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PURPOSE: Laparoscopic distal gastrectomy (LDG) is a difficult procedure for early career surgeons. Artificial intelligence (AI)-based surgical step recognition is crucial for establishing context-aware computer-aided surgery systems. In this study, we aimed to develop an automatic recognition model for LDG using AI and evaluate its performance. METHODS: Patients who underwent LDG at our institution in 2019 were included in this study. Surgical video data were classified into the following nine steps: (1) Port insertion; (2) Lymphadenectomy on the left side of the greater curvature; (3) Lymphadenectomy on the right side of the greater curvature; (4) Division of the duodenum; (5) Lymphadenectomy of the suprapancreatic area; (6) Lymphadenectomy on the lesser curvature; (7) Division of the stomach; (8) Reconstruction; and (9) From reconstruction to completion of surgery. Two gastric surgeons manually assigned all annotation labels. Convolutional neural network (CNN)-based image classification was further employed to identify surgical steps. RESULTS: The dataset comprised 40 LDG videos. Over 1,000,000 frames with annotated labels of the LDG steps were used to train the deep-learning model, with 30 and 10 surgical videos for training and validation, respectively. The classification accuracies of the developed models were precision, 0.88; recall, 0.87; F1 score, 0.88; and overall accuracy, 0.89. The inference speed of the proposed model was 32 ps. CONCLUSION: The developed CNN model automatically recognized the LDG surgical process with relatively high accuracy. Adding more data to this model could provide a fundamental technology that could be used in the development of future surgical instruments.
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Inteligencia Artificial , Gastrectomía , Laparoscopía , Prueba de Estudio Conceptual , Neoplasias Gástricas , Humanos , Gastrectomía/métodos , Laparoscopía/métodos , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/patología , Femenino , Masculino , Persona de Mediana Edad , Cirugía Asistida por Computador/métodos , Anciano , Escisión del Ganglio LinfáticoRESUMEN
BACKGROUND: Chemoradiotherapy (CRT) modulates the tumor immune microenvironment of multiple cancer types, including esophageal cancer, which potentially induces both immunogenicity and immunosuppression by upregulating the presentation of tumor-specific antigens and immune checkpoint molecules in tumors, respectively. The prognostic effects of immune modification by CRT in esophageal squamous cell carcinoma (ESCC) remain controversial because of the lack of detailed immunological analyses using paired clinical specimens before and after CRT. We aimed to clarify the immunological changes in the tumor microenvironment caused by CRT and elucidate the predictive importance of clinical response and prognosis and the rationale for the necessity of subsequent programmed cell death protein 1 (PD-1) inhibitor treatment. METHODS: In this study, we performed a comprehensive immunological analysis of paired biopsy specimens using multiplex immunohistochemistry before and after CRT in patients with unresectable locally advanced ESCC. RESULTS: CRT significantly increased the intra-tumoral infiltration and PD-1 expression of CD8+ T cells and conventional CD4+ T cells but decreased those of regulatory T cells and the accumulation of tumor-associated macrophages. Multivariate analysis of tumor-infiltrating T-cell phenotypes revealed that the density of PD-1+CD8+ T cells in the tumor after CRT could predict a confirmed complete response and favorable survival. CONCLUSIONS: This study showed that CRT improved the immunological characteristics of unresectable locally advanced ESCC and identified the density of PD-1+CD8+ T cells as a predictive factor for prognosis. This finding supports the rationale for the necessity of subsequent PD-1 inhibitor treatment.
