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Biere S.S.A.Y.,VU University Amsterdam | Maas K.W.,VU University Amsterdam | Bonavina L.,University of Milan | Rosman C.,Canisius Wilhelmina Hospital | And 6 more authors.
The Lancet | Year: 2012

Surgical resection is regarded as the only curative option for resectable oesophageal cancer, but pulmonary complications occurring in more than half of patients after open oesophagectomy are a great concern. We assessed whether minimally invasive oesophagectomy reduces morbidity compared with open oesopha gectomy. Methods We did a multicentre, open-label, randomised controlled trial at five study centres in three countries between June 1, 2009, and March 31, 2011. Patients aged 18-75 years with resectable cancer of the oesophagus or gastro-oesophageal junction were randomly assigned via a computer-generated random isation sequence to receive either open transthoracic or minimally invasive transthoracic oesophagectomy. Randomisation was stratified by centre. Patients, and investigators undertaking interventions, assessing outcomes, and analysing data, were not masked to group assignment. The primary outcome was pulmonary infection within the first 2 weeks after surgery and during the whole stay in hospital. Analysis was by intention to treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452. Findings We randomly assigned 56 patients to the open oesophagectomy group and 59 to the minimally invasive oesophagectomy group. 16 (29%) patients in the open oesophagectomy group had pulmonary infection in the first 2 weeks compared with five (9%) in the minimally invasive group (relative risk [RR] 0·30, 95% CI 0·12-0·76; p=0·005). 19 (34%) patients in the open oesophagectomy group had pulmonary infection in-hospital compared with seven (12%) in the minimally invasive group (0·35, 0·16-0·78; p=0·005). For in-hospital mortality, one patient in the open oesophagectomy group died from anastomotic leakage and two in the minimally invasive group from aspiration and mediastinitis after anastomotic leakage. Interpretation These findings provide evidence for the short-term benefits of minimally invasive oesopha gectomy for patients with resectable oesophageal cancer.


Davalos A.,Hospital Universitari Germans Trias i Pujol | Alvarez-Sabin J.,Hospital Universitari Of La Vall Dhebron | Castillo J.,Hospital Clinico Universitario Of Santiago | Diez-Tejedor E.,Hospital Universitario La Paz | And 8 more authors.
The Lancet | Year: 2012

Background Citicoline is approved in some countries for the treatment of acute ischaemic stroke. The drug has shown some evidence of efficacy in a pooled analysis. We sought to confirm the efficacy of citicoline in a larger trial. Methods We undertook a randomised, placebo-controlled, sequential trial in patients with moderate-to-severe acute ischaemic stroke admitted at university hospitals in Germany, Portugal, and Spain. Using a centralised minimisation process, patients were randomly assigned in a 1:1 ratio to receive citicoline or placebo within 24 h after the onset of symptoms (1000 mg every 12 h intravenously during the first 3 days and orally thereafter for a total of 6 weeks [2×500 mg oral tablets given every 12 h]). All study participants were masked. The primary outcome was recovery at 90 days measured by a global test combining three measures of success: National Institutes of Health Stroke Scale ≤1, modified Rankin score ≤1, and Barthel Index ≥95. Safety endpoints included symptomatic intracranial haemorrhage in patients treated with recombinant tissue plasminogen activator, neurological deterioration, and mortality. This trial is registered, NCT00331890. Results 2298 patients were enrolled into the study from Nov 26, 2006, to Oct 27, 2011. 37 centres in Spain, 11 in Portugal, and 11 in Germany recruited patients. Of the 2298 patients who gave informed consent and underwent randomisation, 1148 were assigned to citicoline and 1150 to placebo. The trial was stopped for futility at the third interim analysis on the basis of complete data from 2078 patients. The final randomised analysis was based on data for 2298 patients: 1148 in citicoline group and 1150 in placebo group. Global recovery was similar in both groups (odds ratio 1.03, 95% CI 0.86-1.25; p=0.364). No significant differences were reported in the safety variables nor in the rate of adverse events. Interpretation Under the circumstances of the ICTUS trial, citicoline is not efficacious in the treatment of moderateto-severe acute ischaemic stroke.


