Safety and short-term outcomes of a modified valvuloplastic esophagogastrostomy versus gastric tube anastomosis after laparoscopy-assisted proximal gastrectomy: a retrospective cohort study.

BACKGROUND: There is no optimal reconstruction method after proximal gastrectomy. The valvuloplastic esophagogastrostomy can reduce postoperative reflux esophagitis, but it is technically complex with a long operation time. The gastric tube anastomosis is technically simple, but the incidences of reflux esophagitis and anastomotic stricture are higher. METHODS: We have devised a modified valvuloplastic esophagogastrostomy after laparoscopy-assisted proximal gastrectomy (LAPG), the arch-bridge anastomosis. After reviewing our prospectively maintained gastric cancer database, 43 patients who underwent LAPG from November 2021 to April 2023 were included in this cohort study, with 25 patients received the arch-bridge anastomosis and 18 patients received gastric tube anastomosis. The short-term outcomes were compared between the two groups to evaluate the efficacy of the arch-bridge anastomosis. Reporting was consistent with the STROCSS 2021 guideline. RESULTS: The median operation time was 180 min in the arch-bridge group, significantly shorter than the gastric tube group (p = 0.003). In the arch-bridge group, none of the 25 patients experienced anastomotic leakage, while one patient (4%) experienced anastomotic stricture requiring endoscopic balloon dilation. The postoperative length of stay was shorter in the arch-bridge group (9 vs. 11, p = 0.034). None of the patients in the arch-bridge group experienced gastroesophageal reflux and used proton pump inhibitor (PPI), while four (22.2%) patients in the gastric tube group used PPI (p = 0.025). The incidence of reflux esophagitis (Los Angeles grade B or more severe) by endoscopy was lower in the arch-bridge group (0% vs. 25.0%). CONCLUSION: The arch-bridge anastomosis is a safe, time-saving, and feasible reconstruction method. It can reduce postoperative reflux and anastomotic stricture incidences in a selected cohort of patients undergoing laparoscopy-assisted proximal gastrectomy.

A modified esophagogastric reconstruction method after laparoscopic proximal gastrectomy: A technical note with video vignette.

TECHNIQUE: Although the double flap technique effectively reduces the incidence of postoperative reflux esophagitis and anastomotic leakage after laparoscopic gastrectomy, its clinical application is restricted because the procedure is technical complex. We devised a modified esophagogastric reconstructive method which we termed the "arch-bridge-type" reconstruction. This reconstruction method was performed for a 71-year-old man, who was admitted to our hospital with the diagnosis of cT2N0 upper gastric cancer. The present study reported the surgical details and accompanied with the video. RESULTS: The patient underwent surgery successfully without switching to open surgery. The total operation time was 203 min, the time for making the "arch-bridge" was 16 min, and the time for esophagogastric anastomosis under laparoscopy was 23 min. No surgery-related complications occurred. The postoperative hospital stay was 10 days. The upper GI radiography demonstrated that the anastomosis was not narrow and no extravasation of contrast agent was observed. The gastroscopy found no reflux esophagitis and anastomotic stenosis 1 year after surgery. CONCLUSION: The "arch-bridge-type" reconstruction method is safe and time saving. It has advantages in simplifying the procedure of conventional double flap technique and reducing postoperative complications after proximal gastrectomy.

Pre- and Post-treatment Double-Sequential-Point Dynamic Radiomic Model in the Response Prediction of Gastric Cancer to Neoadjuvant Chemotherapy: 3-Year Survival Analysis.

BACKGROUND: Prognosis prediction of patients with gastric cancer after neoadjuvant chemotherapy is suboptimal. This study aims to develop and validate a dynamic radiomic model for prognosis prediction of patients with gastric cancer on the basis of baseline and posttreatment features. PATIENTS AND METHODS: This single-center cohort study included patients with gastric adenocarcinoma treated with neoadjuvant chemotherapy from June 2009 to July 2015 in the Gastrointestinal Cancer Center of Peking University Cancer Hospital. Their clinicopathological data, pre-treatment and post-treatment computed tomography (CT) images, and pathological reports were retrieved and analyzed. Four prediction models were developed and validated using tenfold cross-validation, with death within 3 years as the outcome. Model discrimination was compared by the area under the curve (AUC). The final radiomic model was evaluated for calibration and clinical utility using Hosmer-Lemeshow tests and decision curve analysis. RESULTS: The study included 205 patients with gastric adenocarcinoma [166 (81%) male; mean age 59.9 (SD 10.3) years], with 71 (34.6%) deaths occurring within 3 years. The radiomic model alone demonstrated better discrimination than the pathological T stage (ypT) stage model alone (cross-validated AUC 0.598 versus 0.516, P = 0.009). The final radiomic model, which incorporated both radiomic and clinicopathological characteristics, had a significantly higher cross-validated AUC (0.769) than the ypT stage model (0.516), the radiomics alone model (0.598), and the ypT plus other clinicopathological characteristics model (0.738; all P < 0.05). Decision curve analysis confirmed the clinical utility of the final radiomic model. CONCLUSIONS: The developed radiomic model had good accuracy and could be used as a decision aid tool in clinical practice to differentiate prognosis of patients with gastric cancer.