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Linfocitos T CD8-positivos , Quimioradioterapia , Neoplasias Esofágicas , Carcinoma de Células Escamosas de Esófago , Linfocitos Infiltrantes de Tumor , Microambiente Tumoral , Humanos , Microambiente Tumoral/inmunología , Neoplasias Esofágicas/terapia , Neoplasias Esofágicas/inmunología , Neoplasias Esofágicas/patología , Quimioradioterapia/métodos , Masculino , Femenino , Carcinoma de Células Escamosas de Esófago/terapia , Carcinoma de Células Escamosas de Esófago/inmunología , Carcinoma de Células Escamosas de Esófago/patología , Anciano , Persona de Mediana Edad , Linfocitos T CD8-positivos/inmunología , Linfocitos Infiltrantes de Tumor/inmunología , Receptor de Muerte Celular Programada 1/antagonistas & inhibidores , Pronóstico , Linfocitos T CD4-Positivos/inmunología , Inhibidores de Puntos de Control Inmunológico/uso terapéutico , Anciano de 80 o más Años , Macrófagos Asociados a Tumores/inmunologíaRESUMEN
Background: There are two methods of Roux-en-Y (RY) reconstruction after gastrectomy: the antecolic route (ACR) and retrocolic route (RCR). There is no evidence to support that the ACR achieves comparable long-term survival. Methods: This was a multi-center historical cohort study. Patients diagnosed with clinical T3/4a and any N stage who underwent open gastrectomy and R0 resection for gastric adenocarcinoma between January 2006 and December 2012 were enrolled. The primary outcome was the hazard ratio of ACR for overall survival, with adjustment for confounding factors by propensity score matching, and a Cox proportional hazards model. Results: A total of 1758 eligible patients were identified from the database. After matching, 410 patients in the ACR and RCR groups were included in the final analysis. The adjusted hazard ratio (95% CI) for ACR was 1.148 (0.870-1.492). The five-year survival rates in the ACR and RCR groups were 74.3% (69.5-78.4) and 77.3% (72.3-81.2), respectively. The short-term surgical outcomes of the two groups did not differ to a statistically significant extent. Conclusion: The route used to lift the jejunum in RY reconstruction did not affect the incidence of long-term survival or postoperative complications. The ACR and RCR are both acceptable options for RY reconstruction during gastric cancer surgery.
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BACKGROUND: Laparoscopic surgery for early gastric cancer is regarded as a standard of care because of robust evidences obtained by several phase-III trials. Furthermore, the efficacy of laparoscopic radical surgery for advanced gastric cancer has been also reported. Meanwhile, the feasibility of laparoscopic surgery for Bormann type 4 gastric cancer, special type with unfavorable prognosis, remains unclear since excluded from eligibility of these trials. METHODS: This study included 100 patients with type 4 gastric cancer who underwent laparoscopic/robot-assisted (minimally invasive surgery (MIS) group; n = 32) or open (Open group; n = 68) curative surgery between 2008 and 2021. After propensity score matching, 30 patients in each group were extracted for analysis. Clinical data, including surgical and midterm survival outcomes, were retrospectively compared between the two groups. RESULTS: Incidences of postoperative complication (≥ Clavien-Dindo grade III) were recorded in 23.3% in the MIS group and 13.3% in the Open group, but no statistical significance was demonstrated (P = 0.50). The 3-year overall survival rate in the MIS group was better than that in the Open group (80.2% vs. 53.5%, log-rank, P = 0.03). The trend of recurrence site was similar. Multivariate analysis showed that adjuvant chemotherapy was an independent favorable prognostic factor (hazard ratio, 0.33, 95% confidence interval 0.11-0.93) for overall survival. MIS was indicated as a favorable prognostic factor (hazard ratio, 0.39, 95% confidence interval 0.39-1.07), but without statistical difference. CONCLUSION: While multidisciplinary treatment is mainstay of treatment because of the poor prognosis of this disease, minimally invasive surgery may play an important role in treatment if appropriate patient selection is done. Further analyses with larger sample size are necessary to reach a final conclusion regarding oncological efficacy.
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Estudios de Factibilidad , Gastrectomía , Laparoscopía , Procedimientos Quirúrgicos Robotizados , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/patología , Neoplasias Gástricas/mortalidad , Masculino , Femenino , Laparoscopía/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Persona de Mediana Edad , Estudios Retrospectivos , Anciano , Gastrectomía/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Resultado del Tratamiento , Puntaje de Propensión , AdultoRESUMEN
The data presented here aim to show how to analyze crack propagation of a novel metallic matrix composite of Ti-6Al-4V reinforced with 1 wt.% nano-yttria-stabilized zirconia processed by laser powder bed fusion technology. The data was acquired via microstructural observations and electron backscatter diffraction (EBSD) analyses after the quasistatic tensile tests at room temperature. The overall crack path configuration based on the fracture surface observation by scanning electron microscopy (SEM) was first operated, presenting two main regions: (i) local inclined planes (hereafter denoted as "stair-like"), and (ii) region in accordance with the theoretical mode I fracture plane. Thereafter, a series of EBSD data set on a surface obtained after longitudinal cut off operation on one failed piece was conducted at three distinct positions: (i) in the stair-like configuration region, (ii) in the mode I fracture region, and (iii) in the region where the crack path made his transition between these two mechanisms. Since the EBSD data sets were not prone to any post-processing filtering operation, comparison of the observed mechanism with other Ti-6Al-4V alloy processed by additive manufacturing (AM) technology can be easily carried out.
