49 results on '"García-Morales N"'
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2. Numerical modeling of a micropump without mobile parts actuated by thermocavitation bubbles
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García-Morales, N. G., Morales-Cruzado, B., Camacho-López, S., Romero-Méndez, R., Devia-Cruz, L. F., and Pérez-Gutiérrez, F. G.
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- 2021
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3. P751 Off-label dose escalation of Ustekinumab in Inflammatory Bowel Disease patients. Safety profil of different patterns
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García-Morales, N, primary, Agra-Blanco, I, additional, Gayoso-Rey, M, additional, Carmona, A, additional, Ayude, M, additional, De Castro Parga, M L, additional, and Rodriguez-Prada, I, additional
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- 2024
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4. P649 Long-term follow-up of the PROTDILAT study; LONG-PROTDILAT Prospective multicenter randomized comparative study of endoscopic treatment of strictures in Crohn's disease (CD): self-expandable metal stent (SEMS) vs endoscopic balloon dilatation (EBD)
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Ruiz Ramírez, P, primary, Loras, C, additional, Gornals, J, additional, Maia Bosca-Watts, M, additional, Brunet, E, additional, Iglesias, E, additional, Barrio, J, additional, Sicilia, B, additional, Dueñas, C, additional, Foruny, J R, additional, Martín-Arranz, M D, additional, Busquets, D, additional, Cerrillo, E, additional, García Morales, N, additional, Monfort, D, additional, Pérez-Roldán, F, additional, Pijoan, E, additional, González, B, additional, Reyes, J, additional, Torres, G, additional, Maristany, E, additional, Sanchiz, V, additional, Guardiola, J, additional, and Esteve, M, additional
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- 2024
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5. P916 Off-label dose escalation of Ustekinumab in Inflammatory Bowel Disease patients. Incidence rate, timing, dosing patterns and outcomes
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García-Morales, N, primary, Carmona, A, additional, Ayude, M, additional, Gayoso-Rey, M, additional, Agra-Blanco, I, additional, De Castro Parga, M L, additional, and Rodriguez-Prada, I, additional
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- 2024
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6. P886 Clinical course and therapeutic management 5 years after diagnosis, in a cohort of Spanish patients with Crohn′s disease diagnosed in the 21st century
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De Castro Parga, M L, primary, Dagraza, M, additional, Hernández, V, additional, García-Morales, N, additional, Pineda, J R, additional, and Rodriguez-Prada, I, additional
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- 2023
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7. P327 Characteristics of esophago-gastro-duodenal Crohn's disease in the biologic era: a nationwide study of the Young GETECCU Group
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López García, A, primary, Benítez, J M, additional, Maroto-Martín, C, additional, Fernández-Prada, S J, additional, Marquina, V, additional, Rodríguez, G E, additional, Mesonero, F, additional, Lucendo, A J, additional, Flórez-Díez, P, additional, Casanova, M J, additional, García-Morales, N, additional, Miranda, J, additional, Vicuña, M, additional, Font, G, additional, Suárez-Ferrer, C, additional, Bernal, L, additional, Peries, L, additional, Mínguez, A, additional, Tejedor, J, additional, Pérez-Galindo, P, additional, Elosua, A, additional, Lastiri, E A, additional, Brunet, E, additional, Llaó, J, additional, Rodríguez-Lago, I, additional, Ferreiro-Iglesias, R, additional, López, L, additional, González, I, additional, Ortega, S P, additional, Monsalve, S, additional, Márquez-Mosquera, L, additional, González-Vivó, M, additional, Murciano, F, additional, Zabana, Y, additional, and Barreiro-de Acosta, M, additional
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- 2023
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8. P104 Inflammatory complications of the pouch, and therapetic requirements after colectomy in patients with ulcerative colitis. Results from the RESERVO Study of GETECCU
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Mesonero Gismero, F, primary, Zabana, Y, additional, Fernández-Clotet, A, additional, Sola, A, additional, Caballol, B, additional, Leo, E, additional, García, M J, additional, Bertoletti, F, additional, Alejandro, M, additional, Suris, G, additional, Casis, B, additional, Ferreiro-Iglesias, R, additional, Calafat, M, additional, Jiménez, I, additional, Miranda-Bautista, J, additional, Lamuela, L J, additional, Fajardo, I, additional, Torrealba, L, additional, Nájera, R, additional, Sáiz, R M, additional, González, I, additional, Vicuña, M, additional, García-Morales, N, additional, Gutiérrez, A, additional, López-García, A, additional, Benítez, J M, additional, Rubín de Célix, C, additional, Tejido, C, additional, Brunet, E, additional, Bastón, I, additional, Rodríguez-Lago, I, additional, Baltar, R, additional, Huguet, J M, additional, Hermida, B, additional, Caballero-Mateos, A, additional, Sánchez-Guillén, L, additional, Bouhmidi, A, additional, Pajares, R, additional, López-Sanromán, A, additional, and Barreiro-de Acosta, M, additional