Efficacy of chemotherapy versus surgery as initial treatment for gastric cancer with positive peritoneal cytology.

BACKGROUND: The prognosis of gastric cancer (GC) patients with positive peritoneal cytology (CY1) without other distant metastasis is poor, and there are no standard treatment strategies. Our study aimed to compare the survival outcomes of CY1 GC patients receiving chemotherapy or surgery as initial treatment. METHODS: From February 2017 to January 2020, clinical and pathological data of patients diagnosed with CY1 GC without other distant metastasis in the Peking University Cancer Hospital was reviewed. Patients were divided into two groups: chemotherapy-initial group and surgery-initial group. In chemotherapy-initial group, patients received preoperative chemotherapy initially. According to the treatment response, the patients were divided into three subgroups: conversion gastrectomy group, palliative gastrectomy group, and further systematic chemotherapy group. In surgery-initial group, patients underwent gastrectomy followed by postoperative chemotherapy. RESULTS: A total of 96 CY1 GC patients were included with 48 patients in each group. In chemotherapy-initial group, preoperative chemotherapy yielded an objective response rate of 20.8% and disease control rate of 87.5%. Conversion to CY0 after preoperative chemotherapy was obtained in 24 (50%) patients. The median overall survival was 36.1 months in chemotherapy-initial group and 29.7 months in surgery-initial group (p = 0.367). The median progression-free survival was 18.1 months in chemotherapy-initial group and 16.1 months in surgery-initial group (p = 0.861). The 3-year overall survival rates were 50.0% and 47.9%, respectively. In chemotherapy-initial group, twenty-four patients who converted to CY0 by preoperative chemotherapy and received surgery obtained a significantly better prognosis. The median overall survival was still not reached in these patients. CONCLUSION: There was no significant difference in survival outcomes between chemotherapy-initial group and surgery-initial group. CY1 GC patients who converted to CY0 by preoperative chemotherapy and received radical surgery could obtain a favorable long-term prognosis. Further investigation should focus on preoperative chemotherapy to eliminate peritoneal cancer cell. TRIAL REGISTRATION: This study is retrospectively registered.

Efficacy and safety of preoperative immunotherapy alone followed by surgery in the treatment of advanced gastric cancer with MSI-H/dMMR or EBV-positive.

BACKGROUND: At present, there is no consensus on whether preoperative immunotherapy (PIT) without chemotherapy followed by surgery could benefit patients with advanced gastric cancer (AGC). Here, we report a six-case series study to describe the safety and efficacy of PIT plus gastrectomy in patients with AGC. METHODS: This study involved six patients with AGC who received PIT and surgery at our center between January 2019 and July 2021. Demographic characteristics, preoperative gastroscope biopsy pathology, surgical tissue pathology, radicalness of tumor resection, surgical safety, and recovery parameters were reported. RESULTS: Six patients, including four patients with Epstein-Barr virus (EBV)-positive gastric cancer (GC) and two patients with microsatellite instability-high (MSI-H)/expression deficiency of mismatch repair (dMMR) protein GC, were enrolled in this study. Four patients experienced immunotherapy-related adverse events (irAEs), without severe adverse events (SAEs). Five patients underwent R0 resection, and one patient underwent palliative gastrectomy due to liver and hilar lymph node metastasis. Pathologic responses from the surgical tissue were observed in all patients, including two pathological complete response (pCR). No operative complications or postoperative deaths occurred. Three patients (50%) experienced mild or moderate postoperative complications without severe postoperative complications. All six patients eventually recovered and were discharged. CONCLUSION: This study indicated that PIT was effective and tolerant in some patients with MSI-H/dMMR and/or EBV-positive AGC. PIT followed by gastrectomy might be an alternative treatment option for these selected patients.

Safety and short-term outcomes of gastrectomy after preoperative chemotherapy plus immunotherapy versus preoperative chemotherapy: a retrospective cohort study.

