Recurrence and Survival after Minimally Invasive and Open Esophagectomy for Esophageal Cancer - A Post Hoc Analysis of the Ensure Study.

OBJECTIVE: The aim of this study was to determine the impact of operative approach (open [OE], hybrid [HMIE] and total minimally invasive esophagectomy [TMIE]) on operative and oncologic outcomes for patients treated with curative intent for esophageal and junctional cancer. SUMMARY BACKGROUND DATA: The optimum oncologic surgical approach to esophageal and junctional cancer is unclear. METHODS: This secondary analysis of the European multicenter ENSURE study includes patients undergoing curative-intent esophagectomy for cancer between 2009-2015 across 20 high-volume centers. Primary endpoints were disease-free survival (DFS) and the incidence and location of disease recurrence. Secondary endpoints included among others R0 resection rate, lymph node yield and overall survival (OS). RESULTS: In total, 3,199 patients were included. Of these, 55% underwent OE, 17% HMIE and 29% TMIE. DFS was independently increased post TMIE (HR 0.86 [95% CI 0.76-0.98], P=0.022) compared with OE. Multivariable regression demonstrated no difference in absolute locoregional recurrence risk according to operative approach (HMIE vs. OE OR 0.79, P=0.257, TMIE vs. OE OR 0.84, P=0.243). The probability of systemic recurrence was independently increased post HMIE (OR 2.07, P=0.031), but not TMIE (OR 0.86, P=0.508). R0 resection rates (P=0.005) and nodal yield (P<0.001) were independently increased after TMIE, but not HMIE (P=0.424; P=0.512) compared with OE. OS was independently improved following both HMIE (HR 0.79, P=0.009) and TMIE (HR 0.82, P=0.003) as compared with OE. CONCLUSION: In this European multicenter study, TMIE was associated with improved surgical quality and DFS, while both TMIE and HMIE were associated with improved OS as compared with OE for esophageal cancer.

Western European Variation in the Organization of Esophageal Cancer Surgical Care.

Reasons for structural and outcome differences in esophageal cancer surgery in Western Europe remain unclear. This questionnaire study aimed to identify differences in the organization of esophageal cancer surgical care in Western Europe. A cross-sectional international questionnaire study was conducted among upper gastrointestinal (GI) surgeons from Western Europe. One surgeon per country was selected based on scientific output and active membership in the European Society for Diseases of the Esophagus or (inter)national upper GI committee. The questionnaire consisted of 51 structured questions on the structural organization of esophageal cancer surgery, surgical training, and clinical audit processes. Between October 2021 and October 2022, 16 surgeons from 16 European countries participated in this study. In 5 countries (31%), a volume threshold was present ranging from 10 to 26 annual esophagectomies, in 7 (44%) care was centralized in designated centers, and in 4 (25%) no centralizing regulations were present. The number of centers performing esophageal cancer surgery per country differed from 4 to 400, representing 0.5-4.9 centers per million inhabitants. In 4 countries (25%), esophageal cancer surgery was part of general surgical training and 8 (50%) reported the availability of upper GI surgery fellowships. A national audit for upper GI surgery was present in 8 (50%) countries. If available, all countries use the audit to monitor the quality of care. Substantial differences exist in the organization and centralization of esophageal cancer surgical care in Western Europe. The exchange of experience in the organizational aspects of care could further improve the results of esophageal cancer surgical care in Europe.

El registro continuado de los efectos adversos mejora los resultados quirúrgicos / Continuous monitoring of adverse effects improves surgical outcomes