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BACKGROUND: This randomized phase II study explored the superiority of trastuzumab plus S-1 plus cisplatin (SP) over SP alone as neoadjuvant chemotherapy (NAC) for HER2-positive resectable gastric cancer with extensive lymph node metastasis. METHODS: Eligible patients with HER2-positive gastric or esophagogastric junction cancer and extensive lymph node metastasis were randomized to receive three or four courses of preoperative chemotherapy with SP (arm A) or SP plus trastuzumab (arm B). Following gastrectomy, adjuvant chemotherapy with S-1 was administered for 1 year in both arms. The primary endpoint was overall survival, and the sample size was 130 patients in total. The trial is registered with the Japan Registry of Clinical Trials, jRCTs031180006. RESULTS: This report elucidates the early endpoints, including pathological findings and safety. The study was terminated early due to slow patient accruals. In total, 46 patients were allocated to arm A (n = 22) and arm B (n = 24). NAC was completed in 20 patients (91%) in arm A and 23 patients (96%) in arm B, with similar incidences of grade 3-4 hematological and non-hematological adverse events. Objective response rates were 50% in arm A and 84% in arm B (p = 0·065). %R0 resection rates were 91% and 92%, and pathological response rates (≥ grade 1b in Japanese classification) were 23% and 50% (p = 0·072) in resected patients, respectively. CONCLUSIONS: Trastuzumab can be safely added to platinum-containing doublet chemotherapy as NAC, and it has the potential to contribute to higher antitumor activity against locally advanced, HER2-positive gastric or esophagogastric junction cancer with extensive nodal metastasis.
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Adenocarcinoma , Neoplasias Esofágicas , Neoplasias Gástricas , Humanos , Trastuzumab/uso terapéutico , Neoplasias Gástricas/tratamiento farmacológico , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/patología , Metástasis Linfática/patología , Japón , Receptor ErbB-2 , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Unión Esofagogástrica/patología , Adenocarcinoma/tratamiento farmacológico , Adenocarcinoma/cirugía , Adenocarcinoma/patología , Oncología Médica , Terapia NeoadyuvanteRESUMEN
BACKGROUND: A previous report confirmed the safety of laparoscopy-assisted total and proximal gastrectomies (LATG and LAPG) (JCOG1401). This report demonstrates the 5-year relapse-free survival (RFS) and overall survival (OS) after long-term follow-up to confirm the efficacy of these surgical methods as key secondary endpoints for cStage I gastric cancer. METHODS: This study enrolled patients who had histologically proven gastric adenocarcinoma and were diagnosed with clinical T1N0, T1N(+), or T2N0 tumors according to the 14th edition of the Japanese Classification of Gastric Carcinoma (3rd English edition). RESULTS: Between April 2015 and February 2017, 246 patients were enrolled, although one patient was excluded because of misregistration. Meticulous follow-up was continued for > 5 years for each patient, and the data were analyzed in March 2022. The 5-year RFS was 90.0% (95% confidence interval [CI] 85.5-93.2%), and the 5-year OS was 91.2% (95% CI 86.9-94.2%) in all enrolled patients. Grade 3 or 4 late postoperative complications were detected in 12.7% of patients. CONCLUSIONS: This single-arm study showed that the long-term outcomes of LATG/LAPG for cStage I gastric cancer were acceptable, which is considered one of the standard treatments when performed by experienced surgeons. Trail registration UMIN000017155 ( http://www.umin.ac.jp/ctr/ ).