Fernandez-Ortega P.,Institute Catala dOncologia | Caloto M.T.,MSD | Chirveches E.,Hospital General Of Vic | Marquilles R.,Hospital Universitari Arnau Of Vilanova | And 9 more authors.
Supportive Care in Cancer | Year: 2012

Background Chemotherapy-induced nausea and vomiting (CINV) in cancer patients are common symptoms most feared by patients. The aim of this study was to analyze the impact of CINV associated to moderate/highly emetogenous chemotherapy regimens on patients' quality of life (QoL). Patients and methods Open, multicenter, prospective observational study was performed. Each patient filled out a patient diary for each cycle from the day before chemotherapy and for the next 5 days that included the number of emetic episodes, the intensity of nausea, and QoL evaluation (functional living index-emesis questionnaire). Results Datafrom202consecutivepatients fromnineuniversity hospitals were collected, but only data from 160 were analyzed (79.2 %). Most of the participants (70 %) were women with a mean age of 50 years (SD 1.2 years). The most frequent cancer sitewas breast (44%) followedby lung (16%) and76.3%were receiving highly emetogenous chemotherapy.Despite the use of antiemetic prophylaxis, patients experienced significant nausea and vomiting during 31 % (3.2 % during acute, 15.0 % during delayedphase,and13.2%duringbothphases) and45.1%(5.1% only during the acute phase, 23.5 % only during the delayed phase and 16.5%during both phases) of the cycles, respectively, having 44.5 % (nausea) and 39.3 % (emesis) of the cycles an impact on patients' QoL. Conclusions The results of the study confirm the detrimental effect of CINV on patients' QoL despite the use of antiemetic prophylaxis (5HT3 receptor antagonist, steroids, and dopamine receptor antagonists). It is mandatory to intensify the detection of CINV in order to improve the management of these important, albeit frequent, side effects of cancer treatments. © Springer-Verlag 2012.


Cho T.-H.,CNRS Research Center for Image Acquisition and Processing for Health | Nighoghossian N.,CNRS Research Center for Image Acquisition and Processing for Health | Mikkelsen I.K.,University of Aarhus | Derex L.,CNRS Research Center for Image Acquisition and Processing for Health | And 7 more authors.
Stroke | Year: 2015

Background and Purpose-The relative merits of reperfusion versus recanalization to predict tissue and clinical outcomes in anterior circulation stroke have been previously assessed using data acquired >12 hours postonset. To avoid late-occurring confounders such as non-nutritional reperfusion, futile recanalization and no-reflow phenomenon, we performed ultraearly assessment of reperfusion and recanalization. Methods-From a multicenter prospective database, 46 patients with acute magnetic resonance angiography-visible occlusion and in whom both reperfusion and recanalization were assessed on follow-up magnetic resonance imaging ≤6 hours of symptom onset were identified. Multiple linear regressions modeled salvaged penumbra, diffusion-weighted imaging lesion growth, and final infarct at 1 month using baseline clinical and imaging parameters and acute reperfusion or recanalization. Best predictors were determined with the Akaike information criterion. Univariate and multivariate logistic regressions identified the clinical and imaging predictors of clinical outcome. Results-Admission magnetic resonance imaging showed M1 occlusion in 15 (33%) patients; median penumbra volume was 13.4 mL. Acute reperfusion was observed in 27 (59%) patients; 42% of nonrecanalized patients demonstrated reperfusion. The dichotomized classification of reperfusion and recanalization was discordant (P=0.0002). Reperfusion ≤6 hours was a significant (P<0.05) predictor of increased penumbra salvage, reduced lesion growth, and final infarct size. Recanalization did not improve model accuracy. Reperfusion, but not recanalization, was significantly associated with good clinical outcome in logistic regressions. Conclusions-Reperfusion ≤6 hours was consistently superior to recanalization in predicting tissue and clinical outcome. Reperfusion without recanalization was frequent and probably related to retrograde reperfusion through leptomeningeal collaterals. Acute reperfusion was the strongest predictor of, and may therefore, represent a reliable surrogate for, clinical outcome. © 2015 American Heart Association, Inc.


Arnal-Garcia C.,Hospital Virgen Of Las Nieves | Garcia-Montero M.R.,Hospital Virgen Of La Salud | Malaga I.,University of Oviedo | Millan-Pascual J.,Hospital Complex Mancha Centro | And 3 more authors.
European Journal of Paediatric Neurology | Year: 2013

Background: Not all pediatric patients with relapsing-remitting multiple sclerosis (MS) may respond to traditional disease-modifying therapies. Natalizumab has been shown to be effective but is currently only approved in adults. Objective: To analyze the safety and efficacy of natalizumab in patients under 18 years of age diagnosed with MS. Method: Data for pediatric patients with MS treated with natalizumab in a compassionate use setting were retrospectively collected and analyzed. Results: Valid data were obtained for nine patients under 18 years from seven different centers (mean age, 15 years 4 months [range 9.8-17.7]; 5 were boys). Patients received a median of 17 infusions of natalizumab (range, 2-31) and eight received at least 12 infusions. For these 8 patients, the median score on the Expanded Disability Status Scale decreased from 3.0 to 1.0 and the median annualized relapse rate decreased from 3.0 to 0. After 12 months, no patients reported gadolinium-enhancing lesions compared to seven at baseline. Four post-baseline adverse events occurred and one patient discontinued due to hypersensitivity reaction. Conclusion: Natalizumab is a highly effective treatment as a second-line option in pediatric patients. In as far as the limited numbers allowed comparisons, the safety and efficacy of natalizumab in children was in line with the experience published in adult populations. © 2012 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.