Antecedentes: Se ha debatido mucho sobre las ventajas e inconvenientes del uso de bases administrativas o de registros clínicos en los programas de mejora de la atención médica. El objetivo de este estudio ha sido revisar la implementación y los resultados de una política de evaluación continua, mediante un registro mantenido por profesionales de un Servicio de Cirugía. Material y métodos: Se incluyeron, de forma prospectiva, todos los pacientes ingresados en el servicio entre los años 2003 y 2022. Se anotaron todos los efectos adversos (EA) acaecidos durante el ingreso, la estancia en centros de convalecencia o en su domicilio durante un periodo mínimo de 30 días tras el alta. Resultados: De 60.125 registros, en 16.802 (27,9%) se registraron 24.846 EA. Hubo un aumento progresivo del número de EA registrados por ingreso (1,17 en 2003 vs. 1,93 en 2022) con una disminución de 26% de los registros con EA (35% en 2003 hasta 25,8% en 2022), de 57,5% en las reoperaciones (de 8 a 3,4%, respectivamente), y de 80% en la mortalidad (de 1,8 a 1%, respectivamente). Es de remarcar la reducción significativa de los EA graves, observada entre los años 2011 y el 2022 (56 vs. 15,6%). Conclusión: Un registro prospectivo de EA creado y mantenido por profesionales del servicio, junto con la presentación y discusión abierta y trasparente de los resultados, produce una mejora sostenida de los resultados en un servicio quirúrgico de un hospital universitario.(AU)

Background: There has been significant debate about the advantages and disadvantages of using administrative databases or clinical registries in healthcare improvement programs. The aim of this study was to review the implementation and outcomes of an accountability policy through a registry maintained by professionals of the surgical department.Materials and methods: All patients admitted to the department between 2003 and 2022 were prospectively included. All adverse events (AEs) occurring during the admission, convalescent care in facilities, or at home for a minimum period of 30 days after discharge were recorded. Results: Out of 60,125 records, 24,846 AEs were documented in 16,802 cases (27.9%). There was a progressive increase in the number of AEs recorded per admission (1.17 in 2003 vs. 1.93 in 2022) with a 26% decrease in entries with AEs (from 35% in 2003 to 25.8% in 2022), a 57.5% decrease in reoperations (from 8.0% to 3.4%, respectively), and an 80% decrease in mortality (from 1.8% to 1%, respectively). It is noteworthy that a significant reduction in severe AEs was observed between 2011 and 2022 (56% vs. 15.6%). Conclusion: A prospective registry of AEs created and maintained by health professionals, along with transparent presentation and discussion of the results, leads to sustained improvement in outcomes in a surgical department of a university hospital.(AU)

Continuous monitoring of adverse effects improves surgical outcomes.

BACKGROUND: There has been significant debate about the advantages and disadvantages of using administrative databases or clinical registry in healthcare improvement programs. The aim of this study was to review the implementation and outcomes of an accountability policy through a registry maintained by professionals of the surgical department. MATERIALS AND METHODS: All patients admitted to the department between 2003 and 2022 were prospectively included. All adverse events (AEs) occurring during the admission, convalescent care in facilities, or at home for a minimum period of 30 days after discharge were recorded. RESULTS: Out of 60,125 records, 24,846 AEs were documented in 16,802 cases (27.9%). There was a progressive increase in the number of AEs recorded per admission (1.17 in 2003 vs. 1.93 in 2022) with a 26% decrease in entries with AEs (from 35.0% in 2003 to 25.8% in 2022), a 57.5% decrease in reoperations (from 8.0% to 3.4%, respectively), and an 80% decrease in mortality (from 1.8% to 1.0%, respectively). It is noteworthy that a significant reduction in severe AEs was observed between 2011 and 2022 (56% vs. 15.6%). CONCLUSION: A prospective registry of AEs created and maintained by health professionals, along with transparent presentation and discussion of the results, leads to sustained improvement in outcomes in a surgical department of a university hospital.

Effects of Preoperative Quadruple Therapy for Helicobacter pylori on Bariatric Surgery Metabolic Outcomes.

