Comparison of long-term quality of life between Billroth-I and Roux-en-Y anastomosis after distal gastrectomy for gastric cancer: a randomized controlled trial / 中华医学杂志(英文版)

BACKGROUND@#The results of studies comparing Billroth-I (B-I) with Roux-en-Y (R-Y) reconstruction on the quality of life (QoL) are still inconsistent. The aim of this trial was to compare the long-term QoL of B-I with R-Y anastomosis after curative distal gastrectomy for gastric cancer.@*METHODS@#A total of 140 patients undergoing curative distal gastrectomy with D2 lymphadenectomy in West China Hospital, Sichuan University from May 2011 to May 2014 were randomly assigned to the B-I group ( N  = 70) and R-Y group ( N  = 70). The follow-up time points were 1, 3, 6, 9, 12, 24, 36, 48, and 60 months after the operation. The final follow-up time was May 2019. The clinicopathological features, operative safety, postoperative recovery, long-term survival as well as QoL were compared, among which QoL score was the primary outcome. An intention-to-treat analysis was applied.@*RESULTS@#The baseline characteristics were comparable between the two groups. There were no statistically significant differences in terms of postoperative morbidity and mortality rates, and postoperative recovery between the two groups. Less estimated blood loss and shorter surgical duration were found in the B-I group. There were no statistically significant differences in 5-year overall survival (79% [55/70] of the B-I group vs. 80% [56/70] of the R-Y group, P  = 0.966) and recurrence-free survival rates (79% [55/70] of the B-I group vs. 78% [55/70] of the R-Y group, P  = 0.979) between the two groups. The scores of the global health status of the R-Y group were higher than those of the B-I group with statistically significant differences (postoperative 1 year: 85.4 ± 13.1 vs . 88.8 ± 16.1, P  = 0.033; postoperative 3 year: 87.3 ± 15.2 vs . 92.8 ± 11.3, P  = 0.028; postoperative 5 year: 90.9 ± 13.7 vs . 96.4 ± 5.6, P  = 0.010), and the reflux (postoperative 3 year: 8.8 ± 12.9 vs . 2.8 ± 5.3, P  = 0.001; postoperative 5 year: 5.1 ± 9.8 vs . 1.8 ± 4.7, P  = 0.033) and epigastric pain (postoperative 1 year: 11.8 ± 12.7 vs. 6.1 ± 8.8, P  = 0.008; postoperative 3 year: 9.4 ± 10.6 vs. 4.6 ± 7.9, P  = 0.006; postoperative 5 year: 6.0 ± 8.9 vs . 2.7 ± 4.6, P  = 0.022) were milder in the R-Y group than those of the B-I group at the postoperative 1, 3, and 5-year time points.@*CONCLUSIONS@#Compared with B-I group, R-Y reconstruction was associated with better long-term QoL by reducing reflux and epigastric pain, without changing survival outcomes.@*TRIAL REGISTRATION@#ChiCTR.org.cn, ChiCTR-TRC-10001434.

The 10-year outcome and prognostic factors of laparoscopic D 2 radical distal gastrectomy for locally advanced gastric cancer: a CLASS multicenter study / 中华消化外科杂志