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Laparoscopía , Neoplasias Gástricas , Humanos , Estudios Retrospectivos , Neoplasias Gástricas/patología , Japón , Complicaciones Posoperatorias/cirugía , Laparoscopía/métodos , Gastrectomía/métodos , Oncología Médica , Resultado del TratamientoRESUMEN
BACKGROUND: Gastric surgery involves numerous surgical phases; however, its steps can be clearly defined. Deep learning-based surgical phase recognition can promote stylization of gastric surgery with applications in automatic surgical skill assessment. This study aimed to develop a deep learning-based surgical phase-recognition model using multicenter videos of laparoscopic distal gastrectomy, and examine the feasibility of automatic surgical skill assessment using the developed model. METHODS: Surgical videos from 20 hospitals were used. Laparoscopic distal gastrectomy was defined and annotated into nine phases and a deep learning-based image classification model was developed for phase recognition. We examined whether the developed model's output, including the number of frames in each phase and the adequacy of the surgical field development during the phase of supra-pancreatic lymphadenectomy, correlated with the manually assigned skill assessment score. RESULTS: The overall accuracy of phase recognition was 88.8%. Regarding surgical skill assessment based on the number of frames during the phases of lymphadenectomy of the left greater curvature and reconstruction, the number of frames in the high-score group were significantly less than those in the low-score group (829 vs. 1,152, P < 0.01; 1,208 vs. 1,586, P = 0.01, respectively). The output score of the adequacy of the surgical field development, which is the developed model's output, was significantly higher in the high-score group than that in the low-score group (0.975 vs. 0.970, P = 0.04). CONCLUSION: The developed model had high accuracy in phase-recognition tasks and has the potential for application in automatic surgical skill assessment systems.
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Laparoscopía , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirugía , Laparoscopía/métodos , Gastroenterostomía , Gastrectomía/métodosRESUMEN
OBJECTIVE: To gain insight in global practice of RAMIG and evaluated perioperative outcomes using an international registry. BACKGROUND: The techniques and perioperative outcomes of robot-assisted minimally invasive gastrectomy (RAMIG) for gastric cancer vary substantially in literature. METHODS: Prospectively registered RAMIG-cases for gastric cancer (≥10 per center) were extracted from 25 centers in Europe, Asia and South-America. Techniques for the resection, reconstruction, anastomosis and lymphadenectomy were analyzed, and related to perioperative surgical and oncological outcomes. Complications were uniformly defined by the Gastrectomy Complications Consensus Group. RESULTS: Between 2020-2023, 759 patients underwent total (n=272), distal (n=465) or proximal (n=22) gastrectomy (RAMIG). After total gastrectomy with Roux-en-Y-reconstruction, anastomotic leakage rates were 8% with hand-sewn (n=9/111) and 6% with linear stapled anastomoses (n=6/100). After distal gastrectomy with Roux-en-Y (67%) or Billroth-II-reconstruction (31%), anastomotic leakage rates were 3% with linear stapled (n=11/433) and 0% with hand-sewn anastomoses (n=0/26). Extent of lymphadenectomy consisted of D1+ (28%), D2 (59%) or D2+ (12%). Median nodal harvest yielded 31 nodes [IQR 21-47] after total and 34 nodes [IQR 24-47] after distal gastrectomy. R0-resection rates were 93% after total and 96% distal gastrectomy. Hospital stay was 9 days after total and distal gastrectomy, and was 3 days shorter without perianastomotic drains versus routine drain placement. Postoperative 30-day mortality was 1%. CONCLUSIONS: This large multicenter study provided a worldwide overview of current RAMIG-techniques with their respective perioperative outcomes. These outcomes demonstrated high surgical quality, set a quality standard for RAMIG and can be considered an international reference for surgical standardization.