PURPOSE: To assess the effects of Helicobacter pylori (HP) eradication with an omeprazole, clarithromycin, amoxicillin, and metronidazole (OCAM) regimen on the metabolic profile and weight loss 12 months after bariatric surgery (BS). METHODS: Retrospective analysis of a prospective cohort of patients with morbid obesity undergoing BS. HP presence was tested preoperatively by gastric biopsy and treated with OCAM when positive. Short-term metabolic outcomes and weight loss were evaluated. RESULTS: HP infection was detected in 75 (45.7%) of the 164 patients included. OCAM effectiveness was 90.1%. HP-negative patients had a greater reduction in glucose levels at 3 (-14.6 ± 27.5 mg/dL HP-treated vs -22.0 ± 37.1 mg/dL HP-negative, p=0.045) and 6 months (-13.7 ± 29.4 mg/dL HP-treated vs -26.4 ± 42.6 mg/dL HP-negative, p= 0.021) and greater total weight loss (%TWL) at 6 (28.7 ± 6.7% HP-treated vs 30.45 ± 6.48% HP-negative, p= 0.04) and 12 months (32.21 ± 8.11% HP-treated vs 35.14 ± 8.63% HP-negative, p= 0.023). CONCLUSIONS: Preoperative treatment with OCAM has been associated to poorer glycemic and weight loss outcomes after BS. More research is needed on the influence of OCAM on gut microbiota, and in turn, the effect of the latter on metabolic and weight loss outcomes after BS.

Clinical Features of Gastric Signet Ring Cell Cancer: Results from a Systematic Review and Meta-Analysis.

BACKGROUND: Conflicting results about the prognostic relevance of signet ring cell histology in gastric cancer have been reported. We aimed to perform a meta-analysis focusing on the clinicopathological features and prognosis of this subgroup of cancer compared with other histologies. METHODS: A systematic literature search in the PubMed database was conducted, including all publications up to 1 October 2021. A meta-analysis comparing the results of the studies was performed. RESULTS: A total of 2062 studies referring to gastric cancer with signet ring cell histology were identified, of which 262 studies reported on its relationship with clinical information. Of these, 74 were suitable to be included in the meta-analysis. A slightly lower risk of developing nodal metastases in signet ring cell tumours compared to other histotypes was found (especially to undifferentiated/poorly differentiated/mucinous and mixed histotypes); the lower risk was more evident in early and slightly increased in advanced gastric cancer. Survival tended to be better in early stage signet ring cell cancer compared to other histotypes; no differences were shown in advanced stages, and survival was poorer in metastatic patients. In the subgroup analysis, survival in signet ring cell cancer was slightly worse compared to non-signet ring cell cancer and differentiated/well-to-moderately differentiated adenocarcinoma. CONCLUSIONS: Most of the conflicting results in signet ring cell gastric cancer literature could be derived from the lack of standardisation in their classification and the comparison with the different subtypes of gastric cancer. There is a critical need to strive for a standardised classification system for gastric cancer, fostering clarity and coherence in the forthcoming research and clinical applications.

YAP Activation Is Associated with a Worse Prognosis of Poorly Cohesive Gastric Cancer.

Poorly cohesive (PC) gastric cancer (GC) is extremely aggressive in progression, and there is an urgent need to identify the molecular pathways involved. We hypothesized the essential role of the RhoA-YAP axis in these mechanisms. The present observational multicenter retrospective study included 133 patients with PC GC treated at two dedicated European surgical centers between 2004 and 2014. YAP nuclear localization was measured by immunohistochemical (IHC) analysis of tissue biopsies. The complete absence of nuclear reactivity was coded as negative expression; we considered "any positive" as low nuclear expression (>0% but <10% of cells) and high nuclear expression (≥10% of cells). Women represented about half of the present series (52%), and the median age was 64 years (p25-p75 range: 53-75). Neoadjuvant and adjuvant treatments were administered to 10% and 54% of the cases, respectively. Extended systemic lymphadenectomy (D2) was the most common (54%). In nearly all cases, the number of retrieved nodes was ≥15, i.e., adequate for tumor staging (94%). An R0 resection was achieved in 80% of the cases. Most patients were pathological T stage 3 and 4 (pT3/pT4 = 79.0%) and pathological N stage 2, 3a, and 3b (pN2/pN3a/pN3b = 47.0%) at the pathological examination. Twenty patients (15%) presented distant metastases. Five-year overall survival (OS) was significantly higher (p = 0.029) in patients with negative YAP (46%, 95% CI 31.1-60.0%) than in the other patients (27%, 17.5-38.1%). Moreover, when controlling for sex, age, pT, pN, and percentage of signet ring cells in the multivariable analysis, YAP expression was a significant predictor of OS (HR 2.03, 95% CI: 1.18-3.51, p = 0.011). Our results provide new insights into the role of the YAP signaling cascade, as its activation was associated with a worse prognosis in PC GC.

