[Show abstract][Hide abstract] ABSTRACT: Aims:
The aims of this study were to compare short- and long-term outcomes for clinical T2N0 oesophageal cancer with analysis of (i) primary surgery (S) versus neoadjuvant therapy plus surgery (NS), (ii) squamous cell carcinoma and adenocarcinoma subsets; and (iii) neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy.
Data were collected from 30 European centres from 2000 to 2010. Among 2944 included patients, 355 patients (12.1%) had cT2N0 disease; 285 (S) and 70 (NS), were compared in terms of short- and long-term outcomes. Propensity score matching analyses were used to compensate for differences in baseline characteristics.
No significant differences between the groups were shown in terms of in hospital morbidity and mortality. Nodal disease was observed in 50% of S-group at the time of surgery, with 20% pN2/N3. Utilisation of neoadjuvant therapy was associated with significant tumour downstaging as reflected by increases in pT0, pN0 and pTNM stage 0 disease, this effect was further enhanced with neoadjuvant chemoradiotherapy. After adjustment on propensity score and confounding factors, for all patients and subset analysis of squamous cell and adenocarcinoma, neoadjuvant therapy had no significant effect upon survival or recurrence (overall, loco-regional, distant or mixed) compared to surgery alone. There were no significant differences between neoadjuvant chemotherapy and chemoradiotherapy in short- or long-term outcomes.
The results of this study suggest that a surgery alone treatment approach should be recommended as the primary treatment approach for cT2N0 oesophageal cancer despite 50% of patients having nodal disease at the time of surgery.
Full-text · Article · Mar 2016 · European journal of cancer (Oxford, England: 1990)
[Show abstract][Hide abstract] ABSTRACT: Objectives:
To evaluate prospectively the performance of diffusion-weighted imaging (DWI) for detection of active lesions on MR-enterography (MRE) in children with inflammatory bowel disease (IBD).
Material and methods:
MRE of 48 children (mean age 13 years) with suspected or known IBD were blindly analyzed by two independent readers for the presence of active lesions. Two sets of imaging including DWI and gadolinium-enhanced imaging (GEI) were reviewed. A reader consensus was obtained. Gold standard was histopathological findings. In patient-level analysis and segment-level analysis, sensitivity and specificity were calculated for DWI and GEI, and compared using McNemar's test or logistic random-effects models.
At least one active lesion was confirmed in 42 children (87.5%). Sensitivity and specificity for detection of at least one lesion were respectively 88.1% (95%CI, 74.3-96.1), 83.3% (95%CI, 35.9-99.6) for DWI and 66.7% (95%CI, 50.4-80.4), 83.3% (95%CI, 35.9-99.6) for GEI. In segment-level analysis, sensitivity and specificity for detection of specific-segment lesions were respectively 62.5% (95%CI,48.1-75) and 97.1% (95%CI,93.5-98.7) for DWI and 45.7% (95%CI,30.8-61.3) and 98.2% (95%CI,95.3-99.4) for GEI. Sensitivity of DWI was significantly better than GEI per patient (p=0.004) and per segment (p=0.028).
DWI demonstrates better performance than GEI for detection of active lesions in children with IBD. Advances in knowledge: Examination with no intravenous injection. DWI can replace T1weighted-images when pediatric patients are screened with MRE for IBD. Examination performed in free-breathing is better tolerated by children.
No preview · Article · Feb 2016 · The British journal of radiology
[Show abstract][Hide abstract] ABSTRACT: Objective:
To determine whether the different antimüllerian hormone (AMH) immunoassays on the market offer the same performance for the diagnosis of polycystic ovary syndrome (PCOS).
A total of 95 serum AMH samples were retrospectively evaluated for a period of 3 months in the same laboratory.
Academic center laboratory.
Forty-eight control women with regular menses and no hyperandrogenism and 47 patients with classic PCOS (i.e., hyperandrogenism plus oligoanovulation) attending our department for infertility.
Main outcome measure(s):
AMH measurement using five commercial assays. Method comparison and evaluation of the diagnostic performance by receiver operating characteristic analysis.
Values obtained with Gen II and AL-105i ELISAs were similar to those provided by EAI AMH/MIS, whereas automatic assays generated lower values. A significant mean difference was observed between Access Dxi (1.35 ng/mL) or Cobas (1.73 ng/mL) and EIA AMH/MIS ELISA. By ROC analysis each assay displayed similar efficiency for PCOS diagnosis. Sensitivities varied from 49% to 74% when setting the specificity at 92%. Cluster analysis run in the control group identified a subgroup of asymptomatic women with polycystic ovary morphology (PCOM). After exclusion of PCOM, the 95th percentile of controls was 4.2 ng/mL (30 pmol/L) with the automatic assays and 5.6 ng/mL (40 pmol/L) with the manual assays.