BACKGROUND: The safety and short-term outcomes of gastrectomy after preoperative chemotherapy plus immunotherapy (PCIT) versus preoperative chemotherapy (PCT) in patients with advanced gastric cancer (AGC) remain unclear. This study was conducted to compare the safety and short-term efficacy of PCIT with those of PCT in patients with AGC. METHODS: We retrospectively reviewed the data of patients with AGC who received PCIT or PCT at Peking University Cancer Hospital and Institute Gastrointestinal Cancer Center I between January 2019 and June 2021. The clinical characteristics were recorded, and short-term oncological outcomes were compared. Independent t tests, Mann‒Whitney U tests, chi-square tests, and Fisher's exact tests were used to calculate differences. The correlation analyses were performed using Pearson correlation. All p values were two-sided, and a p value < 0.05 was considered statistically significant. All the above statistical analyses were conducted by the SPSS version 24.0 software package (IBM Corp., Armonk, NY, USA). RESULTS: A total of 162 AGC patients were included in this study, including 25 patients who received PCIT and 137 patients who received PCT. There were no significant differences in preoperative treatment-related adverse events (TRAEs) between the PCIT group and the PCT group (p = 0.088). Compared with the PCT group, the PCIT group had comparable postoperative functional recovery, with no significant differences in terms of time to first aerofluxus (p = 0.349), time to first defecation (p = 0.800), time to liquid diet (p = 0.233), or length of stay (p = 0.278). No significant differences were observed in terms of postoperative complications (p = 0.952), postoperative pain intensity at 24, 48, or 72 h (p = 0.375, p = 0.601, and p = 0.821, respectively), or postoperative supplementary analgesic use between the two groups (p = 0.881). In addition, the postoperative complication rate was 33.3% following laparoscopic approaches and 31.2% following open approaches in the PCIT group, with no significant difference (p = 1.000). CONCLUSION: In patients with AGC, gastrectomy with D2 or D2 + lymphadenectomy after PCIT had comparable short-term oncological outcomes to PCT.

Short-and long-term outcomes of laparoscopic versus open gastrectomy in patients with gastric cancer: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Laparoscopic gastrectomy (LG) for gastric cancer has rapidly developed and become more popular in recent decades. Additional high-quality randomized controlled trial (RCT) studies comparing LG versus open gastrectomy (OG) for gastric cancer (GC) have been published in recent years. An updated systematic review is warranted. The aim of our meta-analysis was to comprehensively evaluate the short- and long-term outcomes of LG versus OG for GC. MATERIALS AND METHODS: The PubMed, Embase, Web of Science, and Cochrane Center Register of Controlled Trials databases were comprehensively searched to identify RCTs comparing LG versus OG for GC published between January 1994 and December 7, 2021. This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Cochrane Collaboration and the Quality of Reporting of Meta-analyses (QUORUM) guidelines. All RCTs comparing the short- and long-term outcomes of LG with those of OG were included. A random effects model was adopted with significant heterogeneity (I2 > 50%), while a fixed effects model was employed in all other cases (I2 ≤ 50%). RESULTS: A total of 26 RCTs with 8301 patients were included in this meta-analysis. The results indicated that the intraoperative complication rate was comparable between the LG group and the OG group (OR=1.14, 95% CI [0.76, 1.70], I2=0%, p=0.53). The LG group had fewer postoperative complications than the OG group (OR=0.65, 95% CI [0.57, 0.74], I2=26%, p<0.00001). However, the severe postoperative complication rate and perioperative mortality were comparable between the two groups (OR=0.83, 95% CI [0.67, 1.04], I2=10%, p=0.10; OR=1.11, 95% CI [0.59, 2.09], I2=0%, p=0.74, respectively). The number of lymph nodes retrieved by the LG group was less than that of the OG group (MD=-1.51, 95% CI [-2.29, -0.74], I2=0%, p<0.0001). The proximal resection margin distance in the LG group was shorter than that in the OG group (MD=-0.34, 95% CI [-0.57, -0.12], I2=23%, p=0.003), but the distal resection margin distance in the two groups was comparable (MD=-0.21, 95% CI [-0.47, 0.04], I2=0%, p=0.10). The time to first ambulation was shorter in the LG group than in the OG group (MD=-0.14, 95% CI [-.26, -0.01], I2=40%, p=0.03). The time to first flatus was also shorter in the LG group than in the OG group (MD=-0.15, 95% CI [-0.23, -0.07], I2=4%, p=0.0001). However, the first time on a liquid diet was comparable between the two groups (MD=-0.30, 95% CI [-0.64, 0.04], I2=88%, p=0.09). Furthermore, the postoperative length of stay was shorter in the LG group than in the OG group (MD=-1.26, 95% CI [-1.99, -0.53], I2=90%, p=0.0007). The 5-year overall survival (OS) was comparable between the two groups (HR=0.97, 95% CI [0.80, 1.17], I2=0%, p=0.73), and the 5-year disease-free survival (DFS) was also similar between the LG group and OG group (HR=1.08, 95% CI [0.77, 1.52], I2=0%, p=0.64). CONCLUSION: LG is a technically safe and feasible alternative to OG with the advantages of a fewer postoperative complication rate, faster recovery of gastrointestinal function, and greater cosmetic benefit for patients with GC. Meanwhile, LG has comparable long-term outcomes to OG for GC.

