Short-term postoperative outcomes of gastric adenocarcinoma patients treated with curative intent in low-volume centers.

BACKGROUND: Quality standards in postoperative outcomes have not yet been defined for gastric cancer surgery. Also, the effect of centralization of gastric cancer surgery on the improvement of postoperative outcomes continues to be debated. Short-term postoperative outcomes in gastric carcinoma patients in centers with low-volume of annual gastrectomies were assessed. The effect of age on major postoperative morbidity and mortality was also analyzed. METHODS: Patients with gastric or gastroesophageal junction Siewert III type carcinomas who underwent surgical treatment with curative intent between January 2013 and December 2016 were included. Data were obtained from the population-based surgical registry Esophagogastric Carcinoma Registry of the Comunitat Valenciana (RECEG-CV). The RECEG-CV gathers information on demographic characteristics and comorbidity, preoperative study and neoadjuvant treatment, surgical procedure, pathological study, postoperative outcomes, and follow-up. Seventeen hospitals belonging to the public network participated in this registry. RESULTS: Data from 591 patients were analyzed. Postoperative major morbidity occurred in 154 (26.1%) patients. Overall 30-day or in-hospital mortality, and 90-day postoperative mortality rates were 8.6% and 10.1% respectively. Failure-to-rescue was 39% and it was significantly higher in patients aged 75 years or older in comparison with younger patients (55.3% vs 23.1% p < 0.001). In the multivariable analysis, age ≥ 75 years (p = 0.029), laparoscopic approach (p = 0.005), and total gastrectomy (p = 0.005) were associated with major postoperative morbidity. Age ≥ 75 years (p = 0.027), pulmonary complications (p = 0.001), cardiac complications (p = 0.001), leakage (p = 0.003), and hemorrhage (p = 0.013) were associated with postoperative mortality. CONCLUSIONS: Centralization of gastric adenocarcinoma treatment in centers with higher annual caseload should be considered to improve the short-term postoperative outcomes in low-volume centers. Patients aged 75 or older had a significantly increased risk of major postoperative morbidity and mortality, and higher failure-to-rescue.

Outcome quality standards for surgery of colorectal liver metastasis.

PURPOSE: Liver metastases are the most common malignant solid liver lesions, approximately 40% of which stem from colorectal tumors. Liver resection is currently the only curative treatment for colorectal cancer liver metastases (CRLM). However, there is a lack of consensus criteria to assess the results of this treatment. In order to evaluate the quality of surgical outcomes, it is necessary to identify quality indicators (QIs) and their corresponding quality standards (QS). We propose a simple method to determine QI and QS in CRLM surgery (CRLMS) and establish acceptable quality limits (AQL) for each QI. MATERIAL AND METHODS: A systematic review of CRLMS results published from 2006 to 2016. Clinical guidelines, consensus conferences, and publications related to the CRLMS were reviewed to identify and select QIs. Once selected, a new review of the papers including the results of at least one of the QIs was performed. Statistical process control (SPC) method was applied to calculate the QS and AQL of each QI. The limits of variability were established from mean and confidence intervals at 95% and 99.8%. RESULTS: The most relevant QIs and its AQLs were postoperative mortality (2%, < 4.5%), overall postoperative morbidity (33%, < 41%), liver failure (5%, < 8%), postoperative hemorrhage (1%, < 3%), biliary fistula (6%, < 10%), reoperation (3%, < 6%), R1 resection margins (18%, < 25%), and overall survival at 12 and 60 months (84%, > 77%; and 34%, > 25%, respectively). CONCLUSIONS: Despite its limitations, the present study constitutes the most extensive scientific evidence to date on QI and AQL in CRLMS and may constitute a reference in future studies.

Idiopathic granulomatous mastitis: A systematic review of 3060 patients.