Performance of the different AMH assays for PCOS diagnosis is comparable, providing that different threshold values are used for manual and automatic assays. Measurement of serum AMH level appears as a robust tool for the definition of PCOM.
No preview · Article · Jan 2016 · Fertility and sterility
[Show abstract][Hide abstract] ABSTRACT: Underinflation of tracheal cuff is a risk factor for microaspiration of contaminated secretions and subsequent ventilator-associated pneumonia (VAP). The aim of this collaborative meta-analysis of individual participant data is to determine the impact of continuous control of P cuff on the incidence of VAP.
Studies were identified by searching PubMed and references of relevant articles. Data from 3 prospective controlled trials (two randomized and one quasi-randomized), which evaluated the impact of continuous control of P cuff on the incidence of VAP, were obtained and pooled together. Three different devices were used to continuously control P cuff . VAP was diagnosed using clinical, radiologic, and quantitative microbiological criteria. The impact of continuous control of P cuff on VAP was assessed by Cox regression analysis, stratified on trial.
263 (48.4 %) patients received continuous control of P cuff , and 280 (51.5 %) patients received routine control of P cuff using a manometer. 36 (13.6 %) VAP were diagnosed in continuous control group, and 72 (25.7 %) in routine care group (HR 0.47, 95 % CI 0.31–0.71, p < 0.001). However, heterogeneity was apparent in continuous control effect size across trials (I 2 = 58 %, p = 0.085). The number of patients needed to treat to prevent one VAP episode was 8. No significant impact of continuous control of P cuff was found on duration of mechanical ventilation, ICU length of stay, or mortality.
Continuous control of P cuff might be beneficial in reducing the risk for VAP. However, no significant impact of continuous control of P cuff was found on duration of mechanical ventilation, ICU length of stay, or mortality.
Full-text · Article · Dec 2015 · Annals of Intensive Care
[Show abstract][Hide abstract] ABSTRACT: Background
The prognosis and chemoresistance of signet-ring cell (SRC) gastric adenocarcinoma have been reported and debated, and the utility of perioperative chemotherapy for such a tumor has been questioned
. This study was performed to assess the impact of the SRC type on survival following resection of gastric adenocarcinoma, and to assess whether the prognostic factors (including perioperative chemotherapy) for non-SRC adenocarcinoma differed from those for SRC adenocarcinoma.
1799 cases of adenocarcinoma that were consecutively treated from 1997 to 2010 in 19 French centers by subtotal or total gastrectomy were included in a retrospective study. A D2 lymphadenectomy was performed for antropyloric tumors, and a modified D2 for upper tumors. SRC adenocarcinoma was diagnosed based on the presence of isolated carcinoma cells containing mucin.
A total gastrectomy was performed in 979 (54.4 %) patients. SRC adenocarcinoma was diagnosed in 899 (50 %) patients. Patients with an SRC tumor were more frequently female, younger, and malnourished, had lower ASA scores, and had larger tumors than non-SRC patients. Median survival in patients with non-SRC carcinoma was 51 months, as compared to 26 months in patients with SRC carcinoma (p < 0.001). At multivariate analysis, SRC type remained an independent adverse prognostic factor (HR = 1.182). Factors that were prognostic in the SRC subgroup but not in the non-SRC subgroup were age >60 years, linitis, and involvement of adjacent organs. In contrast to non-SRC tumors, pre- and postoperative chemotherapy did not significantly impact on survival following resection of SRC adenocarcinoma.
In comparison to non-SRC adenocarcinoma, the SRC type has a worse prognosis, different prognostic factors, and is only poorly sensitive to perioperative chemotherapy. Non-SRC and SRC adenocarcinomas should be considered different entities in future therapeutic trials.
[Show abstract][Hide abstract] ABSTRACT: Leukemia is one of the leading journals in hematology and oncology. It is published monthly and covers all aspects of the research and treatment of leukemia and allied diseases. Studies of normal hemopoiesis are covered because of their comparative relevance.