Laparoscopic vs. open lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction: An exploratory, observational, prospective, IDEAL stage 2b cohort study (CLASS-10 study).

Objective: This study aims to verify the feasibility and efficacy of laparoscopic lower mediastinal lymphadenectomy for Siewert type II/III adenocarcinoma of esophagogastric junction (AEG). Setting: An exploratory, observational, prospective, cohort study will be carried out under the Idea, Development, Exploration, Assessment and Long-term Follow-up (IDEAL) framework (stage 2b). Participants: The study will recruit 1,036 patients with cases of locally advanced AEG (Siewert type II/III, clinical stage cT2-4aN0-3M0), and 518 will be assigned to either the laparoscopy group or the open group. Interventions: Patients will receive lower mediastinal lymphadenectomy along with either total or proximal gastrectomy. Primary and secondary outcome measures: The primary endpoint is the number of lower mediastinal lymph nodes retrieved, and the secondary endpoints are the surgical safety and prognosis, including intraoperative and postoperative lower-mediastinal-lymphadenectomy-related morbidity and mortality, rate of rehospitalization, R0 resection rate, 3-year local recurrence rate, and 3-year overall survival. Conclusions: The study will provide data for the guidance and development of surgical treatment strategies for AEG. Trial registration number: The study has been registered in ClinicalTrials.gov (No. NCT04443478).

The significance of time interval between perioperative SOX/XELOX chemotherapy and clinical decision model in gastric cancer.

Introduction: To investigate the influences of time interval between multimodality therapies on survival for locally advanced gastric cancer (LAGC) patients, 627 patients were included in a retrospective study, and 350 who received neoadjuvant chemotherapy (NACT) based on SOX (S-1 plus Oxaliplatin)/XELOX (Capecitabine plus Oxaliplatin) treatment, radical surgery, and adjuvant chemotherapy (AC) from 2005.01 to 2018.06 were eligible for analyses. Methods: Three factors were used to assess influences, including time interval from NACT accomplishment to AC initiation (PECTI), time to surgery after NACT accomplishment (TTS), and time to adjuvant chemotherapy after surgery (TAC). Results: Concerning PECTIs, 99 (28.29%) experienced it within 9 weeks, 188 (53.71%) within 9-13 weeks, 63 (18.00%) over 13 weeks. Patients' 5-year overall survival (OS) significantly decreased as trichotomous PECTI increased (78.6% vs 66.7% vs 55.7%, P = .02). Analogously, there was a significant decrease for dichotomous TTS (within vs over 5 weeks) in OS (P = .03) and progression free survival (PFS) (P = .01) but not for dichotomous TAC (within vs over 6 weeks) in OS and PFS (P = .40). Through multivariate Cox analyses, patients with PECTI over 13 weeks had significantly worse OS (P = .03) and PFS (P = .02). Furthermore, extended TTS had significantly worse OS and PFS but insignificantly worse OS and PFS than extended TAC. Therefore, gastric patients receiving perioperative SOX/XELOX chemotherapy and surgery with extended PECTI over 9 weeks or TTS over 5 weeks would have a negative correlation with PFS and OS, and worse when PECTI over 13 weeks. Nomograms (including PECTI, ypT, ypN, Area Under Curve (AUC) = 0.81) could predict patient survival probability and guide intervention with net benefit. Discussion: In control of PECTI, TTS could be extended appropriately, and shortened TAC might make a remedy, and delayed TAC might be allowed when TTS was shortened.

Duration of Perioperative Chemotherapy in Locally Advanced Gastric Cancer: A "Less Is More" Question When ypN0 Is Achieved.

