjun MA ; Lu ZANG ; Xizhou HONG ; Zirui HE ; Luyang ZHANG ; Minhua ZHENG
Chinese Journal of Digestive Surgery 2021;20(9):967-973
Objective:To investigate the clinical efficacy of gastrojejunal bypass surgery combined with radical gastrectomy following conversion therapy for gastric cancer with outlet obstruction.Methods:The retrospective and descriptive study was conducted. The clinicopatho-logical data of 10 initially unresectable gastric cancer patients with outlet obstruction who were admitted to Ruijin Hospital of Shanghai Jiao Tong University School of Medicine from October 2019 to July 2020 were collected. There were 8 males and 2 females, aged from 41 to 59 years, with a median age of 53 years. Patients underwent 'sandwich therapy' of gastrojejunal bypass surgery combined with gastrectomy following conversion therapy. Observation indicators: (1) gastrojejunal bypass surgery and postoperative situations; (2) conversion therapy and complications; (3) radical gastrectomy and postoperative situations; (4) follow-up. Follow-up using outpatient examinations or telephone interview was conducted to detect postoperative complications, progress-free survival, tumor recurrence and metastasis up to March 2019. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M(range). Count data were described as absolute numbers. Results:(1) Gastrojejunal bypass surgery and postoperative situations: 10 patients received modified gastrojejunal bypass surgery combined with No.4sb lymph node dissection, without intraoperative serious complications, conversion to laparotomy or death. The operation time, volume of intraoperative blood loss, time to postoperative first flatus, time to liquid diet intake were 73 minutes(range, 60-87 minutes), 33 mL(range,20-110 mL), 3 days(range, 2-6 days), 4 days(range, 4-9 days). One patient had post-operative Clavien-Dindo grade Ⅱ complication of anastomotic bleeding, and was improved after transfusion of blood products. (2) Conversion therapy and complications: of 10 patients, 9 cases received 4 cycles of FLOT regimen. One of the 9 cases was suspended chemotherapy due to Clavien-Dindo grade Ⅱ anastomotic edema after 2 cycles of FLOT regimen. Of 10 patients, there were 6 cases with partial response and 4 cases with stable disease. Of 6 patients with partial response, 4 cases with preoperative cT4b stage were down stage to T4a stage, showing the relationship of tumor with transverse mesentery and pancreatic capsule clearer than the first exploration, 2 cases with preoperative lymph nodes fusion had shrank obviously. Of 4 patients with stable disease, 3 cases were negative for lymph nodes shranking, and the rest 1 case with tumor peritoneal metastasis diagnosed by initial laparoscopy can not be evaluated by imaging examination after chemotherapy. Two of 10 patients had Clavien-Dindo grade I complication of elevated blood glucose during the chemotherapy, which were improved after insulin therapy. (3) Radical gastrectomy and post-operative situations: 10 patients underwent radical resection after conversion therapy. Of 4 cases with stable disease, 3 cases with preoperative lymph nodes fusion showed obvious space between lymph nodes and surrounding tissues at resurgical exploration and received radical resection, 1 case with peritoneal metastasis showed abdominal wall nodelus and omental tuberosity as fibrous scars at resurgical exploration and received radical resection. The operation time, volume of intra-operative blood loss, time to postoperative first flatus, time to initial liquid diet intake, duration of total hospital stay, duration of postoperative hospital stay of 10 patients were 148 minutes(range, 95-195 minutes), 108 mL(range, 100-180 mL), 3 days(range, 2-7 days), 4 days(range, 3-9 days), 11 days(range, 10-21 days), 8 days(range, 7-16 days). Two of 10 patients had perioperative complications. Results of pathological examination of 10 patients showed the number of dissected lymph nodes as 25±6. There were 1 case of stage T1, 5 cases of stage T3, 4 cases of stage T4a. There were 1 case of stage N0, 2 cases of stage N1, 3 cases of stage N2, 4 cases of stage N3. There were 3 cases of tumor regression grade 1a, 1 case of grade 1b, 4 cases of grade 2, 2 cases of grade 3. (4) Follow-up: 10 patients were followed up for 3.9-13.0 months, with a median follow-up time of 6.0 months. The median progression-free survival time of 10 patients was 6.0 months. During the follow-up, 1 case underwent postoperative Clavien-Dindo grade Ⅱ complication of delayed gastric emptying and was improved after symptomatic treatment.Conclusion:The gastrojejunal bypass surgery combined with gastrectomy following conversion therapy for gastric cancer with outlet obstruction is safe and effective.