No preview · Article · Nov 2015 · Leukemia: official journal of the Leukemia Society of America, Leukemia Research Fund, U.K
[Show abstract][Hide abstract] ABSTRACT: The present study sought to characterize and predict the recognition of emotional stimuli (presented in a visual or auditory modality) by patients with temporal lobe epilepsy (TLE).
Fifty TLE patients and 50 matched controls performed two emotion recognition tasks (emotional faces and emotional bursts). Neutral stimuli were also presented, and emotional biases were monitored by analyzing errors. Demographic, cognitive, psychobehavioral and (in TLE patients only) clinical and quality of life data were also recorded.
Compared with controls, TLE patients were impaired in the recognition of fear expressions in both visual and auditory modality tasks. However, impairments in the two channels were not always concomitant on the individual level. In the visual modality, recognition of disgust and neutral expressions was significantly worse in TLE patients. In the auditory modality, nonsignificant trends toward poor recognition of disgust and neutral expressions were observed. Negative biases were noted in TLE patients; expressions of fear (faces and bursts) were more frequently misinterpreted as disgust, and neutral facial expressions were more frequently misinterpreted as sadness. Impairments in the recognition of facial fear were less pronounced in left TLE patients who (according to structural magnetic resonance imaging, MRI) did not have any brain lesions. In TLE patients, low levels of social support (a quality of life parameter) were associated with worse recognition of facial disgust, and higher levels of apathy were associated with better recognition of neutral faces.
TLE patients are impaired in some aspects of emotion recognition with both visual and auditory stimuli, although the differential impact of TLE on these modalities requires further research. These emotional impairments are related to quality of life and psychobehavioral parameters.
No preview · Article · Nov 2015 · Journal of Clinical and Experimental Neuropsychology
[Show abstract][Hide abstract] ABSTRACT: Objectives: The aim of the study was to compare the postoperative and oncologic outcomes of laparoscopic versus open surgery for gastric gastrointestinal stromal tumors (gGISTs). Background: The feasibility of the laparoscopic approach for gGIST resection has been demonstrated; however, its impact on outcomes, particularly its oncologic safety for tumors greater than 5 cm, remains unknown. Methods: Among 1413 patients treated for a GIST in 61 European centers between 2001 and 2013, patients who underwent primary resection for a gGIST smaller than 20 cm (N = 666), by either laparoscopy (group L, n = 282) or open surgery (group O, n = 384), were compared. Multivariable analyses and propensity score matching were used to compensate for differences in baseline characteristics. Results: In-hospital mortality and morbidity rates in groups L and O were 0.4% versus 2.1% (P = 0.086) and 11.3% vs 19.5% (P = 0.004), respectively. Laparoscopic resection was independently protective against in-hospital morbidity (odds ratio 0.54, P = 0.014). The rate of R0 resection was 95.7% in group L and 92.7% in group O (P = 0.103). After 1:1 propensity score matching (n = 224), the groups were comparable according to age, sex, tumor location and size, mitotic index, American Society of Anesthesiology score, and the extent of surgical resection. After adjustment for BMI, overall morbidity (10.3% vs 19.6%; P = 0.005), surgical morbidity (4.9% vs 9.8%; P = 0.048), and medical morbidity (6.2% vs 13.4%; P = 0.01) were significantly lower in group L. Five-year recurrence-free survival was significantly better in group L (91.7% vs 85.2%; P = 0.011). In tumors greater than 5 cm, in-hospital morbidity and 5-year recurrence-free survival were similar between the groups (P = 0.255 and P = 0.423, respectively). Conclusions: Laparoscopic resection for gGISTs is associated with favorable short-term outcomes without compromising oncologic results.
No preview · Article · Nov 2015 · Annals of Surgery
[Show abstract][Hide abstract] ABSTRACT: Objective:
The analysis of treatment effects in clinical trials usually focus on efficacy and safety in separate descriptive statistical analyses. The Q-TWiST (Quality adjusted Time Without Symptoms and Toxicity) method has been proposed by Gelber in the 90s to enable a statistical comparison between two groups with a graphical representation by incorporating benefit and risk into a single analysis. Although the method has been programmed in SAS, it is rarely used. The availability of the method in the freely software environment system like R would greatly enhanced the accessibility by researchers. The objective of this paper is to present a program for Q-TWiST analyses within R software environment.
The qtwist function was developed in order to estimate and compare Q-TWiST for two groups. Two individual patient data files are required used for input: one for visits and one for follow-up. Q-TWiST is obtained as a sum of time spent in three health states: period in toxicity (TOX), period without relapse and toxicity (TWiST) and period in relapse (REL), weighted by associated utility scores restricted to median overall survival for example. The bootstrap method is used for testing statistical significance. Threshold analysis and gain functions allow a group comparison for different utility values.