Objective:To investigate the 10-year outcome and prognostic factors of laparo-scopic D 2 radical distal gastrectomy for locally advanced gastric cancer. Methods:The retrospec-tive cohort study was conducted. The clinicopathological data of 652 patients with locally advanced gastric cancer who were admitted to 16 hospitals from the multicenter database of laparoscopic gastric cancer surgery in the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group, including 214 cases in the First Affiliated Hospital of Army Medical University, 191 cases in Fujian Medical University Union Hospital, 52 cases in Nanfang Hospital of Southern Medical University, 49 cases in West China Hospital of Sichuan University, 43 cases in Xijing Hospital of Air Force Medical University, 25 cases in Jiangsu Province Hospital of Chinese Medicine, 14 cases in the First Medical Center of the Chinese PLA General Hospital, 12 cases in No.989 Hospital of PLA, 12 cases in the Third Affiliated Hospital of Sun Yat-Sen University, 10 cases in the First Affiliated Hospital of Nanchang University, 9 cases in the First People's Hospital of Foshan, 7 cases in Zhujiang Hospital of Southern Medical University, 7 cases in Fujian Medical University Cancer Hospital, 3 cases in Zhongshan Hospital of Fudan University, 2 cases in Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 2 cases in Peking University Cancer Hospital & Institute, from February 2004 to December 2010 were collected. There were 442 males and 210 females, aged (57±12)years. All patients underwent laparoscopic D 2 radical distal gastrectomy. Observation indicators: (1) surgical situations; (2) postoperative pathological examination; (3) postoperative recovery and complications; (4) follow-up; (5) prognostic factors analysis. Follow-up was conducted by outpatient examination and telephone interview to detect the tumor recurrence and metastasis, postoperative survival of patients up to March 2020. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M( Q1, Q3) or M(range). Count data were described as absolute numbers or percen-tages, and comparison between groups was conducted using the chi-square test. Comparison of ordinal data was analyzed using the rank sum test. The life table method was used to calculate survival rates and the Kaplan-Meier method was used to draw survival curves. Log-Rank test was used for survival analysis. Univariate and multivariate analyses were analyzed using the COX hazard regression model. Results:(1) Surgical situations: among 652 patients, 617 cases underwent D 2 lymph node dissection and 35 cases underwent D 2+ lymph node dissection. There were 348 cases with Billroth Ⅱ anastomosis, 218 cases with Billroth Ⅰ anastomosis, 25 cases with Roux-en-Y anastomosis and 61 cases with other digestive tract reconstruction methods. Twelve patients had combined visceral resection. There were 569 patients with intraoperative blood transfusion and 83 cases without blood transfusion. The operation time of 652 patients was 187(155,240)minutes and volume of intraoperative blood loss was 100(50,150)mL. (2) Postoperative pathological examina-tion: the maximum diameter of tumor was (4.5±2.0)cm of 652 patients. The number of lymph node dissected of 652 patients was 26(19,35), in which the number of lymph node dissected was >15 of 570 cases and ≤15 of 82 cases. The number of metastatic lymph node was 4(1,9). The proximal tumor margin was (4.8±1.6)cm and the distal tumor margin was (4.5±1.5)cm. Among 652 patients, 255 cases were classified as Borrmann type Ⅰ-Ⅱ, 334 cases were classified as Borrmann type Ⅲ-Ⅳ, and 63 cases had missing Borrmann classification data. The degree of tumor differentiation was high or medium in 171 cases, low or undifferentiated in 430 cases, and the tumor differentiation data was missing in 51 cases. There were 123, 253 and 276 cases in pathological stage T2, T3 and T4a, respectively. There were 116, 131, 214 and 191 cases in pathological stage N0, N1, N2 and N3, respectively. There were 260 and 392 cases in pathological TNM stage Ⅱ and Ⅲ, respectively. (3) Postoperative recovery and complications: the time to postoperative first out-of-bed activities, time to postoperative first flatus, time to the initial liquid food intake, duration of postoperative hospital stay of 652 patients were 3(2,4)days, 4(3,5)days, 5(4,6)days, 10(9,13)days, respectively. Among 652 patients, 69 cases had postoperative complications. Clavien-Dindo grade Ⅰ-Ⅱ, grade Ⅲa, grade Ⅲb, and grade Ⅳa complications occurred in 60, 3, 5 and 1 cases, respectively (some patients could have multiple complications). The duodenal stump leakage was the most common surgical complication, with the incidence of 3.07%(20/652). Respiratory complication was the most common systemic complication, with the incidence of 2.91%(19/652). All the 69 patients were recovered and discharged successfully after treatment. (4) Follow-up: 652 patients were followed up for 110-193 months, with a median follow-up time of 124 months. There were 298 cases with postoperative recurrence and metastasis. Of the 255 patients with the time to postoperative recurrence and metastasis ≤5 years, there were 21 cases with distant metastasis, 69 cases with peritoneal metastasis, 37 cases with local recurrence, 52 cases with multiple recurrence and metastasis, 76 cases with recurrence and metastasis at other locations. The above indicators were 5, 9, 10, 4, 15 of the 43 patients with the time to postoperative recurrence and metastasis >5 years. There was no significant difference in the type of recurrence and metastasis between them ( χ2=5.52, P>0.05). Cases in pathological TNM stage Ⅱ and Ⅲ were 62 and 193 of the patients with the time to postoperative recurrence and metastasis ≤5 years, versus 23 and 20 of the patients with the time to postoperative recurrence and metastasis >5 years, showing a significant difference in pathological TNM staging between them ( χ2=15.36, P<0.05). Cases in pathological stage T2, T3, T4a were 42, 95, 118 of the patients with the time to postoperative recurrence and metastasis ≤5 years, versus 9, 21, 13 of the patients with the time to postoperative recurrence and metastasis >5 years, showing no significant difference in pathological T staging between them ( Z=-1.80, P>0.05). Further analysis showed no significant difference in cases in pathological stage T2 or T3 ( χ2=0.52, 2.08, P>0.05) but a significant difference in cases in pathological stage T4a between them ( χ2=3.84, P<0.05). Cases in pathological stage N0, N1, N2, N3 were 19, 44, 85, 107 of the patients with the time to postoperative recurrence and metastasis ≤5 years, versus 12, 5, 18, 8 of the patients with the time to postoperative recurrence and metastasis >5 years, showing a significant difference in pathological N staging between them ( Z=-3.34, P<0.05). Further analysis showed significant differences in cases in pathological stage N0 and N3 ( χ2=16.52, 8.47, P<0.05) but no significant difference in cases in pathological stage N1 or N2 ( χ2=0.85, 1.18, P>0.05). The median overall survival time was 81 months after surgery and 10-year overall survival rate was 46.1% of 652 patients. The 10-year overall survival rates of patients in TNM stage Ⅱ and Ⅲ were 59.6% and 37.5%, respectively, showing a significant difference between them ( χ2=35.29, P<0.05). In further analysis, the 10-year overall survival rates of patients in pathological TNM stage ⅡA, ⅡB, ⅢA, ⅢB and ⅢC were 65.6%, 55.8%, 46.9%, 37.1% and 24.0%, respectively, showing a significant difference between them ( χ2=55.06, P<0.05). The 10-year overall survival rates of patients in patholo-gical stage T2, T3 and T4a were 55.2%, 46.5% and 41.5%, respectively, showing a significant difference between them ( χ2=8.39, P<0.05). The 10-year overall survival rates of patients in patholo-gical stage N0, N1, N2 and N3 were 63.7%, 56.2%, 48.5% and 26.4%, respectively, showing a signifi-cant difference between them ( χ2=54.89, P<0.05). (5) Prognostic factors analysis: results of univariate analysis showed that age, maximum diameter of tumor, degree of tumor differentiation as low or undifferentiated, pathological TNM staging, pathological T staging, pathological stage N2 or N3, post-operative chemotherapy were related factors for the 10-year overall survival rate of locally advanced gastric cancer patients undergoing laparoscopic D 2 radical distal gastrectomy ( hazard ratio=1.45, 1.64, 1.37, 2.05, 1.30, 1.68, 3.08, 0.56, 95% confidence interval as 1.15-1.84, 1.32-2.03, 1.05-1.77, 1.62-2.59, 1.05-1.61, 1.17-2.42, 2.15-4.41, 0.44-0.70, P<0.05). Results of multivariate analysis showed that maximum diameter of tumor >4 cm, low-differentiated or undifferentiated tumor, pathological TNM stage Ⅲ were independent risk factors for the 10-year overall survival rate of locally advanced gastric cancer patients undergoing laparoscopic D 2 radical distal gastrectomy ( hazard ratio=1.48,1.44, 1.81, 95% confidence interval as 1.19-1.84, 1.11-1.88, 1.42-2.30, P<0.05) and postoperative chemotherapy was a independent protective factor for the 10-year overall survi-val rate of locally advanced gastric cancer patients undergoing laparoscopic D 2 radical distal gastrec-tomy ( hazard ratio=0.57, 95% confidence interval as 045-0.73, P<0.05). Conclusions:Laparoscopic assisted D 2 radical distal gastrectomy for locally advanced gastric cancer has satisfactory 10-year oncologic outcomes. A high proportion of patients in pathological TNM stage Ⅲ, pathological stage T4a, pathological stage N3 have the time to postoperative recurrence and metastasis ≤5 years, whereas a high proportion of patients in pathological TNM stage Ⅱ or pathological stage N0 have the time to postoperative recurrence and metastasis >5 years. Maximum diameter of tumor >4 cm, low-differentiated or undifferentiated tumor, pathological TNM stage Ⅲ are independent risk factors for the 10-year overall survival rate of locally advanced gastric cancer patients undergoing laparos-copic D 2 radical distal gastrectomy. Postoperative chemotherapy is a independent protective factor for the 10-year overall survival rate of locally advanced gastric cancer patients undergoing laparos-copic D 2 radical distal gastrectomy.