Idiopathic granulomatous mastitis is a rare benign breast disease. A systematic review was designed. Clinical and therapeutic characteristics were analyzed. Human Development Index (HDI) was used to define two groups of study: group A (very high and high HDI) and group B (medium and low HDI). Corticosteroid therapy was done in 69% group A and 78% group B. Surgery was done in 63% in group A and 83% in group B. Antibiotics were used in 68% group A and 88% group B. There is no consensus about optimal treatment for granulomatous mastitis.

The lymph node status as a prognostic factor in colon cancer: comparative population study of classifications using the logarithm of the ratio between metastatic and nonmetastatic nodes (LODDS) versus the pN-TNM classification and ganglion ratio systems.

BACKGROUND: pN stage in the TNM classification has been the "gold standard" for lymph node staging of colorectal carcinomas, but this system recommends collecting at least 12 lymph nodes for the staging to be reliable. However, new prognostic staging systems have been devised, such as the ganglion quotients or lymph node ratios and natural logarithms of the lymph node odds methods. The aim of this study was to establish and validate the predictive and prognostic ability of the lymph node ratios and natural logarithms of the lymph node odds staging systems and to compare them to the pN nodal classification of the TNM system in a population sample of patients with colon cancer. METHODS: A multicentric population study between January 2004 and December 2007. The inclusion criteria were that the patients were: diagnosed with colon cancer, undergoing surgery with curative intent, and had a complete anatomopathological report. We excluded patients with cancer of the rectum or caecal appendix with metastases at diagnosis. Survival analysis was performed using the Kaplan-Meier actuarial method and the Log-Rank test was implemented to estimate the differences between groups in terms of overall survival and disease-free survival. Multivariate survival analysis was performed using Cox regression. RESULTS: We analysed 548 patients. For the overall survival, the lymph node ratios and natural logarithms of the lymph node odds curves were easier to discriminate because their separation was clearer and more balanced. For disease-free survival, the discrimination between the pN0 and pN1 groups was poor, but this phenomenon was adequately corrected for the lymph node ratios and natural logarithms of the lymph node odds curves which could be sufficiently discriminated to be able to estimate the survival prognosis. CONCLUSIONS: Lymph node ratios and natural logarithms of the lymph node odds techniques can more precisely differentiate risk subgroups from within the pN groups. Of the three methods tested in this study, the natural logarithms of the lymph node odds was the most accurate for staging non-metastatic colon cancer. Thus helping to more precisely adjust and individualise the indication for adjuvant treatments in these patients.

CUSUM charts in the quality control of colon cancer lymph node analysis: a population-registry study.

BACKGROUND: The most important determinant of survival in patients with colon cancer is the presence or absence of regional lymph node metastases. This factor is consistently associated with long-term and disease-specific survival. Cumulative summation of differences (CUSUM) charts can help to discriminate abnormalities that cannot be explained by the general variability of a process. We used CUSUM charts to analyse the quality of nodal analysis in colon cancer and to use a population-registry cancer database to estimate the optimal number of lymph nodes for adequate prognostic analysis. METHODS: This was a multicentre population-registry cancer study from January 2004 to December 2007. We used these data to produce the different CUSUM curves, focusing on the main variables. To calculate survival, we used the Kaplan-Meier method. RESULTS: In this study, we examined 548 patients. The CUSUM curves were calculated for overall mortality, specific mortality, and recurrence according to (1) the number of lymph nodes analysed and affected and (2) compared the ratio of the number of lymph nodes affected to the number analysed. Finally, the lymph node ratio was compared to the overall survival CUSUM curve. DISCUSSION: This CUSUM control chart analysis reinforces the unquestionable importance of analysing at least 12 lymph nodes in patients with colon cancer in order to accurately estimate their prognosis. However, our findings indicate that the analysis of at least 20 lymph nodes is a more appropriate cutoff point for accomplishing the demanding objective of diagnosing a high-quality prognosis in colon cancer patients.

Outcome quality standards in pancreatic oncologic surgery.