Input data is checked for consistency. Descriptive statistics and mean durations for each health state are provided, allowing statistical comparisons. Graphical results are presented in a PDF file. The use of the function is illustrated with data from a simulated data set and a randomized clinical trial.
qtwist is an easy to use R function, allowing a quality adjusted survival analysis with the Q-TWiST method.
No preview · Article · Nov 2015 · Computer methods and programs in biomedicine
[Show abstract][Hide abstract] ABSTRACT: Objective:
This study was designed to investigate the impact of laparoscopic gastric mobilization (LGM) on 30-day postoperative mortality (POM) after surgery for esophageal cancer (EC).
Meta-analyses of nonrandomized studies have failed to demonstrate any significant benefit of hybrid minimally invasive esophagectomy on POM, potentially due to small population samples. Moreover, none of the published randomized trials have been designed to answer this question.
All consecutive patients who underwent EC resection between 2010 and 2012 in France were included in this nationwide study (n = 3009). Data were extracted from the French National Health Service Database with internal and external quality controls. Patients treated with LGM (LGM group, n = 663) were compared with those treated with open approach (open group, n = 2346). Propensity score matching and multivariable analyses were used to compensate for the differences in baseline characteristics.
The 30-day POM rate was 5.2%, significantly lower after LGM, compared with open surgery (3.3% vs 5.7%, P = 0.005), as well as in-hospital (5.6% vs 8.1%, P = 0.028), and 90-day POM (6.9% vs 10.0%, P = 0.016). After propensity score matching, 30-day POM rates were 3.3% versus 5.9%, respectively (P = 0.029). By multivariable analysis, age ≥60 years, malnutrition and cardiovascular comorbidity were independently associated with higher POM, whereas LGM was associated with a decrease in POM (OR 0.60, 95% CI 0.37-0.98, P = 0.041).
This all-inclusive nationwide study strongly suggests that POM is significantly reduced after LGM for EC. This is high valuable evidence that helps decision making regarding the optimal approach for EC surgery.
No preview · Article · Nov 2015 · Annals of Surgery
[Show abstract][Hide abstract] ABSTRACT: Objective:
To assess the relationships among physical activity, measured objectively, and attention capacity in European adolescents.
The study included 273 adolescents, aged 12.5-17.5 years, who participated in the Healthy Lifestyle in Europe by Nutrition in Adolescence Study. Participants wore a uniaxial accelerometer for 7 days to measure physical activity. The d2 Test of Attention was administered to assess attention capacity. Multivariate analyses were used to study the association of attention capacity with each measure of physical activity. Receiver operating characteristic analysis was performed to determine thresholds that best discriminate between low and good attention capacity.
After controlling for potential confounding variables (age, sex, body mass index, parental educational level, fat mass, aerobic fitness, and center), adolescents' attention capacity test performances were significantly and positively associated with longer time spent in moderate or moderate-to-vigorous physical activity (MVPA) in free-living conditions (P < .05). Receiver operating characteristic curve analyses revealed that the physical activity thresholds that best discriminated between low/good attention capacities were ≥41 min·day(-1) for moderate, ≥12 min·day(-1) for vigorous, and ≥58 min·day(-1) for MVPA.
These findings suggest that promoting MVPA may be have a beneficial effect on attention capacity, an important component of cognition, in adolescents.
No preview · Article · Oct 2015 · The Journal of pediatrics
[Show abstract][Hide abstract] ABSTRACT: To distinguish children with chemotherapy-induced febrile neutropenia (FN) at low risk of severe infection, the variables that are significant risk factors must be identified. Our objective was to identify them by applying evidence-based standards. This retrospective 2-center cohort study included all episodes of chemotherapy-induced FN in children in 2005 and 2006. The medical history, clinical, and laboratory data available at admission were collected. Severe infection was defined by bacteremia, a positive culture of a normally sterile body fluid, invasive fungal infection, or localized infection at high risk of extension. Univariate analysis identified potential predictive variables. A generalized mixed model was used to determine the adjusted variables that predict severe infection. We analyzed 372 FN episodes. Severe infections occurred in 16.1% of them. Variables predictive of severe infection at admission were: disease with high risk of prolonged neutropenia (adjusted odds ratio [aOR]=2.5), blood cancer (aOR=1.9), fever ≥38.5°C (aOR=3.7), and C-reactive protein level ≥90 mg/L (aOR=4.5). Now that we have identified these variables significantly associated with the risk of severe infection, they must be validated prospectively before combining the best predictive variables in a decision rule that can be used to distinguish children at low risk.
