Pamplona, Spain
Pamplona, Spain

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Pinero-Madrona A.,University of Murcia | Torro-Richart J.A.,Lluis Alcanyis Hospital | de Leon-Carrillo J.M.,University of Seville | de Castro-Parga G.,University of Vigo | And 5 more authors.
European Journal of Surgical Oncology | Year: 2015

Aims: The gold standard for detection of Sentinel Lymph Nodes (SLN) is a combined radioisotope and blue dye breast injection, using a gamma probe (GP). A new, non-radioactive method was developed, using a tracer (Sienna+®) of superparamagnetic iron oxide (SPIO) nanoparticles and a manual magnetometer (SentiMag®) (SM). The IMAGINE study was designed to show the non-inferiority of SM compared to GP, for the detection of SLN in breast cancer patients with SLN biopsy indication. Methods: From November 2013 to June 2014, 181 patients were recruited, and 321 nodes were excised and assessed ex-vivo. Readings from both SM and GP devices were recorded during transcutaneous, intraoperative, and ex-vivo detection attempts. Results: At the patient level, ex-vivo detection rates (primary variable) with SM and GP were 97.8% and 98.3% (concordance rate 99.4%). Transcutaneous and intraoperative detection rates were 95.5% vs 97.2%, and 97.2% vs 97.8% for SM and GP respectively (concordance rates>97%). At the node level, intraoperative and ex-vivo detection rates were 92.5% vs 89.3% and 91.0% vs 86.3% for SM and GP respectively. In all cases the non-inferiority of SM compared to SM was shown by ruling out a predefined non-inferiority margin of 5%. Conclusions: Our study showed the non-inferiority of SM as compared to GP. Moreover, the ex-vivo and intraoperative detection rates at the node level were slightly higher with SM. © 2015 Elsevier Ltd.


Guerrero D.,Biomedical Research Center | Guarch R.,Navarra Hospital Complex | Ojer A.,Biomedical Research Center | Casas J.M.,Hospital Complex of Navarra | And 5 more authors.
International Journal of Cancer | Year: 2011

Squamous cell carcinoma (SCC) of the vulva is a heterogeneous disease, associated or not with vulvar lichen sclerosus (LS). The precursor role of LS in vulvar cancer is unclear. We studied the epigenetic alterations of RASSF1A, RASSF2A, p16, TSP-1 and MGMT genes in vulvar SCCs, LS associated with SCC, isolated LS and normal vulvar skin. Gene hypermethylation and human papillomavirus presence were evaluated by methylation-specific PCR and PCR/reverse line blot, respectively. High-risk human papillomavirus types were present in 16.7% of the patients with vulvar SCC. There were increasing percentages of hypermethylation of genes from isolated LS to LS associated with vulvar SCC and vulvar SCC. The genes were hypermethylated more frequently in vulvar SCC associated with LS than in those not associated with LS, MGMT and RASSF2A being unmethylated in LS not associated with vulvar SCC. TSP-1 hypermethylation was related to recurrence in patients with vulvar cancer. Conclusions are as follows: (i) the epigenetic inactivation of genes is a common event in vulvar SCC and is also present in adjacent lesions, implying a possible precursor role for these alterations; (ii) MGMT and RASSF2A hypermethylation are present exclusively in vulvar SCC and LS associated with SCC, and absent from isolated LS; and (iii) TSP-1 hypermethylation is a bad prognosis factor in vulvar SCC. © 2010 UICC.


Lopez-Legarrea P.,University of Navarra | De La Iglesia R.,University of Navarra | Abete I.,Biodonostia Health Research Institute | Abete I.,CIBER ISCIII | And 8 more authors.
Nutrition and Metabolism | Year: 2013