PURPOSE: To identify quality indicators and establish acceptable quality limits (AQLs) in pancreatic oncologic surgery using a formal statistical methodology. METHODS: Indicators have been identified through systematic literature reviews and guidelines for pancreatic surgery. AQLs were determined for each indicator with confidence intervals of 99.8 and 95 % above and below the weighted average by sample size from the different series examined. RESULTS: Several indicators have been identified with the following results as AQLs: resectability rate >59 %; morbidity, mortality, and pancreatic fistula rate in pancreaticoduodenectomy <55, <5, and <16 %, respectively; morbidity, mortality, and fistula rate in distal pancreatectomy <53, <4, and <31 %, respectively; number of lymph nodes retrieved >15; R1 resection <46 %; survival at 1, 3, and 5 years >54, >19, and >8 %, respectively. CONCLUSIONS: A series of different indicators for quality surgical care outcome in pancreatic cancer, as well as their limits, have been determined according to a standard methodology.

[Diagnostic yield of pancreatic percutaneous puncture depending on the size of the lesion]. / Rentabilidad diagnóstica de la punción percutánea pancreática en función del tamaño de la lesión.

INTRODUCTION: The aim of the present study was to study the diagnostic efficacy of the percutaneous puncture of pancreatic tissue. MATERIAL AND METHODS: A retrospective study was conducted on patients with suspicion of pancreatic neoplasm, and with a percutaneous biopsy of pancreatic tissue, from 2000 to 2011. For the statistical comparative analysis, the sample was stratified by tumour size: ≤ 3cm and > 3cm. RESULTS: A total of 90 biopsies were performed. Pancreatic neoplasm diagnosis was made in 47 cases (52%), with 16 false negatives (18%), no false positives, and chronic pancreatitis in 24 cases (27%). The efficacy of the test results were: an overall sensitivity of 75% (95% CI: 62%-85%), a specificity of 100% (95% CI: 87%-100%), a positive predictive value of 100% (95% CI: 92%-100%), and a negative predictive value of 63% (95% CI: 46%-77%). For tumour sizes ≤ 3cm the sensitivity was 70% (95% CI: 45%-88%), with a specificity of 100% (95% CI 66%-100%), a positive predictive value of 100% (95% CI: 76%-100%, and a negative predictive value 60% (95% CI: 32%-83%). For tumours greater than 3cm, the sensitivity was 88% (95% CI: 70%-98%), the specificity was 100% (95% CI: 75%-100%), with a positive predictive value of 100% (95% CI: 85%-100%) and a negative predictive value of 81% (95% CI: 54%-96%). CONCLUSIONS: Pancreatic percutaneous biopsy efficacy was strongly determined by lesion size. For tumour sizes less than 3cm, the sensitivity and negative predictive value are unacceptably low, as negative results would not reliable.

[Preoperative weight loss in bariatric surgery candidate patients. evidence-based recommendations]. / Pérdida de peso preoperatoria en pacientes candidatos a cirugía bariátrica. Recomendaciones basadas en la evidencia.

INTRODUCTION: Bariatric surgery is becoming increasingly more common in the treatment of morbid obesity in our hospitals. One of the measures being used to optimise the results of this surgery seems to be the standardising the preoperative weight loss. As there are no universal recommendations for carrying out this weight loss, a review of this topic is presented. OBJECTIVES: To analyse whether sufficient scientific evidence exists to recommend preoperative weight loss in candidate patients for bariatric surgery. What would be the best options to carry out this weight loss is also analysed, as well as making some recommendations based on the scientific evidence. RESULTS: There is great heterogeneity in the designs of the different studies, with different guidelines for weight loss and various surgical techniques. However, preoperative weight loss leads to a decrease in the size of the liver and intra-abdominal fat, which improves the surgical field and intra-operative view, which in turn helps during the surgical act, both in open as well as laparoscopic surgery. There is no consensus on the effect of preoperative weight loss has in predicting the medium or long term results after bariatric surgery. CONCLUSION: The current scientific evidence makes preoperative weight loss recommendable in candidate patients for bariatric surgery. However, there is no consensus on what is the best procedure to achieve this preoperative weight loss.