No preview · Article · Oct 2015 · Journal of Pediatric Hematology/Oncology
[Show abstract][Hide abstract] ABSTRACT: Objective: The aim of this study was to the determine impact of severe esophageal anastomotic leak (SEAL) upon long-term survival and locoregional cancer recurrence. Background: The impact of SEAL upon long-term survival after esophageal resection remains inconclusive with a number of studies demonstrating conflicting results. Methods: A multicenter database for the surgical treatment of esophageal cancer collected data from 30 university hospitals (2000-2010). SEAL was defined as a Clavien-Dindo III or IV leak. Patients with SEAL were compared with those without in terms of demographics, tumor characteristics, surgical technique, morbidity, survival, and recurrence. Results: From a database of 2944 operated on for esophageal cancer between 2000 and 2010, 209 patients who died within 90 days of surgery and 296 patients with a R1/R2 resection were excluded, leaving 2439 included in the final analysis; 208 (8.5%) developed a SEAL and significant independent association was observed with low hospital procedural volume, cervical anastomosis, tumoral stage III/IV, and pulmonary and cardiovascular complications. SEAL was associated with a significant reduction in median overall (35.8 vs 54.8 months; P = 0.002) and disease-free (34 vs 47.9 months; P = 0.005) survivals. After adjustment of confounding factors, SEAL was associated with a 28% greater likelihood of death [hazard ratio = 1.28; 95% confidence interval (CI): 1.04-1.59; P = 0.022], as well as greater overall (OR = 1.35; 95% CI: 1.15-1.73; P = 0.011), locoregional (OR = 1.56; 95% CI: 1.05-2.24; P = 0.030), and mixed (OR = 1.81; 95% CI: 1.20-2.71; P = 0.014) recurrences. Conclusions: This large multicenter study provides strong evidence that SEAL adversely impacts cancer prognosis. The mechanism through which SEAL increases local recurrence is an important area for future research.
No preview · Article · Oct 2015 · Annals of Surgery
[Show abstract][Hide abstract] ABSTRACT: Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients.
This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs.
BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015.
ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013).
[Show abstract][Hide abstract] ABSTRACT: Introduction:
Daily or serial evaluation of multiple organ dysfunction syndrome (MODS) scores may provide useful information. We aimed to validate the daily (d) PELOD-2 score using the set of seven days proposed with the previous version of the score.
In all consecutive patients admitted to nine pediatric intensive care units (PICUs) we prospectively measured the dPELOD-2 score at day 1, 2, 5, 8, 12, 16, and 18. PICU mortality was used as the outcome dependent variable. The discriminant power of the dPELOD-2 scores was estimated using the area under the ROC curve and the calibration using the Hosmer-Lemeshow chi-square test. We used a logistic regression to investigate the relationship between the dPELOD-2 scores and outcome, and between the change in PELOD-2 score from day 1 and outcome.
We included 3669 patients (median age 15.5 months, mortality rate 6.1%, median length of PICU stay 3 days). Median dPELOD-2 scores were significantly higher in nonsurvivors than in survivors (p < 0.0001). The dPELOD-2 score was available at least at day 2 in 2057 patients: among the 796 patients without MODS on day 1, 186 (23.3%) acquired the syndrome during their PICU stay (mortality 4.9% vs. 0.3% among the 610 who did not; p < 0.0001). Among the 1261 patients with MODS on day 1, the syndrome worsened in 157 (12.4%) and remained unchanged or improved in 1104 (87.6%) (mortality 22.9% vs. 6.6%; p < 0.0001). The AUC of the dPELOD-2 scores ranged from 0.75 (95% CI: 0.67-0.83) to 0.89 (95% CI: 0.86-0.91). The calibration was good with a chi-square test between 13.5 (p = 0.06) and 0.9 (p = 0.99). The PELOD-2 score on day 1 was a significant prognostic factor; the serial evaluation of the change in the dPELOD-2 score from day1, adjusted for baseline value, demonstrated a significant odds ratio of death for each of the 7 days.
This study suggests that the progression of the severity of organ dysfunctions can be evaluated by measuring the dPELOD-2 score during a set of 7 days in PICU, providing useful information on outcome in critically ill children. Its external validation would be useful.