RESUMEN
BACKGROUND: Robotic gastrectomy is a safe and feasible approach for gastric cancer (GC); however, its long-term oncological efficacy remains unclear. The authors evaluated the long-term survival outcomes and recurrence patterns of patients with locally advanced proximal GC who underwent robotic total gastrectomy (RTG). METHODS: This prospective study (FUGES-014 study) enrolled 48 patients with locally advanced proximal GC who underwent RTG between March 2018 and February 2020 at a tertiary referral teaching hospital. Patients who underwent laparoscopic total gastrectomy (LTG) in the FUGES-002 study were enrolled in a 2:1 ratio to compare the survival outcomes between RTG and LTG. The primary endpoint of the FUGES-014 study was postoperative 30-day morbidity and has been previously reported. Here, the authors reported the results of 3-year disease-free survival (DFS), 3-year overall survival (OS), and recurrence patterns. RESULTS: After propensity score matching, 48 patients in the RTG and 96 patients in the LTG groups were included. The 3-year DFS rates were 77.1% (95% CI: 66.1-89.9%) for the RTG and 68.8% (95% CI: 60.1-78.7%) for the LTG groups ( P =0.261). The 3-year OS rates were not significantly different between the groups (85.4 vs. 74.0%, P =0.122). Recurrence occurred in nine patients (18.8%) in the RTG and 27 (28.1%) patients in the LTG groups ( P =0.234). Recurrence patterns and causes of death were similar between the groups ( P >0.05). CONCLUSIONS: The oncological outcome of RTG was noninferior to that of LTG. Thus, RTG might be an alternative surgical treatment for locally advanced proximal GC.
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Gastrectomía , Procedimientos Quirúrgicos Robotizados , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/mortalidad , Neoplasias Gástricas/patología , Gastrectomía/métodos , Gastrectomía/mortalidad , Procedimientos Quirúrgicos Robotizados/mortalidad , Procedimientos Quirúrgicos Robotizados/métodos , Masculino , Femenino , Estudios Prospectivos , Persona de Mediana Edad , Anciano , Puntaje de Propensión , Resultado del Tratamiento , Recurrencia Local de Neoplasia , Supervivencia sin Enfermedad , Laparoscopía/mortalidad , Tasa de SupervivenciaRESUMEN
BACKGROUND: Indocyanine green (ICG) fluorescence imaging is effective in increasing the number of lymph node dissections during laparoscopic radical gastrectomy; however, no studies have attempted to explain this phenomenon. METHODS: This study utilized the data from a previous randomized controlled trial (FUGES-012 study) investigating ICG-guided laparoscopic radical gastrectomy performed between November 2018 and July 2019. The Objective Structured Assessments of Technical Skills (OSATS) scoring system was used to grade videos from the ICG and non-ICG groups. Patients with an OSATS score greater than 29 were classified as the high-OSATS population, while those with an OSATS score less than or equal to 29 were classified as the low-OSATS population. RESULTS: A total of 258 patients were included in the modified intention-to-treat analysis: 129 in the ICG group and 129 in the non-ICG group. The OSATS score of the ICG group was higher than that of the non-ICG group (29.6±2.6 vs. 26.6±3.6; P <0.001). The ICG group underwent a significantly higher mean total number of lymph node dissections than the non-ICG group (50.5±15.9 vs. 42.0±10.3; adjusted P <0.001). The group assigned to ICG use, better OSATS (high-OSATS) scores were observed, which correlated with greater D2 lymph node retrieval (54.1±15.0 vs. 47.2±8.7; adjusted P =0.039). Finally, the ICG group had a lower rate of lymph node noncompliance than that of the non-ICG group (31.8 vs. 57.4%; P <0.001). CONCLUSIONS: By applying the ICG fluorescence navigation technique, better OSATS scores were observed, which correlated with greater lymph node retrieval and a lower lymph node noncompliance rate, as recommended for individualized laparoscopic radical gastrectomy.
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Laparoscopía , Neoplasias Gástricas , Humanos , Verde de Indocianina , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/patología , Escisión del Ganglio Linfático/métodos , Ganglios Linfáticos/patología , Laparoscopía/métodos , Gastrectomía/métodos , Biopsia del Ganglio Linfático Centinela/métodosRESUMEN
BACKGROUND: The results of several large randomized controlled trials (RCTs) have changed the clinical practice of bariatric surgery. However, the characteristics of global RCTs of bariatric surgery have not been reported internationally and whether there was research waste in these RCTs is unknown. METHODS: Search ClinicalTrials.gov for bariatric surgery RCTs registered between January 2000 and December 2022 with the keywords 'Roux-en-Y gastric-bypass' and 'Sleeve Gastrectomy'. The above analysis was conducted in January 2023. RESULTS: A total of 326 RCTs were included in this study. The number of RCTs registered for sleeve gastrectomy and gastric bypass surgery increased year by year globally. Europe has always accounted for the largest proportion, Asia has gradually increased, and North America has decreased. A total of 171 RCTs were included in the analysis of waste, of which 74 (43.8%) were published. Of the 74 published RCTs, 37 (37/74, 50.0%) were judged to be adequately reported and 36 (36/74, 48.6%) were judged to have avoidable design defects. In the end, 143 RCTs (143/171, 83.6%) had at least one research waste. Body weight change as the primary endpoint (OR: 0.266, 95% CI: 0.103-0.687, P =0.006) and enrolment greater than 100 (OR: 0.349, 95% CI: 0.146-0.832, P =0.018) were independent protective factors for research waste. CONCLUSIONS: This study for the first time describes the characteristic changes of the mainstream RCT of bariatric surgery globally in the last 20 years and identifies a high research waste burden and predictive factor in this area, which provides reference evidence for carrying out bariatric surgery RCTs more rationally.