Effect of Preoperative Immunonutrition on Postoperative Major Morbidity after Cytoreductive Surgery and HIPEC in Patients with Peritoneal Metastasis.

The effect of preoperative immunonutrition intake on postoperative major complications in patients following cytoreductive surgery (CRS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC) was assessed. The accuracy of C-Reactive Protein (CRP) for detecting postoperative complications was also analyzed. Patients treated within a peritoneal carcinomatosis program in which a complete or optimal cytoreduction was achieved were retrospectively analyzed. They were divided into two groups based on whether preoperative immunonutrition (IMN) or not (non-IMN) were administered. Clinical and surgical variables and postoperative complications were gathered. Predictive values of major morbidity of CRP during the first 3 postoperative days (POD) were also evaluated. A total of 107 patients were included, 48 belonging to the IMN group and 59 to the non-IMN group. In multivariate analysis immunonutrition (OR 0.247; 95%CI 0.071-0.859; p = 0.028), and the number of visceral resections (OR 1.947; 95%CI 1.086-3.488; p = 0.025) emerged as independent factors associated with postoperative major morbidity. CRP values above 103 mg/L yielded a negative predictive value of 84%. Preoperative intake of immunonutrition was associated with a decrease of postoperative major morbidity and might be recommended to patients with peritoneal carcinomatosis following CRS. Measuring CRP levels during the 3 first postoperative days is useful to rule out major morbidity.

Non-arbitrary minimum threshold of yearly performed pancreatoduodenectomies: National multicentric study.

BACKGROUND: Annual hospital volume of pancreatoduodenectomies could influence postoperative outcomes. The aim of this study is to establish with a non-arbitrary method the minimum threshold of yearly performed pancreatoduodenectomies in order to improve several postoperative quality outcomes. METHOD: Prospective follow-up of patients submitted to pancreatoduodenectomy in participating hospitals during 1 year. The influence of hospital volume on quality outcomes was analyzed by univariable and multivariable models. The minimum threshold of yearly performed pancreatoduodenectomies to improve outcomes was established by Akaike's information criteria. RESULTS: Data from 877 patients operated in 74 hospitals were analyzed. Of 12 quality outcomes, 9 were influenced by hospital pancreatoduodenectomy volume on multivariable analysis. To decrease the risk of complications and the risk of retrieving an insufficient number of lymph nodes at least 31 pancreatoduodenectomies per year should be performed. To decrease the risk of prolonged length of stay, postoperative death, and affected surgical margins, at least 37, 6, and 14 pancreatoduodenectomies per year should be performed, respectively. CONCLUSION: Several postoperative quality outcomes are influenced by the number of yearly performed pancreatoduodenectomies and could be improved by establishing a minimum threshold of procedures. Number of procedures needed to improve quality outcomes has been established by a non-arbitrary method.

[A method for individualising the risk of a negative lymph node classification error in cancer of the colon]. / Un método para individualizar el riesgo de una errónea clasificación ganglionar negativa en el cáncer de colon.

INTRODUCTION: In cancer of the colon, the number of lymph nodes that should be analysed before a patient is classified as free of lymph node involvement has been widely discussed. A mathematical model is proposed which is based on the Bayes Theorem for calculating the probability of error (PE) similar to that normally used to evaluate a diagnostic test, but adapted to a quantitative variable, the lymph node count. METHODS: The clinical histories of 480 patients routinely operated on in attempt to cure cancer of the colon were reviewed. Cases with any kind of metastasis were excluded. The proposed formula based on the Bayes Theorem was applied with the aim of calculating the PEs for the complete series and for different patient sub-groups (T2, T3, and T4 tumours). RESULTS: For the probabilities of error of classifying a patient as N negative, which varied between 5% and 1% (near or practically 0), the minimum number of negative lymph nodes required for analysis fluctuated between 7 and 17, respectively, for the complete series. This minimum figure was also variable for the different sub-groups (T2, T3, and T4 tumours) studied. These numbers mainly depended on the case characteristics of a specific study group as regards the prevalence of the N+ cases that they dealt with, and of its historically demonstrated ability to collect and identify positive lymph nodes in those patients that had them. CONCLUSION: From a mathematical point of view, the minimum number of lymph nodes that have to be analysed in cancer of the colon in order to classify a patient as N negative is not a constant. This depends on the error that is prepared to be assumed for that diagnosis, possibly depending on certain tumour traits, and also may be adapted to the cases of each study group.