BACKGROUNDS: Perioperative chemotherapy (PEC) and neoadjuvant chemotherapy (NAC) have become a vital part of locally advanced gastric cancer (LAGC) treatment, but the optimal duration of PEC has not been studied. The aim of this study was to demonstrate the possibility of duration reduction in PEC in the adjuvant chemotherapy (AC) phase for ypN0 patients. METHODS: We included LAGC patients who achieved ypN0 after NAC in our institution from 2005 to 2018. The risk/benefit of AC and other covariates were majorly measured by overall survival (OS) and progression-free survival (PFS). We developed a survival-tree-based model to determine the optimal PEC duration for ypN0 patients in different classes. RESULTS: A total of 267 R0 resection patients were included. There were 55 patients who did not receive AC. The 5-year OS was 74.34% in the non-AC group and 83.64% in the AC group with a significant difference (p = 0.012). Multivariate Cox regression revealed that both AC (AC vs. non-AC: HR, 0.49; 95%CI, 0.27-0.88; p = 0.018) and ypT stages (ypT3-4 vs. ypT0-2: HR, 2.00; 95%CI, 1.11-3.59; p = 0.021) were significant protective/risk factors on patients OS and PFS. A decision tree model for OS indicated an optimal four to six cycles of PEC, which was recommended for ypT0-2N0 patients, while a minimum of five PEC cycles was recommended for ypT3-4N0 patients. CONCLUSION: AC treatment is still necessary for ypN0. The duration reduction could be applied for the ypT0-2N0 stage patients but may not be suitable for higher ypT stages and beyond. A multicenter-based study is required.

Combination of tumor markers predicts progression and pathological response in patients with locally advanced gastric cancer after neoadjuvant chemotherapy treatment.

BACKGROUND: The prognostic values of preoperative tumor markers (TMs) remain elusive in patients with locally advanced gastric cancer (LAGC) after neoadjuvant chemotherapy treatment (NACT). This study aimed to assess and establish a novel scoring system incorporating carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 72-4 (CA72-4) to enhance prognostic accuracy for progression-free survival (PFS) and pathological response (pCR). METHODS: Patients' data were retrospectively analyzed from December 2006 to December 2017 in our center. The cutoff value of TMs was determined using the time-dependent receiver operating test characteristics method. These three TMs were allocated 1 point each for the post neoadjuvant chemotherapy combination of tumor markers (post-NACT CTM) scores. The training group comprised 533 patients, responsible for full analysis, and the validation group comprised 137 patients based on the selection protocol. RESULTS: Of 533 enrolled patients, 138, 233, 117, and 45 patients scored 0, 1, 2, 3 respectively. The 3-year PFS rate Multivariate analysis revealed that post-NACT CTM score was an independent predictor of PFS (0 vs. 1, HR: 1.34, 95% CI: 0.92-1.96, P = 0.128; 0 vs. 2, HR: 2.03, 95% CI: 1.35-3.05, P = 0.001; 0 vs. 3, HR: 2.98, 95% CI: 1.83-4.86, P < 0.001). The time-dependent area under curve (AUC) revealed a consistent highest level for post-NACT CTM than other three single TMs. Lower post-NACT CTM score significantly correlated with higher pCR rate based on multivariate logistic regression (2/3 vs. 1, OR: 2.77, 95% CI: 0.90-8.53, P = 0.077; 2/3 vs. 0, OR: 4.33, 95% CI: 1.38-13.61, P = 0.012). A nomogram was formed with both internal and external validation. CONCLUSIONS: The post-NACT CTM score system served as a strong independent predictor for PFS and pCR in LAGC patients who received NACT. Further population-based studies are required to confirm our results.

Treatment Switch in Poor Responders with Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy.

BACKGROUND: Among locally advanced gastric cancer (LAGC) patients, poor response to initial neoadjuvant chemotherapy (NAC) is associated with unfavorable outcomes; however, changing the postoperative therapy regimen in this group of patients is unclear. We compared the poor responders who continued the original protocols with that of patients who switched treatment after NAC plus D2 gastrectomy. METHODS: Our study included LAGC patients who achieved tumor regression grade 3 according to the American Joint Committee on Cancer/College of American Pathologists system, after NAC, between December 2006 and December 2017 at our institution. Outcomes were overall survival (OS), progression-free survival (PFS), and adverse events during postoperative treatment. The propensity score matching method was used to match patients. RESULTS: Overall, 160 patients were enrolled in the final analysis set, including 21 switched cases and 139 non-switched cases. A 1:2 matched cohort (21 switching vs. 42 non-switching) was generated to eliminate all confounding factors. No statistical differences were observed in OS and PFS, either in the whole patients (OS: log-rank p = 0.804; PFS: log-rank p = 0.943) or in the matched cohort (OS: log-rank p = 0.907; PFS: log-rank p = 0.670) between the two groups. Patients with changed regimens had a significantly higher rate of peripheral neurotoxicity (p = 0.045). Contrarily, a lower rate of overall adverse events was observed in the non-switching group with marginal significance (p = 0.069). CONCLUSION: Adjusting to a non-cross-resistant regimen only by post-NAC pathological evaluation may not be sufficient for designing an effective treatment route for LAGC poor responders. Treatment change required a more scrutinized clinical track, which involved a multifaceted assessment.