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BACKGROUND: Laparoscopic gastrectomy (LG) is considered a standard treatment for clinical stage I gastric cancer. Nevertheless, LG has some drawbacks, such as motion restriction and difficulties in spatial perception. Robot-assisted gastrectomy (RG) overcomes these drawbacks by using articulated forceps, tremor-filtering capability, and high-resolution three-dimensional imaging, and it is expected to enable more precise and safer procedures than LG for gastric cancer. However, robust evidence based on a large-scale randomized study is lacking. METHODS: We are performing a randomized controlled phase III study to investigate the superiority of RG over LG for clinical T1-2N0-2 gastric cancer in terms of safety. In total, 1,040 patients are planned to be enrolled from 46 Japanese institutions over 5 years. The primary endpoint is the incidence of postoperative intra-abdominal infectious complications, including anastomotic leakage, pancreatic fistula, and intra-abdominal abscess of Clavien-Dindo (CD) grade ≥ II. The secondary endpoints are the incidence of all CD grade ≥ II and ≥ IIIA postoperative complications, the incidence of CD grade ≥ IIIA postoperative intra-abdominal infectious complications, relapse-free survival, overall survival, the proportion of RG completion, the proportion of LG completion, the proportion of conversion to open surgery, the proportion of operation-related death, and short-term surgical outcomes. The Japan Clinical Oncology Group Protocol Review Committee approved this study protocol in January 2020. Approval from the institutional review board was obtained before starting patient enrollment in each institution. Patient enrollment began in March 2020. We revised the protocol to expand the eligibility criteria to T1-4aN0-3 in July 2022 based on the results of randomized trials of LG demonstrating non-inferiority of LG to open surgery for survival outcomes in advanced gastric cancer. DISCUSSION: This is the first multicenter randomized controlled trial to confirm the superiority of RG over LG in terms of safety. This study will demonstrate whether RG is superior for gastric cancer. TRIAL REGISTRATION: The protocol of JCOG1907 was registered in the UMIN Clinical Trials Registry as UMIN000039825 ( http://www.umin.ac.jp/ctr/index.htm ). Date of Registration: March 16, 2020. Date of First Participant Enrollment: April 1, 2020.
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Laparoscopía , Procedimientos Quirúrgicos Robotizados , Robótica , Neoplasias Gástricas , Humanos , Resultado del Tratamiento , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Gastrectomía/efectos adversos , Gastrectomía/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Laparoscopía/efectos adversos , Laparoscopía/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto , Ensayos Clínicos Fase III como AsuntoRESUMEN
Significance: Determining the extent of gastric cancer (GC) is necessary for evaluating the gastrectomy margin for GC. Additionally, determining the extent of the GC that is not exposed to the mucosal surface remains difficult. However, near-infrared (NIR) can penetrate mucosal tissues highly efficiently. Aim: We investigated the ability of near-infrared hyperspectral imaging (NIR-HSI) to identify GC areas, including exposed and unexposed using surgical specimens, and explored the identifiable characteristics of the GC. Approach: Our study examined 10 patients with diagnosed GC who underwent surgery between 2020 and 2021. Specimen images were captured using NIR-HSI. For the specimens, the exposed area was defined as an area wherein the cancer was exposed on the surface, the unexposed area as an area wherein the cancer was present although the surface was covered by normal tissue, and the normal area as an area wherein the cancer was absent. We estimated the GC (including the exposed and unexposed areas) and normal areas using a support vector machine, which is a machine-learning method for classification. The prediction accuracy of the GC region in every area and normal region was evaluated. Additionally, the tumor thicknesses of the GC were pathologically measured, and their differences in identifiable and unidentifiable areas were compared using NIR-HSI. Results: The average prediction accuracy of the GC regions combined with both areas was 77.2%; with exposed and unexposed areas was 79.7% and 68.5%, respectively; and with normal regions was 79.7%. Additionally, the areas identified as cancerous had a tumor thickness of >2 mm. Conclusions: NIR-HSI identified the GC regions with high rates. As a feature, the exposed and unexposed areas with tumor thicknesses of >2 mm were identified using NIR-HSI.
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Neoplasias Gástricas , Humanos , Neoplasias Gástricas/diagnóstico por imagen , Neoplasias Gástricas/cirugía , Imágenes Hiperespectrales , Diagnóstico por Imagen , Aprendizaje AutomáticoRESUMEN
Oligometastases are generally defined as a small number of metastases(2-3 or less)in 1 or 2 organs. Oligometastases are rare in gastric cancer because they are often associated with peritoneal dissemination, but gastric cancer patients experience a relatively high incidence of para-aortic lymph node and liver metastases in particular. The Sixth Edition of the Japanese Gastric Cancer Treatment Guidelines weakly recommends surgical resection after medical therapy for a small number of para-aortic lymph node metastases confined to No. 16a2/b1 and a single liver metastasis in the absence of other non-curative resection factors. In Japan, the common treatment strategy is surgical resection after drug therapy, often with the addition of adjuvant chemotherapy after surgery as well. Preoperative drug therapy is generally administered for 3-4 months. Surgical resection has been shown to be relatively safe in experienced centers. Prospective clinical trials are underway in Japan and overseas to establish a higher level of evidence.
