Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy: results of a European randomized trial.

BACKGROUND: Surgical resection with adequate lymphadenectomy is regarded the only curative option for gastric cancer. Regarding minimally invasive techniques, mainly Asian studies showed comparable oncological and short-term postoperative outcomes. The incidence of gastric cancer is lower in the Western population and patients often present with more advanced stages of disease. Therefore, the reproducibility of these Asian results in the Western population remains to be investigated. METHODS: A randomized trial was performed in thirteen hospitals in Europe. Patients with an indication for total gastrectomy who received neoadjuvant chemotherapy were eligible for inclusion and randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG). Primary outcome was oncological safety, measured as the number of resected lymph nodes and radicality. Secondary outcomes were postoperative complications, recovery and 1-year survival. RESULTS: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. The mean number of resected lymph nodes was 43.4 ± 17.3 in OTG and 41.7 ± 16.1 in MITG (p = 0.612). Forty-eight patients in the OTG group had a R0 resection and 44 patients in the MITG group (p = 0.617). One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701). No significant differences were found regarding postoperative complications and recovery. CONCLUSION: These findings provide evidence that MITG after neoadjuvant therapy is not inferior regarding oncological quality of resection in comparison to OTG in Western patients with resectable gastric cancer. In addition, no differences in postoperative complications and recovery were seen.

Las primeras experiencias en cirugía laparoscópica de colon en España. Valencia, noviembre de 1991 / The first experiences with colorectal laparoscopic surgery in Spain. Valencia, November 1991

El desarrollo de la cirugía laparoscópica de colon en nuestro país ha sido muy rápida desde su comienzo a finales de 1991. La resección de colon y recto por cirugía mínimamente invasiva ha cambiado desde sus inicios la manera de tratar a nuestros enfermos, debido esencialmente a las ventajas a corto plazo sobre la cirugía abierta, por su menor morbimortalidad y mejor calidad de vida con igualdad a largo plazo en los resultados oncológicos. En la enseñanza y difusión de estos conceptos en forma de cursos, estudios aleatorizados, artículos científicos y libros han participado y participan un ingente número de cirujanos españoles que gozan del reconocimiento internacional

The development of laparoscopic colon surgery in Spain has spread quickly since its beginnings at the end of 1991. Colorectal Minimally Invasive Surgery is widely implemented and has changed the way we treat our patients, specially due to the short-term advantages such as lower morbidity with a better quality of life with the same oncological outcomes in the long term. A huge number of Spanish surgeons have contributed to the implementation of techniques and spreading the knowledge of these concepts by means of courses, controlled randomized studies, scientific papers, and books, and have obtained international recognition

[The first experiences with colorectal laparoscopic surgery in Spain. Valencia, November 1991]. / Las primeras experiencias en cirugía laparoscópica de colon en España. Valencia, noviembre de 1991.

The development of laparoscopic colon surgery in Spain has spread quickly since its beginnings at the end of 1991. Colorectal Minimally Invasive Surgery is widely implemented and has changed the way we treat our patients, specially due to the short-term advantages such as lower morbidity with a better quality of life with the same oncological outcomes in the long term. A huge number of Spanish surgeons have contributed to the implementation of techniques and spreading the knowledge of these concepts by means of courses, controlled randomized studies, scientific papers, and books, and have obtained international recognition.

Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial.