Julia D.,Hospital Universitari Of Girona Dr Josep Trueta | Baldo X.,Hospital Universitari Of Girona Dr Josep Trueta | Gomez N.,Hospital Universitari Of Girona Dr Josep Trueta | Marmolb E.,Hospital Universitari Of Girona Dr Josep Trueta
European Journal of Cardio-thoracic Surgery | Year: 2012

Migration of Kirschner wires after fracture fixation is a rare complication. Several cases of intrathoracic migration after humeral or clavicle fixation with this technique have been reported though. We describe an even rarer case where a wire migrated from the proximal humerus to the abdomen perforating the left thoracic cavity and hemidiaphragm. The distal end of the wire was located next to the spleen and its proximal end at the fifth intercostal space. This particular case could be managed with a simple direct removal through an incission at the fifth intercostal space. The postoperative course was uneventful. © The Author 2011. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.


Cheng B.,University of Hamburg | Forkert N.D.,University of Hamburg | Zavaglia M.,University of Hamburg | Hilgetag C.C.,University of Hamburg | And 12 more authors.
Stroke | Year: 2014

Background and Purpose: In the early days after ischemic stroke, information on structural brain damage from MRI supports prognosis of functional outcome. It is rated widely by the modified Rankin Scale that correlates only moderately with lesion volume. We therefore aimed to elucidate the influence of lesion location from early MRI (days 2-3) on functional outcome after 1 month using voxel-based lesion symptom mapping. METHODS-: We analyzed clinical and MRI data of patients from a prospective European multicenter stroke imaging study (I-KNOW). Lesions were delineated on fluid-attenuated inversion recovery images on days 2 to 3 after stroke onset. We generated statistic maps of lesion contribution related to clinical outcome (modified Rankin Scale) after 1 month using voxel-based lesion symptom mapping. RESULTS-: Lesion maps of 101 patients with middle cerebral artery infarctions were included for analysis (right-sided stroke, 47%). Mean age was 67 years, median admission National Institutes of Health Stroke Scale was 11. Mean infarct volumes were comparable between both sides (left, 37.5 mL; right, 43.7 mL). Voxel-based lesion symptom mapping revealed areas with high influence on higher modified Rankin Scale in regions involving the corona radiata, internal capsule, and insula. In addition, asymmetrically distributed impact patterns were found involving the right inferior temporal gyrus and left superior temporal gyrus. CONCLUSIONS-: In this group of patients with stroke, characteristic lesion patterns in areas of motor control and areas involved in lateralized brain functions on early MRI were found to influence functional outcome. Our data provide a novel map of the impact of lesion localization on functional stroke outcome as measured by the modified Rankin Scale. © 2014 American Heart Association, Inc.


Galinovic I.,Charité - Medical University of Berlin | Puig J.,Hospital Universitari Of Girona Dr Josep Trueta | Neeb L.,Charité - Medical University of Berlin | Guibernau J.,Hospital Universitari Of Girona Dr Josep Trueta | And 7 more authors.
Stroke | Year: 2014

BACKGROUND AND PURPOSE - : WAKE-UP is a randomized, placebo-controlled MRI-based trial of thrombolysis in wake-up stroke using the mismatch between a lesion's visibility in diffusion-weighted imaging and fluid-attenuated inversion recovery (FLAIR) sequences as its main imaging inclusion criterion. Visual judgment of lesion conspicuity on FLAIR is however methodically limited by moderate inter-rater agreement. We therefore sought to improve rating homogeneity by incorporating quantitative signal intensity measurements. METHODS - : One hundred forty-three data sets of patients with acute ischemic stroke were visually rated by 8 raters with respect to WAKE-UP study inclusion and exclusion criteria, and inter-rater agreement was calculated. A subanalysis was performed on 45 cases to determine a threshold value of relative signal intensity (rSI) between the ischemic lesion and contralateral healthy tissue which best corresponded to a visually established verdict of FLAIR positivity. The usefulness of this threshold in improving inter-rater agreement was evaluated in an additional sample of 50 patients. RESULTS - : Inter-rater agreement for inclusion into the WAKE-UP trial was 73% with a free-marginal κ of 0.46. A threshold of rSI which best correlated with the visual rating of lesions as FLAIR positive was 1.20. The addition of rSI measurements to visual evaluation did not change the inter-rater agreement. CONCLUSIONS - : Introducing a semiquantitative measure for FLAIR rSI did not improve the agreement between individual raters. However, enhancing visual assessment with rSI measurements can provide reassurance to local investigators in cases of uncertainty. © 2014 American Heart Association, Inc.