Background: Dietary strategies seem to be the most prescribed therapy in order to counteract obesity regarding not only calorie restriction, but also bioactive ingredients and the composition of the consumed foods. Dietary total antioxidant capacity (TAC) is gaining importance in order to assess the quality of the diet. Methods. Ninety-six obese adults presenting metabolic syndrome (MetS) symptoms completed an 8-week intervention trial to evaluate the effects of a novel dietary program with changes in the nutrient distribution and meal frequency and to compare it with a dietary pattern based on the American Heart Association (AHA) guidelines.Anthropometric and biochemical parameters were assessed at baseline and at the endpoint of the study, in addition to 48-hours food dietary records. Results: Both diets equally (p > 0.05) improved MetS manifestations. Dietary TAC was the component which showed the major influence on body weight (p = 0.034), body mass index (p = 0.026), waist circumference (p = 0.083) and fat mass (p = 0.015) reductions. Transaminases (ALT and AST) levels (p = 0.062 and p = 0.004, respectively) were associated with lower TAC values. Conclusion: RESMENA diet was as effective as AHA pattern for reducing MetS features. Dietary TAC was the most contributing factor involved in body weight and obesity related markers reduction. Trial registration. © 2013 Lopez-Legarrea et al; licensee BioMed Central Ltd.


De La Iglesia R.,University of Navarra | Lopez-Legarrea P.,University of Navarra | Abete I.,BioDonostia Health Research Institute | Bondia-Pons I.,University of Navarra | And 7 more authors.
British Journal of Nutrition | Year: 2014

The long-term effects of dietary strategies designed to combat the metabolic syndrome (MetS) remain unknown. The present study evaluated the effectiveness of a new dietary strategy based on macronutrient distribution, antioxidant capacity and meal frequency (MEtabolic Syndrome REduction in NAvarra (RESMENA) diet) for the treatment of the MetS when compared with the American Heart Association guidelines, used as Control. Subjects with the MetS (fifty-two men and forty-one women, age 49 (se 1) years, BMI 36·11 (se 0·5)A kg/m2) were randomly assigned to one of two dietary groups. After a 2-month nutritional-learning intervention period, during which a nutritional assessment was made for the participants every 15A d, a 4-month self-control period began. No significant differences were found between the groups concerning anthropometry, but only the RESMENA group exhibited a significant decrease in body weight (A-A 1·7A %; P=A 0·018), BMI (A-A 1·7A %; P=A 0·019), waist circumference (A-A 1·8A %; P=A 0·021), waist:hip ratio (A-A 1·4A %; P=A 0·035) and android fat mass (A-A 6·9A %; P=A 0·008). The RESMENA group exhibited a significant decrease in alanine aminotransferase and aspartate aminotransferase (AST) concentrations (A-A 26·8A %; P=A 0·008 and-A 14·0A %; P=A 0·018, respectively), while the Control group exhibited a significant increase in glucose (7·9A %; P=A 0·011), AST (11·3A %; P=A 0·045) and uric acid (9·0A %; P


Alonso-Martinez J.L.,Hospital Complex of Navarra | Anniccherico-Sanchez F.J.,Hospital Complex of Navarra | Urbieta-Echezarreta M.A.,Hospital Complex of Navarra | Garcia-Sanchotena J.L.,Hospital Complex of Navarra | Herrero H.G.,Hospital Complex of Navarra
European Journal of Internal Medicine | Year: 2012

Background: After an acute pulmonary embolism (PE), the complete resolution of thromboemboli may not be routinely achieved. The rate of persistence may depend on the time and the diagnostic technique used for evaluation. Patients and methods: Patients were diagnosed with acute PE by means of computed tomography angiography (CTA). While they were receiving anticoagulant therapy, a second CTA was used to explore the rate of persistence of residual thromboemboli. During the initial episode, the plasma levels of Troponin I and natriuretic peptide, patient demographics, and hemodynamic and gas exchange data were evaluated as risk factors for persistence of pulmonary thromboemboli. Results: In this study 166 patients were diagnosed. A second CTA was not made in 46 (28%) patients for different reasons. In 120 (72%) patients a second CTA was made 4.5 [SD2.34] months after the initial episode (range 2-12 months). Complete clearance of thrombi occurred in 89 (74%, 95% CI 65-81) patients. Residual thrombi remained in 31 (26%, 95% CI 18-34) patients. In 6%, 13% and 81% of the patients the size of the residual thrombi was greater, similar to and smaller than initially diagnosed, respectively. The risk factors for residual thrombi included the thrombotic burden (OR 1.95), the alveolar to arterial difference of oxygen (OR 1.64), and the clinical antecedents of venous thromboembolic disease (OR 0.65). Conclusions: After 4.5 months of anticoagulant therapy, residual pulmonary thromboemboli persisted in 26% of the patients. The risk factors for residual thromboemboli include a greater initial thrombotic burden, a deeper gas exchange disturbation and a history of previous venous thromboembolism. © 2011 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.