9.Application value of 3D laparoscope in transanal total mesorectal excision
Junjun MA ; Lu ZANG ; Bo FENG ; Aikemu BATUR ; Xizhou HONG ; Zhenghao CAI ; Luyang ZHANG ; Aiguo LU ; Yaping ZONG ; Minhua ZHENG
Chinese Journal of Digestive Surgery 2020;19(5):531-536
Objective:To investigate the application value of three-dimensional (3D) laparoscope in the transanal total mesorectal excision (TaTME).Methods:The retrospective cohort study was conducted. The clinicopathological data of 20 patients with middle and low rectal cancer who underwent TaTME in the Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine from June 2018 to October 2019 were collected. There were 15 males and 5 females, aged from 28 to 81 years, with a median age of 64 years. Of the 20 patients, 10 patients using 3D laparoscopic system for transanal approach of TaTME were divided into 3D group, and 10 patients using two-dimensional (2D) laparoscopic system for transanal approach of TaTME were divided into 2D group. Observation indicators: (1) intraoperative situations and postoperative recovery; (2) postoperative pathological examination; (3) follow-up. Follow-up was conducted by outpatient examination and telephone interview to detect survival of patients and recurrence and metastasis of tumors in patients up to April 2020. Measurement data with skewed distribution were represented as M (range), and comparison between groups was analyzed using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was analyzed using the Fisher exact propability. Comparison of ordinal data was analyzed using the Mann-Whitney U test. Results:(1) Intraoperative situations and postoperative recovery: patients in the two groups completed surgeries successfully, without tranversion to laparostomy from laparoscopic surgery, transversion to transabdominal surgery from transanal surgery, or intraoperative death. The cases with terminal ileostomy, cases with manual anstomosis or mechanical anastomosis (anastomotic methods), operation time, volume of intra-operative blood loss, duration of postoperative hospital stay, cases with anastomotic leakage or anastomotic hemorrahge (postoperative short-term complications), cases with anastomotic stenosis of the 3D group were 7, 4, 6, 150 minutes (range, 100-220 minutes), 50 mL (range, 30-100 mL), 8.5 days (range, 7.0-16.0 days), 2, 0, 1, respectively, versus 8, 5, 5, 180 minutes (range, 120-250 minutes), 100 mL (range, 30-200 mL), 9.5 days (range, 6.0-17.0 days), 1, 1, 1 of the 2D group. There was no significant difference in the terminal ileostomy, anastomotic methods, postoperative short-term complications, or anastomotic stenosis between the two groups ( P>0.05). There was no significant difference in the operation time, volume of intraoperative blood loss, or duration of postoperative hospital stay between the two groups ( Z=1.909, 1.827, 0.687, P>0.05). Patients with short-term complications in the two groups were improved after conservative treatments. There was 1 patient with anastomotic stenosis in either group, and they were improved after endoscopic balloon dilatation. (2) Postoperative pathological examination: the maximum tumor diameter, distal margin of the tumor, the number of lymph nodes harvested, cases with cancer nodes in the mesentery, cases with complete mesentery or median complete mesentery (the integrity of mesentery), cases in stage Ⅰ, Ⅱ, Ⅲ (postoperative pathological stage) of the 3D group were 3.8 cm (range, 1.8-5.0 cm), 1.0 cm (range, 0.5-2.5 cm), 14.5 (range, 6.0-19.0), 1, 9, 1, 4, 2, 4, respectively, versus 4.8 cm (range, 1.0-8.5 cm), 0.8 cm (range, 0.3-1.5 cm), 15.5 (range, 8.0-18.0), 1, 8, 2, 2, 4, 4 of the 2D group. There was no significant difference in the maximum tumor diameter, distal margin of the tumor, the number of lymph nodes harvested, the integrity of mesentery, or postoperative pathological stage between the two groups ( Z=1.673, 1.772, 0.038, 0.610, 0.482, P>0.05). There was no significant difference in the cases with cancer nodes in the mesentery between the two groups ( P>0.05). Patients in the two groups had negative distal margin and circumferential margin. (3) Follow-up: patients in the 3D group and 2D group were followed up for 11 months (range, 6-16 months) and 13 months (range, 6-21 months), respectively. During the follow-up, there was no local recurrence, distal metastasis, or tumor-related death. Conclusions:3D laparoscope applied in the TaTME can achieve similar clinical efficacy with 2D laparoscope, which may have a positive impact on the operation time and volume of intraoperative blood loss.