Textbook Oncological Outcome in European GASTRODATA.

OBJECTIVE: To assess the rate of textbook outcome (TO) and textbook oncological outcome (TOO) in the European population based on the GASTRODATA registry. BACKGROUND: TO is a composite parameter assessing surgical quality and strongly correlates with improved overall survival. Following the standard of treatment for locally advanced gastric cancer, TOO was proposed as a quality and optimal multimodal treatment parameter. METHODS: TO was achieved when all the following criteria were met: no intraoperative complications, radical resection according to the surgeon, pR0 resection, retrieval of at least 15 lymph nodes, no severe postoperative complications, no reintervention, no admission to the intensive care unit, no prolonged length of stay, no postoperative mortality and no hospital readmission. TOO was defined as TO with the addition of perioperative chemotherapy compliance. RESULTS: Of the 2558 patients, 1700 were included in the analysis. TO was achieved in 1164 (68.5%) patients. The use of neoadjuvant chemotherapy [odds ratio (OR) = 1.33, 95% CI: 1.04-1.70] and D2 or D2+ lymphadenectomy (OR = 1.55, 95% CI: 1.15-2.10) had a positive impact on TO achievement. Older age (OR = 0.73, 95% CI: 0.54-0.94), pT3/4 (OR = 0.79, 95% CI: 0.63-0.99), ASA 3/4 (OR = 0.68, 95% CI: 0.54-0.86) and total gastrectomy (OR = 0.56, 95% CI: 0.45-0.70), had a negative impact on TO achievement. TOO was achieved in 388 (22.8%) patients. Older age (OR = 0.37, 95% CI: 0.27-0.53), pT3 or pT4 (OR = 0.52, 95% CI: 0.39-0.69), and ASA 3 or 4 (OR = 0.58, 95% CI: 0.43-0.79) had a negative impact on TOO achievement. CONCLUSIONS: Despite successively improved surgical outcomes, stage-appropriate chemotherapy in adherence to the current guidelines for multimodal treatment of gastric cancer remains poor. Further implementation of oncologic quality metrics should include greater emphasis on perioperative chemotherapy and adequate lymphadenectomy.

5-Year Collis-Nissen Gastroplasty Outcomes for Type III-IV Hiatal Hernia with Short Esophagus: A Prospective Observational Study.

BACKGROUND: To assess the 5-year outcomes of patients undergoing Collis-Nissen gastroplasty for type III-IV hiatal hernia with short esophagus. STUDY DESIGN: From a prospective observational cohort of patients who underwent antireflux surgery for type III-IV hiatal hernia between 2009 and 2020, those with short esophagus (abdominal length <2.5 cm) in whom a Collis-Nissen procedure was performed and reached at least 5 years of follow-up were identified. Hernia recurrence, patients' symptoms, and quality of life were assessed annually by barium meal x-ray, upper endoscopy, and validated symptoms and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaires. RESULTS: Of the 114 patients with Collis-Nissen gastroplasty, 80 patients who completed a 5-year follow-up were included (mean age 71 years). There were no postoperative leaks or deaths. Recurrent hiatal hernia (any size) was identified in 7 patients (8.8%). Heartburn, regurgitation, chest pain, and cough were significantly improved at each follow-up interval (p < 0.05). Preoperative dysphagia disappeared or improved in 26 of 30 patients, while new-onset dysphagia occurred in 6. Mean postoperative QOLRAD scores significantly improved at all dimensions (p < 0.05). CONCLUSIONS: Collis gastroplasty combined with Nissen fundoplication provides low hernia recurrence, good control of symptoms, and improved quality of life in patients with large hiatal hernia and short esophagus.

Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgery.