Influences of age-adjusted Charlson comorbidity index on prognosis of patients undergoing laparoscopic radical gastrectomy: a multicenter retrospective study / 中华消化外科杂志

Objective:To investigate the influences of age-adjusted Charlson comorbidity index (ACCI) on prognosis of patients undergoing laparoscopic radical gastrectomy.Methods:The retrospective cohort study was conducted. The clinicopathological data of 242 gastric cancer patients who underwent laparoscopic radical gastrectomy in 19 hospitals of the Chinese Laparoscopic Gastrointestinal Surgery Study Group-04 study, including 54 patients in Fujian Medical University Union Hospital, 32 patients in the First Hospital of Putian City, 32 patients in Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 31 patients in Zhangzhou Affiliated Hospital of Fujian Medical University, 17 patients in Nanfang Hospital of Southern Medical University, 11 patients in the First Affiliated Hospital with Nanjing Medical University, 8 patients in Qinghai University Affiliated Hospital, 8 patients in Meizhou People′s Hospital, 7 patients in Fujian Provincial Hospital, 6 patients in Zhongshan Hospital of Fudan University, 6 patients in Longyan First Hospital, 5 patients in the First Affiliated Hospital of Xinjiang Medical University, 5 patients in the First Hospital Affiliated to Army Medical University, 4 patients in the Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, 4 patients in West China Hospital of Sichuan University, 4 patients in Beijing University Cancer Hospital, 3 patients in the First Affiliated Hospital of Xiamen University, 3 patients in Guangdong Provincial People′s Hospital, 2 patients in the First Affiliated Hospital of Xi′an Jiaotong University, from September 2016 to October 2017 were collected. There were 193 males and 49 females, aged 62(range, 23?74)years. Observation indicators: (1) age distribution, comorbidities and ACCI status of patients; (2) the grouping of ACCI and comparison of clinicopathological characteristics of patients in each group; (3) incidence of postoperative early complications and analysis of factors affecting postoperative early complications; (4) follow-up; (5) analysis of factors affecting the 3-year recurrence-free survival rate of patients. Follow-up was conducted using outpatient examination or telephone interview to detect postoperative survival of patients up to December 2020. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M( Q1, Q3) or M(range), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Comparison of ordinal data was conducted using the nonparametric rank sum test. The X-Tile software (version 3.6.1) was used to analyze the best ACCI grouping threshold. The Kaplan-Meier method was used to calculate survival rates and draw survival curves. The Log-Rank test was used for survival analysis. The Logistic regression model was used to analyze the factors affecting postoperative early complications. The COX proportional hazard model was used for univariate and multivariate analyses of factors affecting the 3-year recurrence-free survival rate of patients. Multivariate analysis used stepwise regression to include variables with P<0.05 in univariate analysis and variables clinically closely related to prognosis. Results:(1) Age distribution, comor-bidities and ACCI status of patients. Of the 242 patients, there were 28 cases with age <50 years, 68 cases with age of 50 to 59 years, 113 cases with age of 60 to 69 years, 33 cases with age of 70 to 79 years. There was 1 patient combined with mild liver disease, 1 patient combined with diabetes of end-organ damage, 2 patients combined with peripheral vascular diseases, 2 patients combined with peptic ulcer, 6 patients combined with congestive heart failure, 8 patients combined with chronic pulmonary diseases, 9 patients with diabetes without end-organ damage. The ACCI of 242 patients was 2 (range, 0-4). (2) The grouping of ACCI and comparison of clinicopathological characteristics of patients in each group. Results of X-Tile software analysis showed that ACCI=3 was the best grouping threshold. Of the 242 patients, 194 cases with ACCI <3 were set as the low ACCI group and 48 cases with ACCI ≥3 were set as the high ACCI group, respectively. Age, body mass index, cases with preoperative comorbidities, cases of American Society of Anesthesiologists classification as stage Ⅰ, stage Ⅱ, stage Ⅲ, tumor diameter, cases with tumor histological type as signet ring cell or poorly differentiated adenocarcinoma and cases with tumor type as moderately or well differentiated adenocarcinoma, cases with tumor pathological T staging as stage T1, stage T2, stage T3, stage T4, chemotherapy cycles were (58±9)years, (22.6±2.9)kg/m 2, 31, 106, 85, 3, (4.0±1.9)cm, 104, 90, 16, 29, 72, 77, 6(4,6) in the low ACCI group, versus (70±4) years, (21.7±2.7)kg/m 2, 23, 14, 33, 1, (5.4±3.1)cm, 36, 12, 3, 4, 13, 28, 4(2,5) in the high ACCI group, showing significant differences in the above indicators between the two groups ( t=-14.37, 1.98, χ2=22.64, Z=-3.11, t=-2.91, χ2=7.22, Z=-2.21, -3.61, P<0.05). (3) Incidence of postoperative early complications and analysis of factors affecting postoperative early complications. Of the 242 patients, 33 cases had postoperative early complications, including 20 cases with local complications and 16 cases with systemic complica-tions. Some patients had multiple complications at the same time. Of the 20 patients with local complications, 12 cases had abdominal infection, 7 cases had anastomotic leakage, 2 cases had incision infection, 2 cases had abdominal hemorrhage, 2 cases had anastomotic hemorrhage and 1 case had lymphatic leakage. Of the 16 patients with systemic complications, 11 cases had pulmonary infection, 2 cases had arrhythmias, 2 cases had sepsis, 1 case had liver failure, 1 case had renal failure, 1 case had pulmonary embolism, 1 case had deep vein thrombosis, 1 case had urinary infection and 1 case had urine retention. Of the 33 cases with postoperative early complications, there were 3 cases with grade Ⅰ complications, 22 cases with grade Ⅱ complications, 5 cases with grade Ⅲa complications, 2 cases with grade Ⅲb complications and 1 case with grade Ⅳ complica-tions of Clavien-Dindo classification. Cases with postoperative early complications, cases with local complications, cases with systemic complications were 22, 13, 9 in the low ACCI group, versus 11, 7, 7 in the high ACCI group, respectively. There were significant differences in cases with postoperative early complications and cases with systemic complications between the two groups ( χ2=4.38, 4.66, P<0.05), and there was no significant difference in cases with local complications between the two groups ( χ2=2.20, P>0.05). Results of Logistic regression analysis showed that ACCI was a related factor for postoperative early complications of gastric cancer patients undergoing laparoscopic radical gastrectomy [ odds ratio=2.32, 95% confidence interval ( CI) as 1.04-5.21, P<0.05]. (4) Follow-up. All the 242 patients were followed up for 36(range,1?46)months. During the follow-up, 53 patients died and 13 patients survived with tumor. The 3-year recurrence-free survival rate of the 242 patients was 73.5%. The follow-up time, cases died and cases survived with tumor during follow-up, the 3-year recurrence-free survival rate were 36(range, 2-46)months, 29, 10, 80.0% for the low ACCI group, versus 35(range, 1-42)months, 24, 3, 47.4% for the high ACCI group. There was a significant difference in the 3-year recurrence-free survival rate between the two groups ( χ2=30.49, P<0.05). (5) Analysis of factors affecting the 3-year recurrence-free survival rate of patients. Results of univariate analysis showed that preoperative comorbidities, ACCI, tumor diameter, histological type, vascular invasion, lymphatic invasion, neural invasion, tumor pathological TNM staging, postoperative early complications were related factors for postoperative 3-year recurrence-free survival rate of gastric cancer patients undergoing laparoscopic radical gastrectomy [ hazard ratio ( HR)=2.52, 3.64, 2.62, 0.47, 2.87, 1.90, 1.86, 21.77, 1.97, 95% CI as 1.52-4.17, 2.22-5.95, 1.54-4.46, 0.27-0.80, 1.76-4.70, 1.15-3.12, 1.10-3.14, 3.01-157.52, 1.11-3.50, P<0.05]. Results of multivariate analysis showed that ACCI, tumor pathological TNM staging, adjuvant chemotherapy were indepen-dent influencing factors for postoperative 3-year recurrence-free survival rate of gastric cancer patients undergoing laparoscopic radical gastrectomy ( HR=3.65, 11.00, 40.66, 0.39, 95% CI as 2.21-6.02, 1.40-86.73, 5.41-305.69, 0.22-0.68, P<0.05). Conclusions:ACCI is a related factor for post-operative early complications of gastric cancer patients undergoing laparos-copic radical gastrectomy. ACCI, tumor pathological TNM staging, adjuvant chemotherapy are indepen-dent influencing factors for postoperative 3-year recurrence-free survival rate of gastric cancer patients undergoing laparoscopic radical gastrectomy.