10.A primary investigation on application value of glasses-free three-dimensional laparoscopy system in laparoscopic radical resection of gastrointestinal malignant tumors
Zhenghao CAI ; Junjun MA ; Lu ZANG ; Feng DONG ; Bo FENG ; Jing SUN ; Yaping ZONG ; Luyang ZHANG ; Xizhou HONG ; Aiguo LU ; Minhua ZHENG
Chinese Journal of Digestive Surgery 2020;19(6):644-652
Objective:To primarily investigate the application value of glasses-free three-dimensional (3D) laparoscopy system in laparoscopic radical resection of gastrointestinal malignant tumors.Methods:The retrospective cohort study was conducted. The clinical data of 165 patients with gastrointestinal malignant tumors who were admitted to the Ruijin Hospital of Shanghai Jiaotong University School of Medicine between October 2018 and May 2019 were collected. There were 99 males and 66 females, aged from 28 to 86 years, with a median age of 63 years. There were 68 of 165 patients with gastric cancer and 97 with colorectal cancer. Sixteen patients with gastric cancer who underwent laparoscopic radical gastrectomy using the glasses-free 3D laparoscopy system were divided into glasses-free 3D gastric cancer group, and 52 patients with gastric cancer who underwent laparoscopic radical gastrectomy using the polarized glasses 3D laparoscopy system were divided into polarized glasses 3D gastric cancer group. Nineteen patients with colorectal cancer who underwent laparoscopic radical colectomy or proctectomy using the glasses-free 3D laparoscopy system were divided into glasses-free 3D colorectal cancer group, and 78 patients with colorectal cancer who underwent laparoscopic radical colectomy or proctectomy using the polarized glasses 3D laparoscopy system were divided into polarized glasses 3D colorectal cancer group. Observation indicators: (1) operative situations of patients with gastric cancer; (2) postoperative recovery of patients with gastric cancer; (3) postoperative pathological examination results of patients with gastric cancer; (4) operative situations of patients with colorectal cancer; (5) postoperative recovery of patients with colorectal cancer; (6) postoperative pathological examination results of patients with colorectal cancer; (7) follow-up. Follow-up was conducted by outpatient examination or telephone interview to detect complications and survival of patients up to the postoperative 30th day. Measurement data with skewed distribution were represented as M ( P25, P75) or M (range), and comparison between groups was analyzed by the Mann-Whitney U test. Count data were represented as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test or Fisher exact probability. Results:(1) Operative situations of patients with gastric cancer: all the 68 gastric cancer patients received successfully laparoscopic radical gastrectomy, without intraoperative complication or conversion to laparotomy. Cases with distal gastrectomy or total gastrectomy(surgical methods) , operation time, volume of intraoperative blood loss were 11, 5, 195 minutes(169 minutes, 214 minutes), 20 mL (10 mL, 90 mL) in patients of the glasses-free 3D gastric cancer group, and 31, 21, 196 minutes(173 minutes, 222 minutes), 40 mL(20 mL, 100 mL) in patients of the polarized glasses 3D gastric cancer group, with no significant difference between the two groups ( χ2=0.432, Z=-0.362, -1.065, P>0.05). (2) Postoperative recovery of patients with gastric cancer: the time to first flatus, time to initial semi-fluid diet intake, duration of postoperative hospital stay were 2 days(2 days, 3 days), 6 days(5 days, 7 days), 10 days(9 days, 14 days) in patients of the glasses-free 3D gastric cancer group, and 2 days(2 days, 3 days), 6 days(5 days, 6 days), 11 days(9 days, 14 days) in patients of the polarized glasses 3D gastric cancer group, with no significant difference between the two groups ( Z=-0.163, -1.870, -0.570, P>0.05). The postoperative complication incidence of the glasses-free 3D gastric cancer group was 12.5%(2/16), including 1 case with duodenal stump fistula, 1 case with anastomotic bleeding. The postoperative complication incidence of the polarized glasses 3D gastric cancer group was 17.3%(9/52), including 2 cases with duodenal stump fistula, 2 cases with delayed gastric emptying, 1 case with pulmonary infection, 1 case with abdominal bleeding, 1 case with anastomotic leakage, 1 case with chylous fistula, 1 case with intestinal obstruction. All the patients with complications were cured after symptomatic supportive treatment. There was no significant difference in the complication incidence between the two groups ( χ2=0.209, P>0.05). (3) Postoperative pathological examination results of patients with gastric cancer: the tumor diameter, cases