Large hiatus hernias with a significant paraesophageal component (types II-IV) have a range of insidious symptoms. Management of symptomatic hernias includes conservative treatment or surgery. Currently, there is no paraesophageal hernia disease-specific symptom questionnaire. As a result, many clinicians rely on the health-related quality of life questionnaires designed for gastro-esophageal reflux disease (GORD) to assess patients with hiatal hernias pre- and postoperatively. In view of this, a paraesophageal hernia symptom tool (POST) was designed. This POST questionnaire now requires validation and assessment of clinical utility. Twenty-one international sites will recruit patients with paraesophageal hernias to complete a series of questionnaires over a five-year period. There will be two cohorts of patients-patients with paraesophageal hernias undergoing surgery and patients managed conservatively. Patients are required to complete a validated GORD-HRQL, POST questionnaire, and satisfaction questionnaire preoperatively. Surgical cohorts will also complete questionnaires postoperatively at 4-6 weeks, 6 months, 12 months, and then annually for a total of 5 years. Conservatively managed patients will repeat questionnaires at 1 year. The first set of results will be released after 1 year with complete data published after a 5-year follow-up. The main results of the study will be patient's acceptance of the POST tool, clinical utility of the tool, assessment of the threshold for surgery, and patient symptom response to surgery. The study will validate the POST questionnaire and identify the relevance of the questionnaire in routine management of paraesophageal hernias.

State of the art of enhanced recovery after surgery (ERAS) protocols in esophagogastric cancer surgery: the Western experience.

Enhanced recovery after surgery (ERAS) programs provide a framework to standardize care processes and improve outcomes. The results of this multimodal and multidisciplinary approach based on actions focused on reducing physiological surgical stress in the preoperative, intraoperative, and postoperative periods are beneficial in reducing morbidity and hospital stay, without increasing readmissions across different surgical settings. The implementation of ERAS in resection procedures of esophageal and gastric cancer has been challenging due to the complexity of these surgical techniques and the high risk of complications. Despite the limited evidence of ERAS in esophagectomy operations, systematic reviews and meta-analysis have confirmed a reduction of pulmonary complications and hospital stay without increasing readmissions. In gastrectomy operations, the implementation of ERAS reduces the use of nasogastric tubes and intraabdominal drains, facilitates early diet, and reduces the length of hospital stay, without increasing complications. There is, however, wide heterogeneity and absence of standardization in the number and definition of the ERAS components. The development of ERAS consensus guidelines including procedure-specific components may reduce this variability. Regardless growing evidence of the effectiveness of ERAS, the adherence rate is still low. The commitment of the multidisciplinary team and leadership is critical in the application and refinement of ERAS protocols in parallel with periodic audits. Pre- and post-habilitation methods are emerging concepts to be incorporated in ERAS protocols.

Cost analysis of a patient blood management program for patients undergoing gastric cancer surgery.

Patient Blood Management (PBM) programs have probed to reduce blood transfusions and postoperative complications following gastric cancer resection, but evidence on their economic benefit is scarce. A recent prospective interventional study of our group described a reduction in transfusions, infectious complications and length of stay after implementation of a multicenter PBM program in patients undergoing elective gastric cancer resection with curative intent. The aim of the present study was to analyze the economic impact associated with these clinical benefits. The mean [and 95% CI] of total healthcare cost per patient was lower (-1955 [-3764, -119] €) after the PBM program implementation. The main drivers of this reduction were the hospital stay (-1847 [-3161, -553] €), blood transfusions (-100 [-145, -56] €), and post-operative complications (-162 [-718, 411] €). Total societal cost was reduced by -2243 [-4244, -210] € per patient. These findings highlight the potential economic benefit of PBM strategies.

UEG and EAES rapid guideline: Update systematic review, network meta-analysis, CINeMA and GRADE assessment, and evidence-informed European recommendations on surgical management of GERD.