Current status and challenges of neoadjuvant therapy in gastric cancer / 中华消化外科杂志

In recent years, neoadjuvant therapy, which can reduce the tumor stage, increase the surgical resection rate and the proportion of radical resection, reduce the risk of tumor recurrence and metastasis thus bringing survival benefit for local advanced gastric cancer patients, plays increasingly important roles in the comprehensive treatment of gastric cancer. In China, the early diagnosis rate of gastric cancer is particularly low and most patients with gastric cancer are diagnosed as locally advanced. Therefore, it is of crucial importance to discuss the current status and challenges of neoadjuvant therapy in gastric cancer. Combined with the existing clinical research results and guidelines and consensus, the authors analyze the application of neoadjuvant therapy in the comprehensive treatment of gastric cancer. Currently, more high-quality clinical trials are still needed to answer the questions related to neoadjuvant therapy of gastric cancer, such as the indication and regimen, and the optimal cycles and doses of agents, combination of targeted therapy or immunotherapy. Furthermore, how to tailor the individualized treatment strategies according to the pathological stages, molecular characteristics and gene polymophism of patients are still the problems unsolved nowadays. The authors comprehensively analyze the literature at home and abroad to deeply explore the current status and challenges of neoadjuvant therapy in gastric cancer.

The methodological framework of surgical innovation: the introduction of IDEAL framework and recommendation / 中国胸心血管外科临床杂志

@#Surgical innovation is an important part of surgical research and practice. The evaluation of surgical innovation through the stages is similar to those for drug development, but with important differences. The Idea, Development, Exploration, Assessment, and Long-term follow-up (IDEAL) Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009. The IDEAL is a five-stage framework involving the nature stages of surgical innovation, together with recommendations for surgical research pathway. The Framework and Recommendations were updated and published in 2019, which added a pre-IDEAL stage if necessary. The updated IDEAL also underlines the purpose, key question and ethical issues for each stage. In the first paper of IDEAL Framework and Recommendations series, we conducted a comprehensive introduction of IDEAL (e.g. the development, updates and application of IDEAL) to promote the dissemination and application of IDEAL in China.