Disease-free survival and prognostic significance of metastatic lymph node ratio in T1-T2 N positive breast cancer patients. A population registry-based study in a European country.

BACKGROUND: The ratio of positive lymph nodes between the total number of harvested lymph nodes (metastatic lymph node ratio, MLNR) has been proposed as an alternative to the total number of lymph nodes alone in predicting outcomes for patients with breast cancer. Because there can be differences between European and non-European populations, the authors present the first study analyzing MLNR influence over disease-free survival (DFS) by using a population-based cancer registry in a European country. METHODS: Data from 441 patients with T1-2 N1-3 breast cancer included in the Castellon Cancer Registry (Comunidad Valenciana, Spain) were used. Cumulative DFS was determined using the Kaplan-Meier method, with univariate comparisons between groups through the log-rank test. The Cox proportional hazards model was used for multivariate analysis. RESULTS: At univariate analysis, factors influencing the 10-year DFS rate were tumor size, conservative or nonconservative surgery, histologic grade, histologic type, radiotherapy, tamoxifen, estrogen and progesterone receptor status, p53 status, total number of positive lymph nodes, and MLNR. At multivariate analysis, tumor size, MLNR, and progesterone receptor status were revealed to be independent prognostic factors; the metastatic lymph node ratio was the most notably independent factor (hazard ratio 1.02, 5.21, and 0.61, respectively). CONCLUSIONS: MLNR is a stronger prognostic factor for recurrence than the total number of positive lymph nodes in T1-T2 N1-3 breast cancer.

Quality control techniques in surgery: Application of cumulative sum (CUSUM) charts. / Técnicas de control de calidad en cirugía. Aplicación de las gráficas de control cumulative sum.

Cumulative sum graphs are quality control charts that are possibly the most frequently used for monitoring clinical-care processes. One of their main advantages is the use in rare cases and in events with low incidence, where it would be necessary to obtain a large sample and a long follow-up time with conventional statistical methods, which is impossible in certain cases. This is also why they are useful for studying learning curves, the introduction of new technologies and, in general, for assessing the quality of care outcomes themselves, because their profile is sensitive to very subtle changes in trends (positive or negative), which would not be observed with other methods. On the other hand, their use can be expanded beyond quality control or monitoring, which is a new aspect in clinical research.

Modelling the probability of erroneous negative lymph node staging in patients with colon cancer.