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- 2021
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9. P458 Effectiveness of biological therapy for pouchitis and other inflammatory complications ot the pouch. And the question of a second Anti-TNF after failure? Results from the RESERVO Study of GETECCU
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Mesonero Gismero, F, primary, Zabana, Y, additional, Fernández-Clotet, A, additional, Núñez, A, additional, Caballol, B, additional, Sola, A, additional, García, M J, additional, Bertoletti, F, additional, Mínguez, A, additional, Suris, G, additional, Casis, B, additional, Ferreiro-Iglesias, R, additional, Calafat, M, additional, Jiménez, I, additional, Miranda-Bautista, J, additional, Lamuela, L J, additional, Fajardo, I, additional, Torrealba, L, additional, Nájera, R, additional, Sáiz, R M, additional, González, I, additional, Vicuña, M, additional, García-Morales, N, additional, Gutiérrez, A, additional, López-García, A, additional, Benítez, J M, additional, Rubín de Célix, C, additional, Tejido, C, additional, Brunet, E, additional, Hernández, A, additional, Suárez, C, additional, Piquqeras, M, additional, Castaño, A, additional, Ramos, L, additional, Sobrino, A, additional, Rodríguez-Grau, M C, additional, Elosua, A, additional, Montoro, M, additional, López-Sanromán, A, additional, and Barreiro-de Acosta, M, additional
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- 2021
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10. P372 Effectiveness and safety of immunosuppressants for pouch disorders: results from the RESERVO Study of GETECCU
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Mesonero Gismero, F, primary, Zabana, Y, additional, Fernández-Clotet, A, additional, Leo, E, additional, Caballol, B, additional, Núñez, A, additional, García, M J, additional, Bertoletti, F, additional, Mínguez, A, additional, Suris, G, additional, Casis, B, additional, Ferreiro-Iglesias, R, additional, Calafat, M, additional, Jiménez, I, additional, Miranda-Bautista, J, additional, Lamuela, L J, additional, Fajardo, I, additional, Torrealba, L, additional, Nájera, R, additional, Sáiz, R M, additional, González, I, additional, Vicuña, M, additional, García-Morales, N, additional, Gutiérrez, A, additional, López-García, A, additional, Benítez, J M, additional, Rubín de Célix, C, additional, Tejido, C, additional, Brunet, E, additional, Hernández, A, additional, Suárez, C, additional, Piqueras, M, additional, Castaño, A, additional, Ramos, L, additional, Sobrino, A, additional, Rodríguez-Grau, M C, additional, Elosua, A, additional, Montoro, M, additional, López-Sanromán, A, additional, and Barreiro-de Acosta, M, additional
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- 2021
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11. Numerical modeling of a micropump without mobile parts actuated by thermocavitation bubbles
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García-Morales, N. G., primary, Morales-Cruzado, B., additional, Camacho-López, S., additional, Romero-Méndez, R., additional, Devia-Cruz, L. F., additional, and Pérez-Gutiérrez, F. G., additional
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- 2020
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12. Sprue-like enterophaty asscodated with valsartan
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del Val, A, García Campos M, and García Morales N
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- 2018
13. Prognostic value of red blood cell distribution width (RDW) and BISAP in predicting prognosis of acute pancreatitis
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del Val, A., primary, Tenías, J.M., additional, Béjar, S., additional, García Morales, N., additional, García Campos, M., additional, Cordón, G., additional, Ortuño, J.A., additional, and Higón, M.D., additional
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- 2019
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14. INFLUENCE OF BOWEL PREPARATION (BP) QUALITY ON THE DETECTION OF SERRATED POLYPS (SP): A PROSPECTIVE STUDY IN A REGIONAL FOBT-BASED COLORECTAL CANCER SCREENING PROGRAM
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Satorres, C, additional, García-Campos, M, additional, García-Morales, N, additional, Alonso, N, additional, Ponce, M, additional, Argüello, L, additional, Pons, V, additional, and Bustamante-Balen, M, additional
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- 2019
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15. A CRITICAL EVALUATION OF THE HAZEWINKEL CRITERIA FOR THE OPTICAL DIAGNOSIS OF SESSILE SERRATED LESIONS (SSL) AT THE BEGINNING OF A LEARNING PROCESS
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Bustamante-Balen, M, additional, Satorres, C, additional, García-Campos, M, additional, García-Morales, N, additional, Alonso, N, additional, Ponce, M, additional, Sanchez-Montes, C, additional, and Pons, V, additional
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- 2019
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16. P559 Real-life experience with long-term maintenance of golimumab in ulcerative colitis patients