The methodological framework of surgical innovation: The interpretation of IDEAL reporting guideline / 中国胸心血管外科临床杂志

@#Adherence to reporting guidelines contributes to report methodology and outcomes of research distinctly and transparently. There are some checklists with specific study types related to surgery on the EQUATOR Network’s website. However, the IDEAL framework focuses on stepwise evaluation of surgical innovation through all stages with some key elements, which those existing guidelines may not mention. This likely results in the inaccuracy in reporting in studies attempting to follow the IDEAL recommendations and suggests a pressing need for IDEAL reporting guidelines. Considering these limitations, the IDEAL developed the IDEAL reporting guidelines between October 2018 and May 2019. The paper aimed to provide interpretation of IDEAL reporting guideline, and promote its understanding and use among Chinese researchers.

Standards of surgical clinical researches: Introduction of IDEAL framework / 中华胃肠外科杂志

Many breakthroughs in the field of surgical clinical researches have been achieved in China, but the overall quality is relatively limited, largely because of the insufficiency in standardization, rationality and scientificity of methodology. In consideration of the nature of surgical procedures and equipments, it is necessary to establish a set of methodological system, suitable for the high-quality clinical research in the surgical field. IDEAL collaboration has put forward a systematic methodological framework for innovation in surgical procedure and equipment. For the clinical research on surgical innovation, the IDEAL framework can be divided into five sequential stages, namely, Idea, Development, Exploration, Assessment and Long-term follow-up. In different stages, the difficulties to be faced, the problems to be solved, and the research design to be adopted are diverse and progressive. Although the IDEAL framework is not perfect, it is currently the best framework for surgical clinical research. While performing surgical clinical research, we should continue to think about how to improve the surgical clinical research methodology.

Prevention and treatment of anastomosis-related complications after gastric cancer surgery / 中华消化外科杂志

Postoperative anastomosis-related complications are the common postoperative complications of gastric cancer. With the advancement of surgical technology and surgical instruments, the risk of postoperative anastomosis-related complications of gastric cancer has been greatly reduced. However, anastomotic stenosis, residual gastritis, anastomosis inflammation and reflux esophagitis seriously affect long-term quality of life in gastric cancer patients. Based on the incidence of short-term and long-term complications, the authors aim to conclude risks factors, preventive measures and means of treatment for postoperative anastomosis-related complications after gastric cancer surgery.

Supra-pancreatic lymph node dissection with the surgeon on right position in 4K laparoscopic radical gastrectomy / 中华消化外科杂志

As the same safety and oncologic effect of open gastrectomy, laparoscopic radical gastrectomy has been widely used in the treatment of gastric cancer. Supra-pancreatic lymph node dissection is the key and difficult prospect in laparoscopic radical gastrectomy for gastric cancer. The authors investigate the indication, operative preparation, boundary of supra-pancreatic lymph nodes and dissected standard, surgical complication of 4K laparoscopic radical gastrectomy, and described the experience and operative procedures of supra-pancreatic lymph node dissection with the surgeon on right position.

Extent of lymph node dissection and interpretation of technical standards for 4K laparoscopic proximal gastrectomy in gastric cancer / 中华消化外科杂志

Laparoscopic gastrectomy has been widely applied in the surgical treatment for gastric cancer. The indications of laparoscopic gastrectomy for gastric cancer are also expanding. Based on the results of CLASS-01 study, laparoscopic distal gastrectomy is one of standard recommended surgical procedures for locally advanced gastric cancer. With the increased incidence of proximal gastric cancer and adenocarcinoma of esophagogastric junction, the proportion of total and proximal gastrectomy is gradually increasing. However, in consideration of tumor recurrence risk and severe gastroesophageal reflux symptoms after operation, the indication for proximal gastrectomy is more rigorous. Considering the minimally invasive advantage of laparoscopy, laparoscopic proximal gastrectomy is still an alternative surgical method for patients with surgical indications. It is well known that lymphadenectomy is the key procedure in stan-dard radical gastrectomy for gastric cancer. According to the Japanese gastric cancer treatment guideline of Japanese Gastric Cancer Association (JACA), the standard surgery of proximal gastrectomy is proximal gastrectomy combined with D 1 (No.1, 2, 3a, 4sa, 4sb, 7) or D 1+ (D 1+ No.8a, 9, 11p) lymphadenectomy. The authors describe the extent and procedure of lymphadenectomy and interpret technical standards for laparoscopic proximal gastrectomy.

Supra-pancreatic lymph node dissection with the surgeon on right position in 4K laparoscopic radical gastrectomy / 中华消化外科杂志

As the same safety and oncologic effect of open gastrectomy, laparoscopic radical gastrectomy has been widely used in the treatment of gastric cancer. Supra-pancreatic lymph node dissection is the key and difficult prospect in laparoscopic radical gastrectomy for gastric cancer. The authors investigate the indication, operative preparation, boundary of supra-pancreatic lymph nodes and dissected standard, surgical complication of 4K laparoscopic radical gastrectomy, and described the experience and operative procedures of supra-pancreatic lymph node dissection with the surgeon on right position.

Extent of lymph node dissection and interpretation of technical standards for 4K laparoscopic proximal gastrectomy in gastric cancer / 中华消化外科杂志

Laparoscopic gastrectomy has been widely applied in the surgical treatment for gastric cancer. The indications of laparoscopic gastrectomy for gastric cancer are also expanding. Based on the results of CLASS-01 study, laparoscopic distal gastrectomy is one of standard recommended surgical procedures for locally advanced gastric cancer. With the increased incidence of proximal gastric cancer and adenocarcinoma of esophagogastric junction, the proportion of total and proximal gastrectomy is gradually increasing. However, in consideration of tumor recurrence risk and severe gastroesophageal reflux symptoms after operation, the indication for proximal gastrectomy is more rigorous. Considering the minimally invasive advantage of laparoscopy, laparoscopic proximal gastrectomy is still an alternative surgical method for patients with surgical indications. It is well known that lymphadenectomy is the key procedure in stan-dard radical gastrectomy for gastric cancer. According to the Japanese gastric cancer treatment guideline of Japanese Gastric Cancer Association (JACA), the standard surgery of proximal gastrectomy is proximal gastrectomy combined with D 1 (No.1, 2, 3a, 4sa, 4sb, 7) or D 1+ (D 1+ No.8a, 9, 11p) lymphadenectomy. The authors describe the extent and procedure of lymphadenectomy and interpret technical standards for laparoscopic proximal gastrectomy.