BACKGROUND: Patients in who with insufficient number of analysed lymph nodes (LNs) are more likely to receive an incorrect LN staging. The ability to calculate the overall probability of undiagnosed LN involvement errors in these patients could be very useful for approximating the real patient prognosis and for giving possible indications for adjuvant treatments. The objective of this work was to establish the predictive capacity and prognostic discriminative ability of the final error probability (FEP) among patients with colon cancer and with a potentially incorrectly-staged LN-negative disease. METHODS: This was a retrospective multicentric population study carried out between January 2004 and December 2007. We used a mathematical model based on Bayes' theorem to calculate the probability of LN involvement given a FEP test result. Cumulative sum graphs were used to calculate risk groups and the survival rates were calculated, by month, using the Kaplan-Meier method. RESULTS: A total of 548 patients were analysed and classified into three risk groups according to their FEP score: low-risk (FEP < 2%), intermediate-risk (FEP 2%-15%), and high-risk (FEP > 15%). Patients with LN involvement had the lowest overall survival rate when compared to the three risk groups. This difference was statistically significant for the low- and intermediate-risk groups (P = 0.002 and P = 0.004, respectively), but high-risk group presented similar survival curves to pN+ group (P = 0.505). In terms of disease-free survival, the high-risk group presented similar curves to the intermediate-risk group until approximately 60 months' follow-up (P = 0.906). After 80 months' follow-up, the curve of high-risk group coincided with that of the pN+ group (P = 0.172). Finally, we summarized the FEP according to the number of analysed LNs and accompanied by a contour plot which represents its calculation graphically. CONCLUSIONS: The application of Bayes' theorem in the calculation of FEP is useful to delimit risk subgroups from among patients without LN involvement.

Clinical Relevance of a Balance Training Program on Liver Transplant Patients. A Randomized Controlled Trial.

BACKGROUND: Although some studies have reported significant improvements in physical function and strength after training programs on liver transplant (LT) recipients, there is a lack of knowledge on how it affects in static and dynamic balance, being an important part of these participants' tasks development. The aim of the study was to determine the effects of a 6-month multicomponent circuit training program on static and dynamic balance in LT participants. METHODS: Fifty-four participants were randomized at 6 months after LT into 2 groups: exercise (EXER) group and control (CONTROL) group, with repeat testing at 6 (baseline) and 12 months after LT. The intervention consisted of a multicomponent training, including balance, strength, endurance, and flexibility training, with exercises arranged in a circuit setup and a moderate intensity with high perceived exertion. Training sessions were performed in the hospital facilities with qualified trainers. To determine differences over time between EXER and CONTROL, mixed-regression linear models with subject variable as random factor and variables of treatment duration, type, and interaction as predictors were used. RESULTS: The EXER group showed significant differences (P < 0.05) compared with CONTROL in all variables of static and dynamic balance, hip strength (49% versus 13%), agility (-16% versus -1%), and flexibility (78% versus -26%). Adherence to the intervention was 94%, and 80% of the participants continued voluntarily training after the 6 months. CONCLUSIONS: This study demonstrated that a multicomponent circuit training program at a moderate intensity with high perceived exertion could reduce the probability of injuries because it improves balance on LT recipients.

The 8th edition of the AJCC-TNM classification: New contributions to the staging of esophagogastric junction cancer. / La 8.ª edición de la clasificación AJCC-TNM: nuevas aportaciones a la estadificación del cáncer de la unión esofagogástrica.

The new 8th edition of the TNM classification system for esophageal and cardia or esophagogastric junction cancer provides important innovations in the TNM stages. Two classifications are presented, updated by stages, clinical (cTNM) and pathological (pTNM) methods, together with another pathological classification applicable to cases receiving neoadjuvant treatment (ypTNM). There is a notable increase in complexity compared to previous versions, but it is still early to determine whether the current modifications will result in a clear improvement in the prognostic discrimination of survival among the patient groups (which is their main objective), although the initial expectations are favorable.

New technologies in cancer and their assessment. The clinical surgeon's point of view.

The assessment of new technologies in oncological surgery is an important part of clinical research in cancer. The special characteristics of surgeons and surgical techniques determine particular problems. In this review, from the perspective of efficacy, effectiveness and efficiency, problematic specific aspects are discussed for diagnostic and therapeutic technologies.

[Recommendations for the clinical evaluation of results in the biomedical literature]. / Recomendaciones para la valoración clínica de los resultados en literatura biomédica.

The assessment and interpretation of the results of a clinical study are a real challenge for the clinicians. In this paper we establish a general basis for a critical and reserved assessment of these, from the fundamental aspects of the design and statistics, as well as the application of the results to our own patients according to risk and benefit criteria. Main errors and the traps that should be avoided are emphasised.