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Neoplasias Hepáticas , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/tratamiento farmacológico , Neoplasias Gástricas/cirugía , Estudios Prospectivos , Quimioterapia Adyuvante , JapónRESUMEN
Artificial intelligence (AI) has made significant progress in recent years, and many medical fields are attempting to introduce AI technology into clinical practice. Currently, much research is being conducted to evaluate that AI can be incorporated into surgical procedures to make them safer and more efficient, subsequently to obtain better outcomes for patients. In this paper, we review basic AI research regarding surgery and discuss the potential for implementing AI technology in gastric cancer surgery. At present, research and development is focused on AI technologies that assist the surgeon's understandings and judgment during surgery, such as anatomical navigation. AI systems are also being developed to recognize in which the surgical phase is ongoing. Such a surgical phase recognition systems is considered for effective storage of surgical videos and education, in the future, for use in systems to objectively evaluate the skill of surgeons. At this time, it is not considered practical to let AI make intraoperative decisions or move forceps automatically from an ethical standpoint, too. At present, AI research on surgery has various limitations, and it is desirable to develop practical systems that will truly benefit clinical practice in the future.
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PURPOSE: Limited evidence exists regarding outcomes associated with different correction rates of severe hyponatremia. MATERIALS AND METHODS: This retrospective cohort analysis employed a multi-center ICU database to identify patients with sodium ≤120 mEq/L during ICU admission. We determined correction rates over the first 24 h and categorized them as rapid (> 8 mEq/L/day) or slow (≤ 8 mEq/L/day). The primary outcome was in-hospital mortality. Secondary outcomes included hospital-free days, ICU-free days, and neurological complications. We used inverse probability weighting for confounder adjustment. RESULTS: Our cohort included 1024 patients; 451 rapid and 573 slow correctors. Rapid correction was associated with lower in-hospital mortality (absolute difference: -4.37%; 95% CI, -8.47 to -0.26%), longer hospital-free days (1.80 days; 95% CI, 0.82 to 2.79 days), and longer ICU-free days (1.16 days; 95% CI, 0.15 to 2.17 days). There was no significant difference in neurological complications (2.31%; 95% CI, -0.77 to 5.40%). CONCLUSION: Rapid correction (>8 mEq/L/day) of severe hyponatremia within the first 24 h was associated with lower in-hospital mortality and longer ICU and hospital-free days without an increase in neurological complication. Despite major limitations, including the inability to identify the chronicity of hyponatremia, the results have important implications and warrant prospective studies.
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Hiponatremia , Humanos , Hiponatremia/etiología , Estudios Retrospectivos , Estudios Prospectivos , Sodio , Unidades de Cuidados IntensivosRESUMEN
PURPOSE: A high body mass index (BMI) generally increases the risk of postoperative complications because of the intraperitoneal adipose tissue. Robotic gastrectomy (RG) decreases the surgical difficulty of conventional laparoscopic gastrectomy (LG) for these patients. We conducted the present study to identify the advantages of RG over LG for overweight patients. METHODS: We reviewed clinical data on patients who underwent either LG or RG at the National Cancer Center Hospital East between January, 2014 and May, 2022. RESULTS: The 1298 patients eligible patients were divided into a non-overweight cohort (n = 996) (LG, n = 818; RG, n = 178) and an overweight cohort (n = 302) (LG, n = 250; RG, n = 52) according to a BMI cut-off of 25 kg/m2. In the overweight cohort, the RG group had a lower incidence of grade ≥ III postoperative complications (0.0 vs. 8.8%, p = 0.01) and grade ≥ II postoperative complications (11.5 vs. 22.0%, p = 0.12) than the LG group. Multivariate analysis identified that RG was significantly associated with a lower incidence of grade ≥ II postoperative complications in the overweight cohort (odds ratio, 0.33; 95% confidence interval, 0.12-0.87; p = 0.02). CONCLUSIONS: RG may reduce the risk of postoperative complications, compared with conventional LG, in overweight patients.