BACKGROUND: There are several options for the surgical management of GERD in adults. Previous guidelines and systematic reviews have compared the effects of total fundoplication versus pooled effects of different techniques of partial fundoplication. OBJECTIVE: To develop evidence-informed, trustworthy, pertinent recommendations on the use of total, posterior partial and anterior partial fundoplications for the management of GERD in adults. METHODS: We performed an update systematic review, network meta-analysis, and evidence appraisal using the GRADE and the Confidence in Network Meta-Analysis methodologies. An international, multidisciplinary panel of surgeons, gastroenterologists, and a patient representative reached unanimous consensus through an evidence-to-decision framework to select among multiple interventions, and a Delphi process to formulate the recommendation. The project was developed in an online authoring and publication platform (MAGICapp), and was overseen by an external auditor. RESULTS: We suggest posterior partial fundoplication over total posterior or anterior 90° fundoplication in adult patients with GERD. We suggest anterior >90° fundoplication as an alternative, although relevant comparative evidence is limited (weak recommendation). The guideline, with recommendations, evidence summaries and decision aids in user friendly formats can also be accessed in MAGICapp: https://app.magicapp.org/#/guideline/j20X4n. CONCLUSION: This rapid guideline was developed in line with highest methodological standards and provides evidence-informed recommendations on the surgical management of GERD. It provides user-friendly decision aids to inform healthcare professionals' and patients' decision making.

Machine Learning Risk Prediction Model of 90-day Mortality After Gastrectomy for Cancer.

OBJECTIVE: To develop and validate a risk prediction model of 90-day mortality (90DM) using machine learning in a large multicenter cohort of patients undergoing gastric cancer resection with curative intent. BACKGROUND: The 90DM rate after gastrectomy for cancer is a quality of care indicator in surgical oncology. There is a lack of well-validated instruments for personalized prognosis of gastric cancer. METHODS: Consecutive patients with gastric adenocarcinoma who underwent potentially curative gastrectomy between 2014 and 2021 registered in the Spanish EURECCA Esophagogastric Cancer Registry database were included. The 90DM for all causes was the study outcome. Preoperative clinical characteristics were tested in four 90DM predictive models: Cross Validated Elastic regularized logistic regression method (cv-Enet), boosting linear regression (glmboost), random forest, and an ensemble model. Performance was evaluated using the area under the curve by 10-fold cross-validation. RESULTS: A total of 3182 and 260 patients from 39 institutions in 6 regions were included in the development and validation cohorts, respectively. The 90DM rate was 5.6% and 6.2%, respectively. The random forest model showed the best discrimination capacity with a validated area under the curve of 0.844 [95% confidence interval (CI): 0.841-0.848] as compared with cv-Enet (0.796, 95% CI: 0.784-0.808), glmboost (0.797, 95% CI: 0.785-0.809), and ensemble model (0.847, 95% CI: 0.836-0.858) in the development cohort. Similar discriminative capacity was observed in the validation cohort. CONCLUSIONS: A robust clinical model for predicting the risk of 90DM after surgery of gastric cancer was developed. Its use may aid patients and surgeons in making informed decisions.

Development of the ParaOesophageal hernia SympTom (POST) tool.

BACKGROUND: The aim of this study was to develop a symptom severity instrument (ParaOesophageal hernia SympTom (POST) tool) specific to para-oesophageal hernia (POH). METHODS: The POST tool was developed in four stages. The first was establishment of a Steering Committee. In the second stage, items were generated through a systematic review and online scoping survey of international experts. In the third stage, a three-round modified Delphi consensus process was conducted with a group of international experts who were asked to rate the importance of candidate items. An a priori threshold for inclusion was set at 80 per cent. The modified Delphi process culminated in a consensus meeting to develop the first iteration of the tool. In the final stage, two international patient workshops were held to assess the content validity and acceptability of the POST tool. RESULTS: The systematic review and scoping survey generated 64 symptoms, refined to 20 for inclusion in the modified Delphi consensus process. Twenty-six global experts participated in the Delphi consensus process. Five symptoms reached consensus across two rounds: difficulty getting solid foods down, chest pain after meals, difficulty getting liquids down, shortness of breath only after meals, and an early feeling of fullness after eating. The subsequent patient workshops deemed these five symptoms to be relevant and suggested that reflux should be included; these were taken forward to create the final POST tool. CONCLUSION: The POST tool is the first instrument designed to capture POH-specific symptoms. It will allow clinicians to standardize reporting of symptoms of POH and evaluate the response to surgical intervention.