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Cirugía Bariátrica , Derivación Gástrica , Laparoscopía , Obesidad Mórbida , Humanos , Obesidad Mórbida/cirugía , Estudios Transversales , Pérdida de Peso , Ensayos Clínicos Controlados Aleatorios como Asunto , Derivación Gástrica/métodos , Gastrectomía/métodos , Resultado del Tratamiento , Laparoscopía/métodosRESUMEN
BACKGROUND: The impact of achieving textbook oncological outcome (TOO) as a multimodal therapy quality indicator on the prognosis of advanced gastric cancer (AGC) remains inadequately assessed. METHODS: Patients with AGC who underwent curative gastrectomy between January 2010 and December 2017 at two East Asian medical centers were included. TOO was defined as achieving the textbook outcome (TO) and receiving neoadjuvant and/or adjuvant chemotherapy (NCT or ACT). Cox and logistic regression models were used to identify prognostic and non-TOO-associated risk factors. RESULTS: Among 3626 patients, 57.6% achieved TOO (TOO group), exhibiting significantly better 5-year overall survival (OS) and disease-free survival (DFS) than the non-TOO group (both p < 0.05). Multivariate Cox regression identified TOO as an independent prognostic factor for 5-year OS (HR, 0.67; 95% CI, 0.61-0.74; p < 0.001) and DFS (HR, 0.73; 95% CI, 0.66-0.81; p < 0.001). Multivariate logistic regression showed that open gastrectomy, lack of health insurance, age ≥65 years, ASA score ≥ â ¢, and tumor size ≥50 mm are independent risk factors for non-achievement of TOO (all p < 0.05). On a sensitivity analysis of TOO's prognostic value using varying definitions of chemotherapy parameters, a stricter definition of chemotherapy resulted in a decrease in the TOO achievement rate from 57.6 to 22.3%. However, the associated reductions in the risk of death and recurrence fluctuated within the ranges of 33-39% and 28-37%, respectively. CONCLUSIONS: TOO is a reliable and stable metric for favorable prognosis in AGC. Optimizing the surgical approach and improving health insurance status may enhance TOO achievement.
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Gastrectomía , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/patología , Masculino , Femenino , Persona de Mediana Edad , Pronóstico , Anciano , Quimioterapia Adyuvante , Tasa de Supervivencia , Terapia Neoadyuvante , Estudios Retrospectivos , Supervivencia sin Enfermedad , Estadificación de Neoplasias , Factores de Riesgo , Adulto , Resultado del TratamientoRESUMEN
INTRODUCTION: Prognostic factors for postoperative early recurrence (ER) of gastric cancer (GC) in patients with normal or abnormal preoperative tumor markers (pre-TMs) remain unclear. MATERIALS AND METHODS: 2875 consecutive patients with GC who underwent radical gastrectomy (RG) between January 2010 and December 2016 were enrolled and randomly divided into training and internal validation groups. ER was defined as recurrence within two years of gastrectomy. Normal pre-TMs were defined as CEA≤5 ng/mL and CA199 ≤ 37 U/mL. Least absolute shrinkage selection operator (LASSO) Cox regression analysis was used to screen ER predictors. The scoring model was validated using 546 patients from another hospital. RESULTS: A total of 3421 patients were included. Multivariate Cox analysis showed that pre-TMs was an independent prognostic factor for ER. Survival after ER was equally poor in the normal and abnormal pre-TMs groups (P = 0.160). Based on LASSO Cox regression, the ER of patients with abnormal pre-TMs was only associated with the pT and pN stages; however, in patients with normal pre-TMs, it was also associated with tumor size, perineural invasion, and prognostic nutritional index. Scoring model constructed for patients with normal pre-TMs had better predictive performance than TNM staging (concordance-index:0.826 vs. 0.807, P < 0.001) and good reproducibility in both validation sets. Moreover, through risk stratification, the scoring model could not only identify the risk of ER but also distinguish ER patterns and adjuvant chemotherapy benefit subgroups. CONCLUSION: pre-TMs is an independent prognostic factor for ER in GC after RG. The established scoring model demonstrates excellent predictive performance and clinical utility.
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Biomarcadores de Tumor , Neoplasias Gástricas , Humanos , Pronóstico , Neoplasias Gástricas/patología , Reproducibilidad de los Resultados , Estudios Retrospectivos , GastrectomíaRESUMEN
BACKGROUND: Few studies have reported the association between the pattern and time point of recurrence in different groups stratified by age in postoperative survival of patients with gastric cancer. METHODS: The clinicopathological data and recurrence data of 2028 patients with GC who underwent curative surgery from January 2010 to March 2015 were enrolled in this study. Patients were grouped according to age: young group (YG) (≤45 years old) (n = 180) and non-young group (OG) (>45 years old) (n = 1848). RESULTS: A total of 2028 patients were enrolled. The young group had better 5-year OS and DFS than the non-young group. In peritoneal recurrence, the cumulative incidence of recurrence in YG was higher than that in OG (P < 0.001). In distant recurrence, the cumulative incidence of recurrence YG was always lower than that of OG (P = 0.004). Recurrence hazard function varied over time between the two groups:in the peritoneal metastasis, the recurrence hazard for YG was higher and earlier than that of OG and the YG was observed during five years after surgery with two recurrence peaks in 8.5 months and in 41.5 months. In distant recurrence, the recurrence hazard for OG had an earlier and higher single peak than that of YG (6.0 months). CONCLUSION: The recurrence characteristics of patients with gastric cancer after curative resection between young group and older group are different. Personalized follow-up strategies should be developed according to the age and time point after operation for the early detection of recurrence and making decision for further treatment.