Infrapyloric lymph node dissection in gastric cancer radical surgery under the guidance of mesenteric anatomy theory / 中华胃肠外科杂志

The most common metastasis modality of gastric cancer is the perigastric lymph node metastasis. Complete dissection of regional lymph nodes of the stomach is the core surgical treatment strategy of gastric cancer, and is closely related to the prognosis of gastric cancer patients. Infrapyloric lymph node metastasis is common in gastric cancer,and its incomplete dissection is associated with tumor recurrence. Meanwhile, anatomical variations of vessels and complex mesentery layers of infrapyloric area increase the difficulty of lymphadenectomy during the operation. So, infrapyloric lymph node (No. 6) is an important station. Based on the theory of embryonic development and complete mesogastrium excision, operation across the anatomical space among mesentery layers can ensure en bloc resection of the infrapyloric lymph nodes.

Comparison of safety and efficacy between proximal gastrectomy and total gastrectomy for upper third gastric cancer: a Meta-analysis / 中华胃肠外科杂志

Objective@#To compare the safety and efficacy between proximal gastrectomy and total gastrectomy and to ascertain the optimized procedure for patients with upper third gastric cancer through meta-analysis.@*Methods@#The English literatures about proximal gastrectomy and total gastrectomy for upper third gastric cancer were searched from PubMed, EMBASE, the Cochrane Library and the Web of Science database and then collected. The quality of enrolled studies was independently assessed by two researchers according to the Newcastle-Ottawa Scale for retrospective studies and Jadad scale for RCT studies. The basic information of the literature and related clinical indicators were extracted. The primary endpoints were 5-year overall survival rate and recurrence rate. The secondary endpoints were operative time, intraoperative blood loss, morbidity of postoperative complication, incidence of anastomotic stenosis and incidence of reflux esophagitis. Considering the influence of tumor staging on postoperative clinicopathological features and prognosis, a subgroup analysis was performed on the literatures including cases of early gastric cancer and those including cases of tumor stage I to IV. Statistical analyses were carried out by the "metafor" and "meta" software packages from RevMan 5.3 software and R software (V3.2.4).@*Results@#Twenty-five literatures involving 3667 patients (proximal gastrectomy for 1483, total gastrectomy for 2184) were finally enrolled for analysis, including 24 retrospective studies with ≥ 5 points and 1 RCT with 3 points, and all the literatures were of high quality. A total of 2516 cases of early gastric cancer were enrolled in 18 articles, including 1027 with proximal gastrectomy and 1489 with total gastrectomy. A total of 1151 cases with stage I to IV were enrolled in 7 articles, including 456 in proximal gastrectomy group and 695 in total gastrectomy group. Five-year survival rate was not significantly different for patients with early gastric cancer between the proximal gastrectomy group and total gastrectomy group (OR=1.16, 95% CI: 0.72 to 1.86, P=0.54). Similarly, there was no significant difference for patients with stage I to IV between the proximal gastrectomy group and the total gastrectomy group (OR=1.19, 95% CI: 0.92 to 1.53, P=0.18). Recurrence rate of early gastric cancer patients was not significantly different between the proximal gastrectomy group and the total gastrectomy group (OR=0.40, 95% CI: 0.05 to 3.16, P=0.39).However, the recurrence rate of the proximal gastrectomy group was higher than that of the total gastrectomy group in patients with stage I to IV (OR=1.55, 95% CI: 1.09 to 2.19, P<0.01), whose difference was statistically significant. There was no significant differences in postoperative complication between the groups, both in patients with early gastric cancer, and in those with stage I to IV (both P>0.05). The incidences of postoperative anastomotic stenosis (OR=3.57, 95% CI: 1.82 to 6.99, P<0.01) and reflux esophagitis (OR=2.83, 95% CI: 1.23 to 6.54, P=0.01) in the proximal gastrectomy group were significantly higher than those in the total gastrectomy group in patients with early gastric cancer.@*Conclusions@#There is no significant difference in long-term survival outcomes between total gastrectomy and proximal gastrectomy for upper gastric tumors. However,incidence of anastomotic stenosis and reflux esophagitis, and tumor recurrence rate after total gastrectomy are significantly lower. The total gastrectomy is recommended as the first choice for advanced upper gastric tumor.

Interpretation of Chinese expert consensus on the surgical treatment for adenocarcinoma of esophagogastric junction (2018 edition) / 中华胃肠外科杂志

The surgical treatment for adenocarcinoma of esophagogastric junction (AEG) involves thoracic and abdominal cavities. With no general consensus on the surgical treatment modality for AEG in China, the understanding and surgical practice of AEG are controversial between thoracic and gastrointestinal surgeons. Chinese expert consensus on the surgical treatment for adenocarcinoma of esophagogastric junction (2018 edition) was released in September 2018 by the Chinese expert panel including 19 thoracic surgeons and 20 gastrointestinal surgeons. The formulation and publication of this consensus has increased homogeneity of the understanding of the disease in different disciplines to a certain extent, and has facilitated standardized surgical treatment for adenocarcinoma of esophagogastric junction. The consensus was based on the best available clinical evidence and the latest national and international guidelines and consensus. Several rounds of discussion and voting were conducted. Finally, 27 statements on surgery-related recommendations and 9 issues requiring further investigation were reached in the consensus, which basically cover the fields and research hotspots of surgical treatment for adenocarcinoma of esophagogastric juncton. This review will explain in details the Chinese expert consensus on the surgical treatment for adenocarcinoma of esophagogastric junction.