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Laparoscopía , Procedimientos Quirúrgicos Robotizados , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/complicaciones , Sobrepeso/complicaciones , Resultado del Tratamiento , Gastrectomía/efectos adversos , Laparoscopía/efectos adversos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/etiología , Estudios RetrospectivosRESUMEN
Importance: Evidence of implementation of laparoscopic gastrectomy for locally advanced gastric cancer is currently insufficient, as the primary end point in previous prospective studies was evaluated at a median follow-up time of 3 years. More robust evidence is necessary to verify noninferiority of laparoscopic gastrectomy. Objective: To compare 5-year survival outcomes between laparoscopy-assisted distal gastrectomy (LADG) and open distal gastrectomy (ODG) with D2 lymph node dissection for locally advanced gastric cancer. Design, Setting, and Participants: This was a multicenter, open-label, noninferiority, prospective randomized clinical trial. Between November 26, 2009, and July 29, 2016, eligible patients with histologically proven gastric carcinoma from 37 institutes in Japan were enrolled. Two interim analyses and final analysis were performed in October 2014, May 2018, and November 2021, respectively. Interventions: Patients were randomly assigned (1:1) to either the ODG or LADG group. The procedures were performed exclusively by qualified surgeons. Main Outcomes and Measures: The primary end point was 5-year relapse-free survival, and the noninferiority margin for the hazard ratio (HR) was set at 1.31. The secondary end points were 5-year overall survival and safety. Results: A total of 502 patients were included in the full-analysis set: 254 (50.6%) in the ODG group and 248 (49.4%) in the LADG group. Patients in the ODG group had a median (IQR) age of 67 (33-80) years and included 168 males (66.1%). Patients in the LADG group had a median (IQR) age of 64 (34-80) years and included 169 males (68.1%). No significant differences were observed in severe postoperative complications between the 2 groups in the safety analysis (ODG, 4.7% [11 of 233] vs LADG, 3.5% [8 of 227]; P = .64). The median (IQR) follow-up for all patients after randomization was 67.9 (60.3-92.0) months. The 5-year relapse-free survival was 73.9% (95% CI, 68.7%-79.5%) and 75.7% (95% CI, 70.5%-81.2%) for the ODG and LADG groups, respectively, and the HR was 0.96 (90% CI, 0.72-1.26; noninferiority 1-sided P = .03). Further, no significant difference was observed in overall survival time between the 2 groups, and the HR was 0.83 (95% CI, 0.57-1.21; P = .34). The pattern of recurrence was similar between the 2 groups. Conclusions and Relevance: Results of this study show that on the basis of 5-year follow-up data, LADG with D2 lymph node dissection for locally advanced gastric cancer, when performed by qualified surgeons, was proved noninferior to ODG. This laparoscopic approach could become a standard treatment for locally advanced gastric cancer. Trial Registration: UMIN Clinical Trial Registry: UMIN000003420.
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Laparoscopía , Neoplasias Gástricas , Masculino , Humanos , Anciano , Anciano de 80 o más Años , Persona de Mediana Edad , Neoplasias Gástricas/patología , Estudios Prospectivos , Complicaciones Posoperatorias/etiología , Gastrectomía/métodos , Laparoscopía/métodos , Escisión del Ganglio Linfático/métodosRESUMEN
BACKGROUND: The aim of this study was to investigate the prognostic impact of mismatch repair (MMR) status, programmed death-ligand 1 (PD-L1) expression, and Epstein-Barr virus (EBV) status in stage II/III gastric cancer after surgery. METHODS: This study included 679 patients diagnosed with pathological stage II/III gastric cancer who underwent curative gastrectomy followed by adjuvant chemotherapy (AC) or observation between 2007 and 2015. Clinical outcomes were retrospectively reviewed and compared with stratification by AC and other clinicopathological factors. RESULTS: Patients were divided into AC (n = 484) or surgery alone (SA; n = 195) groups and were further stratified by MMR and EBV status: MMR-deficient (DMMR) and MMR-proficient (PMMR) groups. Comparing the AC-DMMR group versus the AC-PMMR group, 5-year overall survival was 92.0% versus 74.0% (log-rank p < 0.01), and comparing the SA-DMMR group versus the SA-PMMR group, 5-year overall survival was 71.1% versus 73.7% (log-rank p = 0.89). DMMR (hazard ratio 0.25, 95% confidence interval 0.07-0.81) was identified as an independent prognostic factor in the AC group but not in the SA group. In the subgroup analysis, PD-L1-negative patients among the EBV-positive patients or in the DMMR group had a poor prognosis in both the AC and SA groups. The prognosis of the PMMR and EBV-negative patients was similar regardless of PD-L1 expression. CONCLUSIONS: DMMR was associated with a favorable prognosis in stage II/III gastric cancer after surgery and adjuvant therapy. PD-L1 expression may affect the prognosis of DMMR and EBV-positive gastric cancer.