Oxaliplatin plus S-1 or capecitabine as neoadjuvant or adjuvant chemotherapy for locally advanced gastric cancer with D2 lymphadenectomy: 5-year follow-up results of a phase II-III randomized trial.

OBJECTIVE: To compare the effect of neoadjuvant chemotherapy (NACT) with adjuvant chemotherapy (ACT) using oxaliplatin plus S-1 (SOX) or capecitabine (CapeOX) on gastric cancer patients with D2 lymphadenectomy. METHODS: This was a two-by-two factorial randomized phase II-III trial, and registered on ISRCTN registry (No. ISRCTN12206108). Locally advanced gastric cancer patients were randomized to neoadjuvant SOX, neoadjuvant CapeOX, adjuvant SOX, or adjuvant CapeOX arms. Primary analysis was performed on an intention-to-treat (ITT) basis using overall survival (OS) as primary endpoint. RESULTS: This trial started in September 2011 and closed in December 2012 with 100 patients enrolled. Treatment completion rate was 56%, 52%, 38% and 30% in the four arms, respectively. NACT group had fewer dropouts due to unacceptable toxicity (P=0.042). Surgical complication rate did not differ by the four groups (P=0.986). No survival significant difference was found comparing NACT with ACT (P=0.664; 5-year-OS: 70% vs. 74% respectively), nor between the SOX and CapeOX groups (P=0.252; 5-year-OS: 78% vs. 66% respectively). Subgroup analysis showed SOX significantly improved survival in patients with diffuse type (P=0.048). CONCLUSIONS: No significant survival difference was found between NACT and ACT. SOX and CapeOX had good safety and efficacy as neoadjuvant regimens. Diffuse type patients may survive longer due to SOX.

Laparoscopic versus open gastrectomy for elderly local advanced gastric cancer patients: study protocol of a phase II randomized controlled trial.

BACKGROUND: Gastric cancer is one of the most common malignant tumors worldwide. With the rapid aging of global population, the number of elderly patients with local advanced gastric cancer is increasing. Surgery is the essential treatment for local advanced gastric cancer. However, elderly patients are at high risk of postoperative complications due to reduced functional reserve and increased comorbidities. Laparoscopic gastrectomy may be a promising surgery approach for elderly patients but its benefits remain controversial. We therefore proposed this randomized trial to evaluate the safety and efficacy of laparoscopic versus open gastrectomy for local advanced gastric cancer in patients aged 70 and above. METHODS: The current study has a randomized, parallel controlled, single-center, open-label, superiority design with two arms. A sample of 180 local advanced gastric cancer patients aged 70 and above will be recruited in Peking University Cancer Hospital and Institute. Participants will be randomized to either receive open or laparoscopic gastrectomy. The primary outcome is surgical safety, including complication rate, reoperation rate, readmission rate, and mortality rate within 30 days after surgery. The secondary endpoints include postoperative rehabilitation status, one-year postoperative life quality, three-year overall and disease-free survival. Assessments will take place at baseline (before random assignment), at 30 days, one-year, and three-year after the surgery. The study has been approved by an ethical review board. DISCUSSION: We hypothesized that laparoscopic gastrectomy is superior to open gastrectomy in terms of perioperative safety for local advanced gastric cancer patients aged 70 and above. If this hypothesis is statistically proved, the rational introduction of minimally invasive surgery technique in traditional gastrectomy can help improve the surgical safety for elderly patients, reduce patient financial burden, shorten hospital stay, and improve hospital beds turnover rate. Our research data will also provide high quality clinical evidence and data support for the conduction of multicenter phase III clinical trials. TRIAL REGISTRATION: The study has been prospectively registered in ClinicalTrial.gov ( NCT03564834 ).

Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy for advanced gastric cancer: study protocol for a randomised phase II trial.