How to perform a real world clinical study of surgery / 中华胃肠外科杂志

With the development of the methodology of clinical trials and the appearance of medical big data, the real-world study (RWS) presents its unique advantages, plays a role in clinical practice and research, and its importance is more and more recognized by scholars in recent years. In surgical research field, due to the specificity of surgical diseases and operational procedures, confounding factors and risk of bias are greatly higher than those of traditional medications. Therefore, using unique advantages of the RWS to solve the actual clinical problem in surgical field is the main goal of performing surgical RWS. This article will systematically elucidate how to perform the surgical RWS and the special matters of concern in carrying out surgical RWS.

Laparoscopic gastrectomy combined with neoadjuvant chemotherapy for gastric cancer patients: from the view of the CLASS-03a trial / 中华胃肠外科杂志

Neoadjuvant chemotherapy combined with radical gastrectomy is one of the most important parts of the multimodality therapy strategies for locally advanced gastric cancer. With the development of laparoscopic technique in recent decades, laparoscopic technique plays a more and more important role in the surgical treatment of gastric cancer. Neoadjuvant chemotherapy, as a part of comprehensive treatment of gastric cancer, has gained more and more clinical supports and been recommended for guidelines. With the development of laparoscopic technique and clinical evidence, laparoscopic operation for advanced gastric cancer has been applied more and more widely. However, the safety and efficacy of laparoscopic resection following neoadjuvant chemotherapy, as a new treatment modality, still needs prospectively high-level researches to verify. Therefore, we will discuss some key points of laparoscopic gastrectomy after neoadjuvant chemotherapy based on the CLASS 03a trial, which is led by the Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, the Department of Gastrointestinal Surgery, Peking University Cancer Hospital and Institute, and Chinese Laparoscopic Gastric Surgery Study Group. The CLASS 03a trial aims to confirm surgical and oncological safety of laparoscopy distal D2 radical gastrectomy for locally advanced stage gastric cancer patients (cT3~4a, N-/+, M0) who completed neoadjuvant chemotherapy. On the base of CLASS 03a trial, this article elucidates the choice of neoadjuvant chemotherapy for gastric cancer and proposes some associated problems about neoadjuvant chemotherapy combined with laparoscopic gastric cancer operation.

Establishment and preliminary application of tissue response grading system following neoadjuvant chemotherapy / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To establish the tissue response grading (TRG) system following neoadjuvant chemotherapy and to investigate its application in the gastric cancer patients who received neoadjuvant chemotherapy.</p><p><b>METHODS</b>Data of 30 cT3-4N0-3M0 gastric cancer cases who received neoadjuvant chemotherapy and operation from May 2017 to February 2018 at Department of Gastrointestinal Surgery, West China Hospital were analyzed retrospectively. The edema degree of gastrointestinal tract and perigastric tissues, intraoperative effusion, and fibrosis of tumor and lymph nodes bearing tissues which could be divided into 4 categories constituted the core parameters of the TRG system following neoadjuvant chemotherapy. Four categories of edema: grade 0, no obvious tissue edema; grade 1, slight tissue edema and swelling, no obvious effusion when dissecting the capsule of connective tissues; grade 2, moderate tissue edema and swelling, a few effusion when dissecting the capsule of connective tissues; grade 3, severe tissue edema and swelling with high tension on the capsule of connective tissues, tension blister could be observed in some patients, continuous effusion when dissecting the capsule of connective tissues. Four categories of intraoperative effusion: grade 0, no obvious effusion; grade 1, slight effusion and a few intraperitoneal exudation; grade 2, moderate effusion and continuous intraperitoneal exudation necessitating interrupted suction; grade 3, severe effusion and continuous intraperitoneal exudation necessitating constant suction. Four categories of fibrosis: grade 0, no fibrosis; grade 1, slight fibrosis with threadiness fibrous bands, clear dissecting space could be found between the fibrous tissues and adventitia/normal tissues; grade 2, moderate fibrosis with flaky fibrous tissues, the difficulty of tissue and lymph nodes dissection increased although dissecting space could be found between the fibrous tissues and adventitia/normal tissues; grade 3, severe fibrosis with hard and flaky fibrous membrane, the difficulty of tissue and lymph nodes dissection increased extremely and the fibrous tissues merges with adventitia/normal tissues without dissecting space. The relationships of TRG system with tumor response evaluation by computed tomography (CT), tumor regression score, surgical duration, number of retrieved lymph nodes, number of metastatic lymph nodes, number of enlarged lymph nodes seen in the preoperative CT scans as well as postoperative complications were analyzed using t test, χ² test and logistic regression model.</p><p><b>RESULTS</b>Nineteen male and 11 female patients with a mean age of(59.1±9.4) years were enrolled. There were 17 cases of grade 1, 12 cases of grade 2 and 1 case of grade 3 for tissue edema, while the corresponding number was 14, 15 and 1 for intraoperative effusion and 15, 14 and 1 for fibrosis respectively. There were no significant differences among the different degrees of tissue edema, intraoperative effusion and fibrosis in terms of the tumor response evaluation by CT and tumor regression score (all P>0.05). The results of logistics regression showed that tumor response evaluation by CT was related with the degree of tissue edema (P=0.012) and intraoperative effusion (P=0.007), rather than the degree of fibrosis (P=0.527). However, tumor regression score was not related with the degree of tissue edema(P=0.345), intraoperative effusion (P=0.159) and fibrosis (P=0.207). Surgical duration of one case with all grade 3 in tissue edema, intraoperative effusion and fibrosis was 408 minutes, which was longer than those with grade 1 and grade 2 patients [(295.9±40.1) minutes and (293.1±34.3) minutes, respectively]; the number of retrieved lymph nodes, metastatic lymph nodes, and enlarged lymph nodes seen in the preoperative CT scans of this case with all grade 3 were 25, 4 and 1, which were all less than those with grade 1 and grade 2 (42.3±11.9 and 38.5±18.2, 7.3±9.1 and 8.1±9.7, 1.8±1.6 and 2.3±1.3, respectively). There were no significant differences between grade 1 and grade 2 of tissue edema, intraoperative effusion and fibrosis in terms of surgical duration, retrieved lymph nodes, metastatic lymph nodes and enlarged lymph nodes seen in the preoperative CT scans(all P>0.05). Four patients suffered from pulmonary complications and 2 patients experienced slight lymphatic, and all leakage were cured by conservative therapies. There were no significant differences among the different grades of tissue edema, intraoperative effusion and fibrosis in terms of the operation-associated complications (all P>0.05).</p><p><b>CONCLUSION</b>The tissue response grading system can assist the judgment of operation difficulty and reflect the effectiveness of neoadjuvant chemotherapy to some extent, which has the possibility of applications.</p>