BACKGROUND: Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less perioperative blood loss and faster patient recovery. It also maintains similar results with regard to tumor resection margins and oncological long-term survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, with a free margin of 5 to 6 cm from the tumor, combined with a lymphadenectomy. The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, it is imperative that a novel surgical technique, such as minimally invasive total gastrectomy, should be non-inferior with regard to radicality of surgery and lymph node yield. METHODS/DESIGN: The Surgical Techniques, Open versus Minimally invasive gastrectomy After CHemotherapy (STOMACH) study is a randomized, clinical multicenter trial. All adult patients with primary carcinoma of the stomach, in which the tumor is considered surgically resectable (T1-3, N0-1, M0) after neo-adjuvant chemotherapy, are eligible for inclusion and randomization. The primary endpoint is quality of oncological resection, measured by radicality of surgery and number of retrieved lymph nodes. The pathologist is blinded towards patient allocation. Secondary outcomes include patient-reported outcomes measures (PROMs) regarding quality of life, postoperative complications and cost-effectiveness. Based on a non-inferiority model for lymph node yield, with an average lymph node yield of 20, a non-inferiority margin of -4 and a 90% power to detect non-inferiority, a total of 168 patients are to be included. DISCUSSION: The STOMACH trial is a prospective, multicenter, parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy: the conventional 'open' approach or minimally invasive total gastrectomy. TRIAL REGISTRATION: This trial was registered on 28 April 2014 at Clinicaltrials.gov with the identifier NCT02130726 .

Utilización de adhesivos biológicos a base de fibrina en la prevención de fugas anastomóticas en anastomosis del tubo digestivo de alto riesgo: resultados preliminares del ensayo clínico fase iv multicéntrico, prospectivo, aleatorizado y controlado simple ciego: Protissucol001 / Use of fibrin based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract: preliminary results of the multicentre, prospective, randomised, controlled, and simple blind phase IV clinical trial: Protissucol001

Introducción: Con el objetivo de demostrar la eficacia de los adhesivos biológicos a base de fibrina en la prevención de fugas anastomóticas, en enero de 2007 iniciamos un estudio multicéntrico, prospectivo, aleatorizado, controlado, simple ciego, sobre la prevención de fugas anastomóticas en anastomosis del tubo digestivo de alto riesgo mediante la utilización de adhesivos biológicos a base de fibrina. Material y métodos En enero de 2007 iniciamos un ensayo clínico multicéntrico en el que participan los hospitales Gregorio Marañón, Universitario de San Carlos y Hospital del Sureste, de Madrid sobre la prevención de defectos de cicatrización anastomótica mediante la aplicación de adhesivos biológicos a base de fibrina en la linea de sutura. Los pacientes reclutados se aleatorizan asignando al paciente en función de esta aleatorización a uno de los 2 grupos: grupo de estudio en el que se aplica adhesivo en la línea de sutura y grupo control en el que no se aplica. La variable principal del estudio es la presencia o ausencia de fugas. El ensayo ha sido aprobado por los correspondientes Comités de Ética e Investigación Clínica, por la Agencia Española del Medicamento y registrado en www.clinicaltrials.gov (NCT01306851). Ninguno de los autores manifiesta tener conflicto de interés con la empresa Baxter, que comercializa el producto en España. Resultados Desde enero de 2007 hasta noviembre de 2010, se ha reclutado a 104 pacientes que han sido asignados tras aleatorización, 52 al grupo de estudio y 52 al grupo control. Se han registrado 22 fugas anastomóticas de las cuales 7 en el grupo de estudio (13, 4%) y 15 en el grupo control (28, 8%) con un valor de la P de 0,046. El índice de riesgo de fugas fue de 0,384, es decir, se produce una reducción del 61% en las fugas de los pacientes a los que se aplica adhesivo biológico a (..) (AU)

Introduction: A multicentre, prospective, randomised, controlled, and simple blind clinicaltrial was started in January 2007, with the aim of demonstrating the eficacy of fibrin-based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract. Material and methods: A study on the prevention of anastomotic healing defects by applying biological adhesives along the suture line began in January 2007, and included the hospitals, Gregorio Marañón, Universitario de San Carlos, and Hospital del Sureste, in Madrid. The enrolled patients were randomised to one of 2 groups: the study group in which the adhesive was applied to the suture line, and a control group in which it was not applied. The primary outcome of the study was the presence or absence of leaks. The trial was approved by the corresponding Clinical Research Ethics Committees and the Spanish Medicines Agency(AEMPS) and registered www.clinicaltrials.gov (NCT01306851). The authors declared not to have any (..) (AU)

[Use of fibrin based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract: preliminary results of the multicentre, prospective, randomised, controlled, and simple blind phase IV clinical trial: Protissucol001]. / Utilización de adhesivos biológicos a base de fibrina en la prevención de fugas anastomóticas en anastomosis del tubo digestivo de alto riesgo: resultados preliminares del ensayo clínico fase iv multicéntrico, prospectivo, aleatorizado y controlado simple ciego: Protissucol001.