Puig J.,Hospital Universitari Dr Josep Trueta | Puig J.,University of Barcelona | Pedraza S.,Hospital Universitari Dr Josep Trueta | Demchuk A.,University of Calgary | And 9 more authors.
American Journal of Neuroradiology | Year: 2012

BACKGROUND AND PURPOSE: Little is known about the factors that determine recanalization after intravenous thrombolysis. We assessed the value of thrombus Hounsfield unit quantification as a predictive marker of stroke subtype and MCA recanalization after intravenous rtPA treatment. MATERIALS AND METHODS: NCCT scans and CTA were performed on patients with MCA acute stroke within 4.5 hours of symptom onset. Demographics, stroke severity, vessel hyperattenuation, occlusion site, thrombus length, and time to thrombolysis were recorded. Stroke origin was categorized as LAA, cardioembolic, or indeterminate according to TOAST criteria. Two blinded neuroradiologists calculated the Hounsfield unit values for the thrombus and contralateral MCA segment. We used ROC curves to determine the rHU cutoff point to discriminate patients with successful recanalization from those without. We assessed the accuracy (sensitivity, specificity, and positive and negative predictive values) of rHU in the prediction of recanalization. RESULTS: Of 87 consecutive patients, 45 received intravenous rtPA and only 15 (33.3%) patients had acute recanalization. rHU values and stroke mechanism were the highest predictive factors of recanalization. The Matthews correlation coefficient was highest for rHU (0.901). The sensitivity, specificity, and positive and negative predictive values for lack of recanalization after intravenous rtPA for rHU ≤ 1.382 were 100%, 86.67%, 93.75%, and 100%, respectively. LAA thrombi had lower rHU than cardioembolic and indeterminate stroke thrombi (P = .004). CONCLUSIONS: The Hounsfield unit thrombus measurement ratio can predict recanalization with intravenous rtPA and may have clinical utility for endovascular treatment decision making.


Guarch Ibanez B.,Hospital Universitari Of Girona Dr Josep Trueta | Bunuel Alvarez J.C.,ABS Girona 4 | Lopez Bermejo A.,Hospital Universitari Of Girona Dr Josep Trueta | Mayol Canals L.,Hospital Universitari Of Girona Dr Josep Trueta
Anales de Pediatria | Year: 2011

Introduction: The aim of this systematic review is to assess whether antibacterial agents are more effective than either placebo or no intervention at all in the treatment of acute bacterial sinusitis. Patients and methods: We reviewed the databases and search engines: PubMed, EMBASE, Cochrane Central Register of Controlled Trials and Google Scholar to identify randomized clinical trials (RCTs) in children comparing antibiotics versus placebo. Sinusitis was considered as the persistence of clinically compatible symptoms for at least 10 days. The methodological quality was assessed using the Jadad scale. Four RCTs were selected. We studied the following variables: cure, clinical improvement (on days 10 to 14), relapse-recurrence (from day 14 to day 60) and presence of adverse effects. The results were combined using meta-analysis. We used the fixed effects model or random model depending on whether or not there was heterogeneity. We estimated the combined relative risk (RR) and 95% confidence interval. Results: Only two RCTs had a Jadad scale score ≥3. Variable cure-improvement (4 RCTs): RR 1.11 (95% CI: 0.9 to 1.3). Variable relapse-recurrence (3 RCTs): RR 0.9 (95% CI: 0.6 to 1.5). Adverse effects (4 RCTs): 2.01 (95% CI 1.1 to 3.8). Conclusions: In children with acute sinusitis, antibacterial agents at the studied doses did not appear to provide benefit in terms of cure and improvement, assessed at 10 to 14 days of follow up. Similarly, the percentage of relapse-recurrence was not lower among children who received antibiotics. Antibiotics are associated more frequently with adverse effects. © 2010 Asociacioacute;n Española de Pediatría. Published by Elsevier España, S.L. All rights reserved.

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