INTRODUCTION: Current guidelines recommend open gastrectomy with D2 lymph node dissection and adjuvant chemotherapy as the standard treatment for advanced gastric cancer. However, the prognosis is not satisfactory. Perioperative chemotherapy has been proposed to improve survival. Although still in debate, the efficacy of laparoscopic distal gastrectomy (LDG) in patients with advanced gastric cancer has been demonstrated in a few trials. Therefore, LDG after neoadjuvant chemotherapy can be a candidate for future standard treatment on advanced distal gastric cancer. We propose a randomised phase II trial to compare LDG and open distal gastrectomy (ODG) after neoadjuvant chemotherapy for advanced gastric cancer. METHODS AND ANALYSIS: To test the efficacy and safety, a randomised, open-label, single-centre, phase II trial was designed to evaluate the non-inferiority of LDG compared with ODG after neoadjuvant chemotherapy, with 3-year recurrence-free survival as the primary endpoint. The chosen critical value of a non-inferiority margin was an increase of <8%. The study started in 2015 and enrolled 96 patients according to a prior sample size calculation. Intention-to-treat and per-protocol approach will be used for efficacy analysis, and as-treated analysis will be applied for safety analysis. The survival curves will be constructed as time-to-event plots using the Kaplan-Meier method and compared using log-rank tests and Cox proportional hazards model. All statistical analyses will be conducted in standard statistical software with a significance level of 0.05. ETHICS AND DISSEMINATION: This study was approved by the Peking University Cancer Hospital Ethics Committee. The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02404753; Pre-results.

ypTNM staging after neoadjuvant chemotherapy in the Chinese gastric cancer population: an evaluation on the prognostic value of the AJCC eighth edition cancer staging system.

BACKGROUND: This study aims to evaluate the new ypTNM staging system in Chinese gastric cancer patients. METHODS: We conducted retrospective survival and regression analyses using a database of gastric cancer patients who underwent neoadjuvant chemotherapy at the Peking University Cancer Hospital and Institute from January 2007 to January 2015. RESULTS: A total of 473 patients were included in the study with 28 pathological complete response (pCR) cases, 3 ypT0N1 cases, 65 stage I cases, 126 stage II cases, and 251 stage III cases. The pCR cases had similar survival to stage I patients (p > 0.05). The 3-year disease-free survival (DFS) and 5-year overall survival (OS) rates of stage I, II and III patients were significantly different (3-year DFS: 89.0, 75.5, and 39.6%, p < 0.001; 5-year OS: 89.6, 65.5, and 36.5%, p = 0.001). Both ypT and ypN are independent predictors of patient survival, while further log-rank tests showed that the ypN stage is of better prognostic value than ypT. Subgrouping analysis revealed that stage III patients of ypT4b and ypN3 had worse survival compared to the rest of stage III cases (p < 0.001). The c-index values of the ypTNM stage and modified ypTNM stage (stage III divided into IIIa and IIIb) were 0.657 and 0.708, respectively (p < 0.001). CONCLUSIONS: Our data showed significant differences in survival among gastric cancer patients at different ypTNM stages, indicating its prognostic value in the Chinese population. Further detailed analyses may facilitate the subgrouping of each stage to allow for a more accurate evaluation of disease prognosis in gastric cancer patients.

[Comparison of the safety and the costs between laparoscopic assisted or totally laparoscopic uncut Roux-en-Y and BillrothII(+Braun reconstruction--a single center prospective cohort study].

OBJECTIVE: To compare the short-term safety and costs between laparoscopic assisted or totally laparoscopic uncut Roux-en-Y and Billroth II((BII() + Braun reconstruction after radical gastrectomy of distal gastric cancer. METHODS: Clinical data from our prospective database of radical gastrectomy were systematically analyzed. The patients who underwent laparoscopic gastrectomy with uncut Roux-en-Y or BII(+ Braun reconstruction between March 1st, 2015 and June 30th, 2017 were screened out for further analysis. Both the reconstructions were completed by linear staplers. Uncut Roux-en-Y reconstruction was performed with a 45 mm no-knife linear stapler (ATS45NK) on the afferent loop below the gastrojejunostomy. Continuous variables were compared using independent samples t test or Mann-Whitney U. The frequencies of categorical variables were compared using Chi-squared or Fisher exact test. RESULTS: Eighty-one patients were in uncut Roux-en-Y group and 58 patients were in BII(+Braun group. There were no significant differences between uncut Roux-en-Y group and BII(+Braun group in median age (56.0 years vs. 56.5 years, P=0.757), gender (male/female, 52/29 vs. 46/12, P=0.054), history of abdominal surgery (yes/no, 10/71 vs. 4/54, P=0.293), neoadjuvant chemotherapy (yes/no, 21/60 vs. 11/47, P=0.336), BMI (thin/normal/overweight/obesity, 2/49/26/3 vs. 3/39/14/2, P=0.591), NRS 2002 score (1/2/3/4, 58/15/5/3 vs. 47/5/3/3, P=0.403), pathological stage (0/I(/II(/III(, 3/41/20/17 vs. 1/28/13/16, P=0.755), median tumor diameter in long axis (2.5 cm vs. 3.0 cm, P=0.278), median tumor diameter in short axis (2.0 cm vs. 2.0 cm, P=0.126) and some other clinical and pathological characteristics. There were no significant differences between uncut Roux-en-Y group and BII(+Braun group in morbidity of postoperative complication more severe than grade I([12.3% (10/81) vs. 17.2% (10/58), P=0.417], morbidity of anastomotic complication [1.2%(1/81) vs. 0, P=1.000] or hospitalization costs [(94000±14000) yuan vs.(95000±16000) yuan, P=0.895]. The median first time to liquid diet (57.1 hours vs. 70.8 hours, P=0.017) and median postoperative hospital stay (9 days vs. 11 days, P=0.003) of the patients in uncut Roux-en-Y group were shorter than those in BII(+Braun group. CONCLUSION: Laparoscopic assisted or totally laparoscopic uncut Roux-en-Y reconstruction after radical gastrectomy of distal gastric cancer is safe and feasible with better recovery than BII(+Braun reconstruction.