INTRODUCTION: A multicentre, prospective, randomised, controlled, and simple blind clinical trial was started in January 2007, with the aim of demonstrating the efficacy of fibrin-based biological adhesives in the prevention of anastomotic leaks in the high risk digestive tract. MATERIAL AND METHODS: A study on the prevention of anastomotic healing defects by applying biological adhesives along the suture line began in January 2007, and included the hospitals, Gregorio Marañón, Universitario de San Carlos, and Hospital del Sureste, in Madrid. The enrolled patients were randomised to one of 2 groups: the study group in which the adhesive was applied to the suture line, and a control group in which it was not applied. The primary outcome of the study was the presence or absence of leaks. The trial was approved by the corresponding Clinical Research Ethics Committees and the Spanish Medicines Agency (AEMPS) and registered www.clinicaltrials.gov (NCT01306851). The authors declared not to have any conflict of interests with the company, Baxter, which markets the product in Spain. RESULTS: A total of 104 patients were recruited between January 2007 and November 2010, of whom 52 were randomised to the study group, and 52 to the control group. A total of 22 anastomotic leaks were recorded, of which 7 (13.4%) were in the study group, and 15 (28.8%) in the control group (P=.046). The leak risk index was 0.384, which means that there was a 61% reduction in leaks in the patients who had the fibrin-based biological adhesive applied. There were 3 (5.7%) further surgeries in the study group, compared to 12 (23%) in the control group (P=.12). On analysing the mortality, it was observed that 3 patients in the study group and 4 patients in the control group died (5.7% vs. 7.7%, P=.5). No other significant differences were found as regards the type of suture, surgical time, or pre-surgical history, except that the use of drainages appeared to be a protective factor of anastomotic leak (P=.041), although the use or not of a drainage was not a controlled factor, but at the discretion of each surgeon. CONCLUSIONS: Our study demonstrates, significantly, that in the 104 patients in the study that fibrin based biological adhesives are capable of preventing anastomotic leaks in the high risk digestive tract, reducing the risk of leaks by 61% and a further surgeries. This is the first clinical trial that shows these significant results. If our results are maintained at the end of the study, it will show that anastomotic leaks can be prevented with the application of these adhesives, thus their application may be recommended in all the anastomosis of the high risk digestive tract.

A review of metabolic staging in severely injured patients.

An interpretation of the metabolic response to injury in patients with severe accidental or surgical trauma is made. In the last century, various authors attributed a meaning to the post-traumatic inflammatory response by using teleological arguments. Their interpretations of this response, not only facilitates integrating the knowledge, but also the flow from the bench to the bedside, which is the main objective of modern translational research. The goal of the current review is to correlate the metabolic changes with the three phenotypes -ischemia-reperfusion, leukocytic and angiogenic- that the patients express during the evolution of the systemic inflammatory response. The sequence in the expression of multiple metabolic systems that becomes progressively more elaborate and complex in severe injured patients urges for more detailed knowledge in order to establish the most adequate metabolic support according to the evolutive phase. Thus, clinicians must employ different treatment strategies based on the different metabolic phases when caring for this challenging patient population. Perhaps, the best therapeutic option would be to favor early hypometabolism during the ischemia-reperfusion phase, to boost the antienzymatic metabolism and to reduce hypermetabolism during the leukocytic phase through the early administration of enteral nutrition and the modulation of the acute phase response. Lastly, the early epithelial regeneration of the injured organs and tissues by means of an oxidative metabolism would reduce the fibrotic sequelae in these severely injured patients.

Fístula gastrocólica por adenocarcinoma gástrico / Gastrocolonic fistula due to gastric adenocarcinoma

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