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Iborra, M, primary, García-Morales, N, additional, Rubio, S, additional, Nantes Castillejo, O, additional, Bertoletti, F, additional, García-Planella, E, additional, Calvo, M, additional, Vera, I, additional, Taxonera, C, additional, Alba, C, additional, Boscá-Watts, M, additional, Martí-Aguado, D, additional, Ballester Ferrer, M P, additional, Sierra, M, additional, Cano-Sanz, N, additional, Mancenido, N, additional, Pajares-Villarroya, R, additional, Beltrán, B, additional, Cañada, A, additional, and Nos, P, additional
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- 2019
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17. Factores asociados con el éxito en intubación ileal en pacientes con anastomosis ileocólica
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García Morales, N, additional, Alonso Lázaro, N, additional, Álvarez De Sotomayor, D, additional, García Campos, M, additional, Satorres Paniagua, C, additional, Nevárez Heredia, A, additional, Ponce Romero, M, additional, Bustamante Balén, M, additional, Argüello Viúdez, L, additional, and Pons Beltrán, V, additional
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- 2017
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18. Extra-pancreatic necrosis volume as early predictor of severity in acute pancreatitis
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del Val, A., primary, Pamies, J., additional, Collado, J.J., additional, García Campos, M., additional, García Morales, N., additional, and Cordón, G., additional
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- 2017
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19. LA SEPTOTOMÍA ENDOSCÓPICA CON EL SISTEMA LIGASURE™ ES UN MÉTODO EFICAZ Y SEGURO PARA EL TRATAMIENTO DEL DIVERTÍCULO DE ZENKER
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Sáez González, E, primary, Alonso Lázaro, N, additional, García Morales, N, additional, Navarro Navarro, B, additional, Blázquez Martínez, MT, additional, Herreras López, J, additional, Ponce Romero, M, additional, Bustamante Balen, M, additional, Argüello Viudez, L, additional, and Pons Beltrán, V, additional
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- 2016
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20. Sex-related differences in the presentation, management and response to treatment of eosinophilic esophagitis: Cross sectional analysis of EoE CONNECT registry.
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Laserna-Mendieta EJ, Casabona-Francés S, Amorena E, Savarino EV, Pérez-Martínez I, Blas-Jhon L, Guardiola-Arévalo A, Coletta M, Pellegatta G, Guagnozzi D, Barrio J, Perello A, Betoré E, Krarup AL, Votto M, Gutiérrez-Junquera C, Naves JE, Oliva S, Teruel Sánchez-Vegazo C, Carrión S, Riva S, Espina-Cadenas S, Fernández-Fernández S, Llorente-Barrio M, Pascual-Lopez I, Masiques-Mas ML, Honrubia-López R, Dainese R, García-Morales N, Cobian J, Bisso-Zein JK, Roales V, Juan-Juan A, Rodríguez-Sánchez A, Feo-Ortega S, Martín-Domínguez V, Nantes-Castillejo Ó, Nicolay-Maneru J, Ghisa M, Maniero D, Suarez A, Maray I, Álvarez-García M, Granja-Navacerrada A, Penagini R, Racca F, Llerena-Castro R, Santander C, Arias Á, and Lucendo AJ
- Abstract
Background: Eosinophilic esophagitis (EoE) predominantly affects males across all ages; however, little is known about sex differences for other aspects of EoE., Objective: To investigate associations between sex and clinical presentation, endoscopic features, treatment choice and response in EoE patients in real-world practice., Methods: Cross-sectional analysis of the multicenter EoE CONNECT registry. The independent contribution of patients' sex and other relevant variables were statistically assessed by multivariate models., Results: A total of 2976 patients (76% male) were evaluated. Males were diagnosed at a younger age compared to females (32.7 ± 14.8 vs. 34.8 ± 15.6 years, respectively; p = 0.002) with similar diagnostic delay. EoE symptoms varied significantly between sexes, with food impaction predominating in males and dysphagia, heartburn, regurgitation and abdominal and epigastric pain in females. However, female sex contributed to higher symptom severity at diagnosis as measured with Dysphagia Symptom Score (R
2 = 0.57; p = 0.013) and presented higher peak eosinophil count in esophageal biopsies (p = 0.005). Males showed increased risk of stricturing or mixed phenotypes (adjusted OR 1.43, 95%CI:1.05-1.96; p = 0.024). No association was found between patients' sex and first-line treatment modality: proton pump inhibitors (PPI) were preferred over topical corticosteroids in patients with inflammatory phenotypes instead of stricturing or mixed phenotypes, and in patients who did not present food impaction. Both topical corticosteroids and dietary interventions were preferred over PPI in pediatric patients regardless of sex., Conclusions: Sex is associated with clinical and phenotypical presentation of EoE at diagnosis, with more fibrotic findings in males but higher symptom score in females., (© 2024 The Author(s). United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)- Published
- 2024
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21. Types, behaviour and therapeutic requirements of inflammatory pouch disorders: Results from the RESERVO study of GETECCU.