Chinese expert consensus on the surgical treatment for adenocarcinoma of esophagogastric junction (2018 edition) / 中华胃肠外科杂志

Incidence of adenocarcinoma of esophago-gastric junction (AEG) in China presents an obviously increasing trend. Due to the particular anatomic site, its definition, classification, staging, surgical approach, resection pattern, extent of lymphadenectomy, and neoadjuvant therapy, etc. remain controversial. The goal of this expert consensus is to improve the homogeneity in understanding and practice among Chinese thoracic and gastrointestinal surgeons, and to further standardize surgical treatment of AEG. This consensus was generated based on the best available clinical evidence, the latest global guidelines or consensuses, and the agreement from the Chinese expert panel. The panel composed of 19 thoracic surgeons and 20 gastrointestinal surgeons nationwide. Delphi technique was used to generate agreement rates and revision details. In the fields of aforementioned controversies, the present consensus produced 27 statements on surgical treatment-related recommendations for AEG, as well as 9 issues as investigational surgical concerns. The present consensus consists of 7 parts:(1) definition and classification of AEG; (2) surgical approach; (3) minimally invasive surgery; (4) pattern and extent of resection; (5) combined organ resection; (6) lymph node group and lymphadenectomy standard; and(7) neoadjuvant therapy. Pending issues in this consensus need further high-quality clinical research.

Surgical site infection following abdominal surgery in China: a multicenter cross-sectional study / 中华胃肠外科杂志

OBJECTIVE@#To determine the incidence of surgical site infection (SSI) after abdominal surgery and to further evaluate the related risk factors of SSI in China.@*METHODS@#The multicenter cross-sectional study collected clinical data of all adult patients who underwent abdominal surgery from May 1, 2018 to May 31, 2018 in 30 domestic hospitals, including basic information, perioperative parameters, and incisional microbial culture results. The primary outcome was the incidence of SSI within postoperative 30 days. SSI was classified into superficial incision infection, deep incision infection, and organ/gap infection according to the US Centers for Disease Control and Prevention (CDC) criteria. The secondary outcome variables were ICU stay, postoperative hospital stay, total hospital stay, 30-day mortality and treatment costs. Multivariate logistic regression was used to analyze the risk factors of SSI.@*RESULTS@#A total of 1666 patients were enrolled in the study, including 263 cases of East War Zone Hospital of PLA, 140 cases of Affiliated Hospital of Qingdao University, 108 cases of The First Affiliated Hospital of Nanchang University, 87 cases of Central War Zone Hospital of PLA, 77 cases of West China Hospital, 74 cases of Guangdong General Hospital, 71 cases of Chenzhou First People's Hospital, 71 cases of Zigong First People's Hospital, 64 cases of Zhangjiagang First People's Hospital, 56 cases of Nanyang City Central Hospital, 56 cases of Lanzhou General Hospital of Lanzhou Military Command, 56 cases of Shandong Provincial Hospital, 52 cases of Shangqiu First People's Hospital, 52 cases of People's Hospital of Xinjiang Uygur Autonomous Region, 48 cases of The Second Xiangya Hospital of Central South University, 48 cases of Chinese PLA General Hospital, 44 cases of Affiliated Hospital of Xuzhou Medical University, 38 cases of Hunan Province People's Hospital, 36 cases of Dongguan Kanghua Hospital, 30 cases of Shaoxing Central Hospital, 30 cases of Northern Jiangsu People's Hospital, 29 vases of The First Affiliated Hospital of Zhengzhou University, 27 cases of General Hospital of Tianjin Medical University, 22 cases of Zigong Fourth People's Hospital, 21 cases of The Second Hospital of University of South China, 18 cases of Tongji Hospital, 15 cases of Nanchong Central Hospital, 12 cases of The 901th Hospital of PLA, 11 cases of Hunan Cancer Hospital, 10 cases of Lanzhou University Second Hospital. There were 1019 males and 647 females with mean age of (56.5±15.3) years old. SSI occurred in 80 patients (4.8%) after operation, including 39 cases of superficial incision infection, 16 cases of deep incision infection, and 25 cases of organ/interstitial infection. Escherichia coli was the main pathogen of SSI, and the positive rate was 32.5% (26/80). Compared with patients without SSI, those with SSI had significantly higher ICU occupancy rate [38.8%(31/80) vs. 13.9%(220/1586), P<0.001], postoperative hospital stay (median 17 days vs. 7 days, P<0.001) and total hospital stay (median 22 days vs. 13 days, P<0.001), and significantly higher cost of treatment (median 75 000 yuan vs. 44 000 yuan, P<0.001). Multivariate analysis showed that male rise(OR=2.110, 95%CI:1.175-3.791, P=0.012), preoperative blood glucose level rise(OR=1.100, 95%CI: 1.012-1.197, P=0.026), operative time (OR=1.006, 95%CI:1.003-1.009, P<0.001) and surgical incision grade (clean-contaminated incision:OR=10.207, 95%CI:1.369-76.120, P=0.023; contaminated incision: OR=10.617, 95%CI:1.298-86.865, P=0.028; infection incision: OR=20.173, 95%CI:1.768-230.121, P=0.016) were risk factors for SSI; and laparoscopic surgery (OR=0.348, 95%CI:0.192-0.631, P=0.001) and mechanical bowel preparation(OR=0.441,95%CI:0.221-0.879, P=0.020) were protective factors for SSI.@*CONCLUSIONS@#The incidence of postoperative SSI in patients with abdominal surgery in China is 4.8%. SSI can significantly increase the medical burden of patients. Preoperative control of blood glucose and mechanical bowel preparation are important measures to prevent SSI.