[Current status of diagnosis and treatment of early gastric cancer in China--Data from China Gastrointestinal Cancer Surgery Union].

OBJECTIVE: To investigate the current status of diagnosis and treatment of early gastric cancer in China, based on the nationwide survey by China Gastrointestinal Cancer Surgery Union. METHODS: The union sent questionnaires on basic diagnosis and treatment data of gastric and colorectal cancer to all the centers of the union. Different centers collected and summarized their data by year and sent back the questionnaires to the e-mail of theunion(gi_union@foxmail.com) for summary. RESULTS: From 2014 to 2016, the union collected 285 questionnaires from 85 centers all over China. In these 3 years, a total of 88 340 cases of gastric cancer were summarized and there were 17 187 cases of early gastric cancer (part of the data was not available in some centers). The proportion of early gastric cancer varied from 19.5%(5711/29290) in 2014 to 19.0%(6081/32050) in 2015 and 20.0%(5395/27000) in 2016. Significant difference was found among them (χ2=9.553, P=0.008). Significant differences existed not only in the proportion of early gastric cancer between the south (20.9%, 7618/ 36518) and the north (18.5%, 9569/51822) of China (χ2=78.468, P=0.000), but also between the general (20.4%, 11991/58672) and the specialized (17.5%, 5196/29668) hospitals(χ2=107.473, P=0.000). Ultrasonic endoscope was used as routine practice in 10(17.5%, 10/57) general hospitals and 9(56.2%,9/16) specialized hospitals, and significant difference was found between them (χ2=9.721, P=0.002). A total of 4555 early gastric cancer patients received endoscopic therapy. The proportion of patients receiving endoscopic therapy was significantly different between the hospitals in the first-tier cities (36.0%, 2243/6233) and the other cities (21.1%, 2312/10954) (χ2=451.526, P=0.000), and between the hospitals with more than 800 gastric cancer patients per year (28.9%, 3434/11884) and those with less than 800 gastric cancer patients (21.1%, 1121/5303)(χ2=113.270, P=0.000). 37.1%(5270/14186) of early gastric cancer patients received laparoscopic surgery. The proportion of patients receiving laparoscopic surgery was 39.4%(3807/9651) in general hospitals and 32.3%(1463/4535) in specialized hospitals, whose difference was significant (χ2=68.244, P=0.000). The proportion of patients receiving laparoscopic surgery was 29.3%(1269/4328) in the first-tier cities and 40.6%(4001/9858) in the other cities, whose difference was significant as well(χ2=163.480, P=0.000). The proportion of patients receiving laparoscopic surgery was significantly different between the hospitals with more than 800 gastric cancer patients per year(34.5%, 3425/9929) and those with less than 800 gastric cancer patients (43.3%, 1845/4257) (χ2=100.057, P=0.000), and between the hospitals in the south (42.4%, 2552/6016) and those in the north (33.3%, 2718/8170) of China (χ2=124.296, P=0.000). 48.5%(6975) of early gastric cancer patients staged pT1a and 51.5%(7402) staged pT1b. Lymph node metastasis was found in 12.7%(1825/14377) of early gastric cancer. The lymph node metastasis rate of pT1a and pT1b was 5.7%(399/6975) and 19.3%(1426/7402), respectively. The lymph node metastasis rate of early gastric cancer varied from 12.7%(510/4017) in 2014 to 12.2%(668/5494) in 2015 and 13.3%(647/4866) in 2016. CONCLUSION: The data report of China Gastrointestinal Cancer Surgery Union partly reflects the epidemiologic characteristics, current status of diagnosis and treatment of early gastric in China.