Liechtenstein T.,University College London | Perez-Janices N.,University College London | Perez-Janices N.,Hospital Complex of Navarra | Escors D.,University College London | Escors D.,Hospital Complex of Navarra
Cancers | Year: 2013

The success of immunotherapy against infectious diseases has shown us the powerful potential that such a treatment offers, and substantial work has been done to apply this strategy in the fight against cancer. Cancer is however a fiercer opponent than pathogen-caused diseases due to natural tolerance towards tumour associated antigens and tumour-induced immunosuppression. Recent gene therapy clinical trials with viral vectors have shown clinical efficacy in the correction of genetic diseases, HIV and cancer. The first successful gene therapy clinical trials were carried out with onco(γ-)retroviral vectors but oncogenesis by insertional mutagenesis appeared as a serious complication. Lentiviral vectors have emerged as a potentially safer strategy, and recently the first clinical trial of patients with advanced leukemia using lentiviral vectors has proven successful. Additionally, therapeutic lentivectors have shown clinical efficacy for the treatment of HIV, X-linked adrenoleukodystrophy, and β-thalassaemia. This review aims at describing lentivectors and how they can be utilized to boost anti-tumour immune responses by manipulating the effector immune cells. © 2013 by the authors; licensee MDPI, Basel, Switzerland.


Cadore E.L.,Public University of Navarra | Casas-Herrero A.,Hospital Complex of Navarra | Zambom-Ferraresi F.,Public University of Navarra | Idoate F.,Clinic San Miguel | And 4 more authors.
Age | Year: 2014

This randomized controlled trial examined the effects of multicomponent training on muscle power output, muscle mass, and muscle tissue attenuation; the risk of falls; and functional outcomes in frail nonagenarians. Twenty-four elderly (91.9∈±∈4.1 years old) were randomized into intervention or control group. The intervention group performed a twice-weekly, 12-week multicomponent exercise program composed of muscle power training (8-10 repetitions, 40-60 % of the one-repetition maximum) combined with balance and gait retraining. Strength and power tests were performed on the upper and lower limbs. Gait velocity was assessed using the 5-m habitual gait and the time-up-and-go (TUG) tests with and without dual-task performance. Balance was assessed using the FICSIT-4 tests. The ability to rise from a chair test was assessed, and data on the incidence and risk of falls were assessed using questionnaires. Functional status was assessed before measurements with the Barthel Index. Midthigh lower extremity muscle mass and muscle fat infiltration were assessed using computed tomography. The intervention group showed significantly improved TUG with single and dual tasks, rise from a chair and balance performance (P∈<∈0.01), and a reduced incidence of falls. In addition, the intervention group showed enhanced muscle power and strength (P∈<∈0.01). Moreover, there were significant increases in the total and high-density muscle cross-sectional area in the intervention group. The control group significantly reduced strength and functional outcomes. Routine multicomponent exercise intervention should be prescribed to nonagenarians because overall physical outcomes are improved in this population. © 2013 American Aging Association.


PubMed | Hospital Complex of Navarra
Type: Journal Article | Journal: North American journal of medical sciences | Year: 2016

Studies aimed at assessing whether the emboli lodged in the central pulmonary arteries carry a worse prognosis than more peripheral emboli have yielded controversial results.To explore the impact on survival and long-term prognosis of central pulmonary embolism.Consecutive patients diagnosed with acute symptomatic pulmonary embolism by means of computed tomography (CT) angiography were evaluated at episode index and traced through the computed system of clinical recording and following-up. Central pulmonary embolism was diagnosed when thrombi were seen in the trunk or in the main pulmonary arteries and peripheral pulmonary embolism when segmental or subsegmental arteries were affected.A total of 530 consecutive patients diagnosed with pulmonary embolism were evaluated; 255 patients had central pulmonary embolism and 275 patients had segmental or subsegmental pulmonary embolism. Patients with central pulmonary embolism were older, had higher plasma levels of N-terminal of the prohormone brain natriuretic peptide (NT-ProBNP), troponin I, D-dimer, alveolar-arterial gradient, and shock index (P < .001 for each one). Patients with central pulmonary embolism had an all-cause mortality of 40% while patients with segmental or subsegmental pulmonary embolism (PE) had an overall mortality of 27% and odds ratio of 1.81 [confidence interval (CI) 95% 1.16-1.9]. Survival was lower in patients with central PE than in patients with segmental or subsegmental pulmonary embolism, even after avoiding confounders (P = .018).Apart from a greater impact on hemodynamics, gas exchange, and right ventricular dysfunction, central pulmonary embolism associates a shorter survival and an increased long-term mortality.