Definitions and treatment of oligometastatic oesophagogastric cancer according to multidisciplinary tumour boards in Europe.

BACKGROUND: Consensus about the definition and treatment of oligometastatic oesophagogastric cancer is lacking. OBJECTIVE: To assess the definition and treatment of oligometastatic oesophagogastric cancer across multidisciplinary tumour boards (MDTs) in Europe. MATERIAL AND METHODS: European expert centers (n = 49) were requested to discuss 15 real-life cases in their MDT with at least a medical, surgical, and radiation oncologist present. The cases varied in terms of location and number of metastases, histology, timing of detection (i.e. synchronous versus metachronous), primary tumour treatment status, and response to systemic therapy. The primary outcome was the agreement in the definition of oligometastatic disease at diagnosis and after systemic therapy. The secondary outcome was the agreement in treatment strategies. Treatment strategies for oligometastatic disease were categorised into upfront local treatment (i.e. metastasectomy or stereotactic radiotherapy), systemic therapy followed by restaging to consider local treatment or systemic therapy alone. The agreement across MDTs was scored to be either absent/poor (<50%), fair (50%-75%), or consensus (≥75%). RESULTS: A total of 47 MDTs across 16 countries fully discussed the cases (96%). Oligometastatic disease was considered in patients with 1-2 metastases in either the liver, lung, retroperitoneal lymph nodes, adrenal gland, soft tissue or bone (consensus). At follow-up, oligometastatic disease was considered after a median of 18 weeks of systemic therapy when no progression or progression in size only of the oligometastatic lesion(s) was seen (consensus). If at restaging after a median of 18 weeks of systemic therapy the number of lesions progressed, this was not considered as oligometastatic disease (fair agreement). There was no consensus on treatment strategies for oligometastatic disease. CONCLUSION: A broad consensus on definitions of oligometastatic oesophagogastric cancer was found among MDTs of oesophagogastric cancer expert centres in Europe. However, high practice variability in treatment strategies exists.

Preoperative neutrophil-to-lymphocyte ratio behaves as an independent prognostic factor even in patients with postoperative complications after curative resection for gastric cancer.

PURPOSE: The aim of this study was to determine if the prognostic value of the preoperative neutrophil-to-lymphocyte ratio (NLR) could be modified by the presence of postoperative complications (POC) and their severity in patients with gastric adenocarcinoma resected with curative intent. METHODS: A retrospective study based on a prospective database of patients with resectable gastric adenocarcinoma treated with radical intention (R0) between January 1998 and February 2012. The primary endpoint was overall survival according to preoperative peripheral blood NLR and postoperative complications. Clinicopathological variables, preoperative blood tests, POC and its severity (Clavien-Dindo classification), type of POC (infectious or not infectious) and mortality were registered. A univariate and multivariate analysis (step forward Cox regression) was performed. The Kaplan-Meier method was used to assess overall survival. RESULTS: The 147 patients with gastric cancer who had undergone radical resection were included from an initial cohort of 209 patients. Univariant analysis: type of surgery, pT, pN, postoperative complications (Clavien-Dindo ≥ 3) and preoperative NLR ≥ 2.4 were significantly associated with survival (p < 0.05). Patients with POC showed worse long-term survival (p = 0.000), with no difference (p = 0.867) between infectious or non-infectious POC. NLR ≥ 2.4 was associated with infectious POC (p < 0.001). Patients with preoperative NLR ≥ 2.4 (p = 0.02) had a worse prognosis. Multivariate analysis: pN (p < 0.001), postoperative complications (p < 0.001) (HR 3.04; 95% CI: 1.97-4.70) and NLR ≥ 2.4 (p = 0.04) (HR = 1.55; 95% CI: 1.02-2.3) were independent prognostic factors. CONCLUSION: The preoperative inflammatory state of patients with gastric cancer measured by NLR behaves as an independent prognostic factor, even in patients with POC.

Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials.

OBJECTIVE: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts. SUMMARY OF BACKGROUND DATA: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence. METHODS: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory. RESULTS: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700. CONCLUSIONS: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials. ETHICAL APPROVAL: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621.