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Infecciones por Virus de Epstein-Barr , Neoplasias Gástricas , Humanos , Antígeno B7-H1/metabolismo , Herpesvirus Humano 4/metabolismo , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/patología , Estudios Retrospectivos , Infecciones por Virus de Epstein-Barr/complicaciones , Pronóstico , Reparación de la Incompatibilidad de ADNRESUMEN
PURPOSE: The pathological diagnosis of surgically resected gastric cancer involves both a macroscopic diagnosis by gross observation and a microscopic diagnosis by microscopy. Macroscopic diagnosis determines the location and stage of the disease and the involvement of other organs and surgical margin. Lesion recognition is, thus, an important diagnostic step that requires a skilled pathologist. Nonetheless, artificial intelligence (AI) technologies could allow even inexperienced doctors and laboratory technicians to examine surgically resected specimens without the need for pathologists. However, organ imaging conditions vary across hospitals, and an AI algorithm created in one setting may not work properly in another. Thus, we identified and standardized factors affecting the quality of pathological macroscopic images, which could further affect lesion identification using AI. METHODS: We examined necessary image standardization for developing cancer detection AI for surgically resected gastric cancer by changing the following imaging conditions: focus, resolution, brightness, and contrast. RESULTS: Regarding focus, brightness, and contrast, the farther away the test data were from the training macro-image, the less likely the inference was to be correct. Little change was observed for resolution, even with differing conditions for the training and test data. Regarding focus, brightness, and contrast, there were conditions appropriate for AI. Contrast, in particular, was far from the conditions appropriate for humans. CONCLUSION: Standardizing focus, brightness, and contrast is important in the development of AI methodologies for lesion detection in surgically resected gastric cancer. This standardization is essential for AI to be implemented across hospitals.
Asunto(s)
Inteligencia Artificial , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/diagnóstico por imagen , Neoplasias Gástricas/cirugía , Algoritmos , Hospitales , Márgenes de EscisiónRESUMEN
BACKGROUND: Intensivists target different blood pressure component values to manage intensive care unit (ICU) patients with sepsis. We aimed to evaluate the relationship between individual blood pressure components and organ dysfunction in critically ill septic patients. METHODS: In this retrospective observational study, we evaluated 77,328 septic patients in 364 ICUs in the eICU Research Institute database. Primary exposure was the lowest cumulative value of each component; mean, systolic, diastolic, and pulse pressure, sustained for at least 120 min during ICU stay. Primary outcome was ICU mortality and secondary outcomes were composite outcomes of acute kidney injury or death and myocardial injury or death during ICU stay. Multivariable logistic regression spline and threshold regression adjusting for potential confounders were conducted to evaluate associations between exposures and outcomes. Sensitivity analysis was conducted in 4211 patients with septic shock. RESULTS: Lower values of all blood pressures components were associated with a higher risk of ICU mortality. Estimated change-points for the risk of ICU mortality were 69 mmHg for mean, 100 mmHg for systolic, 60 mmHg for diastolic, and 57 mmHg for pulse pressure. The strength of association between blood pressure components and ICU mortality as determined by slopes of threshold regression were mean (- 0.13), systolic (- 0.11), diastolic (- 0.09), and pulse pressure (- 0.05). Equivalent non-linear associations between blood pressure components and ICU mortality were confirmed in septic shock patients. We observed a similar relationship between blood pressure components and secondary outcomes. CONCLUSION: Blood pressure component association with ICU mortality is the strongest for mean followed by systolic, diastolic, and weakest for pulse pressure. Critical care teams should continue to follow MAP-based resuscitation, though exploratory analysis focusing on blood pressure components in different sepsis phenotypes in critically ill ICU patients is needed.