Optimal control of acute postoperative pain and prevention of chronic persistent pain in total knee arthroplasty (TKA) remain a challenge. The main hypothesis was that nerve blocks improve postoperative analgesia especially if perineural adjuvants are added.Immediate postoperative pain (24 h) was evaluated every hour in 639 patients using a verbal rating 11-point scale for patient self-reporting of pain (VRS-11). All patients received subarachnoid anesthesia and were randomly allocated in 8 groups: control group, epidural (EA) and single shots femoral (FNB) or adductor canal blocks (ACB), both with and without adjuvants: dexamethasone (+Dexa) or dexmedetomidine (+Dexm). Patients received intravenous analgesia (metamizole magnesium, dexketoprofen) and rescue analgesia when needed, intravenous (paracetamol and morphine) and/or regional (epidural boluses, femoral and sciatic nerve blocks). Demographics, orthopedic knee scores and adverse effects were also recorded.A 45.2% of patients had no immediate postoperative pain (p=0.0001). Rescue analgesia was needed in 48.8% of patients (p=0.0001): control group 72.8% of patients, EA 51.9%, FNB 40.0%, FNB+Dexa 33.3%, BNF+Dexm 41.3%, ACB 51.9%, ACB+Dexa 38.3% and ACB+Dexm 61.5% respectively. There were also differences in the total postoperative time without pain (p=0.0001), with mild (p=0.0001) or moderate pain (p=0.001) but not with severe pain (p=0.119).Peripheral nerve blocks with perineural dexamethasone improve postoperative analgesia for TKA. The addition of dexamethasone to adductor canal block open new possibilities to improve analgesia for TKA, and should be investigated as an alternative to femoral nerve block.


Guerrero-Setas D.,Navarrabiomed Miguel Servet Foundation | Perez-Janices N.,Navarrabiomed Miguel Servet Foundation | Ojer A.,Navarrabiomed Miguel Servet Foundation | Blanco-Fernandez L.,Navarrabiomed Miguel Servet Foundation | And 2 more authors.
Histopathology | Year: 2013

Aims: Lichen sclerosus (LS) is a chronic inflammatory disease of the genital skin of unknown aetiology. The role of LS in penile squamous cell carcinogenesis is not well characterized. HPV has been implicated in both, as have epigenetic changes. The presence of HPV and hypermethylation of the MGMT, p16, RASSF1, RASSF2, TSLC1 and TSP1 genes were studied in penile LS; MGMT, RASSF2 and TSLC1 hypermethylation in penile cancer and TSLC1 hypermethylation in vulvar LS and cancer extends previous results reported by our group. Methods and results: Thirty-seven HPV genotypes and hypermethylation were evaluated by PCR/reverse-line-blot and methylation-specific PCR respectively, in 27 preputial LS, 24 penile SCC, 30 vulvar SCC, 21 vulvar LS and 22 normal skin cases. HPV66 was present in 3.7% of penile LS cases, and p16 and RASSF2 hypermethylation were more frequent in penile cancer than in penile LS. p16, RASSF1, RASSF2 and TSP1 hypermethylation were similar in penile and vulvar LS. Conclusions: Gene hypermethylation is a common event in penile LS, and occurs approximately as frequently as in vulvar LS. Certain genes can be hypermethylated as an early or late event in LS or cancer, respectively. This suggests a possible sequential role for these alterations in the transition from benign to malignant lesions. © 2013 John Wiley & Sons Ltd.

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