in stage T1, T2, T3, T4 (tumor T staging), cases with vascular invasion, cases with nerve invasion, cases with tumor nodule, cases in stage N0, N1, N2, N3 (tumor N staging), the number of positive lymph node, the number of lymph node dissected, cases with qualified lymph node dissected, cases in stage Ⅰ, Ⅱ, Ⅲ, Ⅳ (TNM clinical staging) were 3.0 cm(2.0 cm, 5.0 cm), 5, 3, 1, 7, 8, 5, 2, 3, 2, 4, 7, 6(1, 15), 28(22, 43), 15, 4, 3, 9, 0 in patients of the glasses-free 3D gastric cancer group, and 3.5 cm(2.0 cm, 6.0 cm), 13, 10, 4, 25, 19, 23, 2, 26, 6, 7, 13, 1(0, 7), 29(21, 39), 43, 21, 10, 20, 1 in patients of the polarized glasses 3D gastric cancer group. There was no significant difference in the tumor diameter, tumor T staging, cases with vascular invasion, cases with nerve invasion, cases with tumor nodule, the number of lymph node dissected, cases with qualified lymph node dissected, TNM clinical staging between the two groups ( Z=-0.570, -0.434, χ2 =0.926, 0.851, 1.655, Z=-0.579, χ2=1.193, Z=-1.134, P>0.05). There were significant differences in the tumor N staging and the number of positive lymph node between the two groups ( Z=-2.167, -2.283, P<0.05). (4) Operative situations of patients with colorectal cancer: all the 97 colorectal cancer patients received successfully laparoscopic radical colectomy or proctectomy, without intraoperative complications or conversion to laparotomy. Cases with radical colectomy or proctectomy (surgical methods), operation time, volume of intraoperative blood loss were 7, 12, 132 minutes(97 minutes, 156 minutes), 20 mL(10 mL, 50 mL) in patients of the glasses-free 3D colorectal cancer group, and 40, 38, 124 minutes(110 minutes, 159 minutes), 25 mL(15 mL, 65 mL) in patients of the polarized glasses 3D colorectal cancer group, with no significant difference between the two groups ( χ2 =1.276, Z=-0.141, -0.863, P>0.05). (5) Postoperative recovery of patients with colorectal cancer: the time to first flatus, time to initial semi-fluid diet intake, duration of postoperative hospital stay were 2 days(1 days, 3 days), 5 days(5 days, 6 days), 8 days(7 days, 10 days) in patients of the glasses-free 3D colorectal cancer group, and 2 days(1 days, 3 days), 5 days(4 days, 6 days), 8 days(6 days, 10 days) in patients of the polarized glasses 3D colorectal cancer group, with no significant difference between the two groups ( Z=-0.678, -1.751, -1.674, P>0.05). The complication incidence of the glasses-free 3D colorectal cancer group was 15.8%(3/19), including 1 case with anastomotic leakage after low anterior proctectomy, 1 case with incision infection, 1 case with urinary tract infection. The complication incidence of the polarized glasses 3D colorectal cancer group was 14.1%(11/78), including 3 cases with anastomotic leakage after low anterior proctectomy, 2 cases with intestinal obstruction, 2 cases with urinary tract infection, 2 cases with incision infection, 1 case with anastomotic bleeding, 1 case with pulmonary infection. One of the 3 cases with anastomotic leakage after low anterior proctectomy in the polarized glasses 3D colorectal cancer group was cured after remedial terminal ileostomy. The other patients with complications were cured after symptomatic supportive treatment. There was no significant difference in the complication incidence between the two groups ( χ2=0.035, P>0.05). (6) Postoperative pathological examination results of patients with colorectal cancer: the tumor diameter, cases in stage T1, T2, T3, T4 (tumor T staging), cases with vascular invasion, cases with nerve invasion, cases with tumor nodule, cases in stage N0, N1-N2 (tumor N staging), the number of positive lymph node, the number of lymph node dissected, cases with qualified lymph node dissected, cases in stage Ⅰ, Ⅱ, Ⅲ, Ⅳ (TNM clinical staging) were 5.0 cm(3.0 cm, 6.0 cm), 3, 2, 7, 7, 3, 2, 1, 8, 11, 0(0, 4), 17(14, 23), 18, 2, 3, 12, 2 in patients of the glasses-free 3D colorectal cancer group, and 4.0 cm(3.0 cm, 5.0 cm), 7, 16, 43, 12, 14, 12, 7, 46, 32, 0(0, 1), 16(13, 19), 74, 14, 17, 40, 7 in patients of the polarized glasses 3D colorectal cancer group, with no significant difference between the two groups ( Z=-0.768, -1.135, χ2 =0.049, 0.292, 0.278, 1.762, Z=-0.694, -1.349, χ2=0.001, Z=-1.011, P>0.05). (7) Follow-up: 165 patients received follow-up, with out short-term reoperation or postoperative death in the postoperative 30 days. Conclusion:There is no significant difference in the efficacy between glasses-free 3D laparoscopic surgery and polarized glasses 3D laparoscopic surgery for radical resection of gastrointestinal malignant tumors, of which the clinical value requires further study.


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