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Mesonero F, Zabana Y, Fernández-Clotet A, Solá A, Caballol B, Leo-Carnerero E, García MJ, Bertoletti F, Bastida G, Suris G, Casis B, Ferreiro-Iglesias R, Calafat M, Jiménez I, Miranda-Bautista J, Lamuela LJ, Fajardo I, Torrealba L, Nájera R, Sáiz-Chumillas RM, González-Partida I, Vicuña M, García-Morales N, Gutiérrez A, López-García A, Benítez JM, Rubín de Célix C, Tejido C, Brunet E, Hernandez-Camba A, Suárez C, Rodríguez-Lago I, Piqueras M, Castaño A, Ramos L, Sobrino A, Rodríguez-Grau MC, Elosua A, Montoro M, Baltar R, Huguet JM, Hermida B, Caballero-Mateos A, Sánchez-Guillén L, Bouhmidi A, Pajares R, Baston-Rey I, López-Sanromán A, Albillos A, and Barreiro-de Acosta M
- Abstract
Background and Aims: Inflammatory pouch disorders exhibit a heterogeneous clinical spectrum and therapeutic requirements have not been properly studied., Methods: This retrospective, multicentre study included ulcerative colitis patients with ileal pouch construction and were later diagnosed with an inflammatory pouch disorder between 1995 and 2020. Classifications, behaviour and therapies applied were recorded and compared in the long-term., Results: Overall, 338 patients were recruited. The most common disorders were pouchitis (n = 258, 76%), Crohn's disease of the pouch (n = 55, 16%) and cuffitis (n = 25, 7%). Pouchitis presented mainly as chronic (65.2%) and recurrent (87%) forms. Crohn's disease manifested as stricturing/penetrating in 53% of cases and perianal disease in 42%. Patients received multiple therapies: 86% antibiotics, 42% steroids, 27% immunosuppressants, 43% biologics and 27% surgery. Compared with pouchitis, Crohn's disease of the pouch was characterised by a later diagnosis (99 vs. 55 months, p < 0.001) and greater needs for immunosuppressants (OR 3.53, 1.79-6.94, p < 0.0001), biologics (OR 5.45, 2.78-10.6, p < 0.0001) and surgeries (OR 2.65, 1.43-4.89, p < 0.001)., Conclusions: Chronic pouchitis is the most common pouch disorder presentation. These entities have diverse therapeutics requirements, particularly for Crohn's disease of the pouch., Competing Interests: Conflict of interest F. Mesonero has served as a speaker for and received consulting fees from MSD, AbbVie, Takeda, Janssen, Pfizer, Ferring Pharmaceuticals, Kern Pharma, Dr. Falk Pharma, Galapagos, Chiesi Farmaceutici and Faes Farma. - Y. Zabana has received support for conference attendance, speaker fees, research support and consulting fees from AbbVie, Adacyte Therapeutics, Almirall, Amgen, Dr. Falk Pharma, Faes Farma, Ferring Pharmaceuticals, Janssen, MSD, Otsuka, Pfizer, Shire, Takeda, Galapagos, Boehringer Ingelheim and Tillotts Pharma AG. - A. Fernández-Clotet has served as a speaker for and received educational funding from Dr. Falk Pharma, Janssen, Takeda, Chiesi Farmaceutici and Pfizer. - B. Caballol has served as a speaker for and received consulting fees from MSD, AbbVie, Janssen, Takeda, Ferring Pharmaceuticals, Shire Pharmaceuticals and Faes Pharma. - E. Leo-Carnerero has served as a speaker and consultant for and received educational funding from AbbVie, Janssen, Takeda, Ferring Pharmaceuticals, Gilead, Pfizer and Dr. Falk Pharma. - M. J. García has received financial support for travel and educational activities from Janssen, Pfizer, AbbVie, Takeda, Kern Pharma, Faes Farma and Ferring Pharmaceuticals. - R. Ferreiro-Iglesias has received support for conference attendance, speaker fees, research support and consulting fees from AbbVie, Adacyte Therapeutics, Dr. Falk Pharma, Faes Farma, Ferring Pharmaceuticals, Janssen, MSD, Kern, Chiesi Farmaceutici, Gebro Pharma, Pfizer, Shire, Takeda and Tillotts Pharma AG. - M. Calafat has received support for conference attendance, speaker fees, research support and consulting fees from AbbVie, Adacyte Therapeutics, Dr. Falk Pharma, Ferring Pharmaceuticals, Janssen, Pfizer, Takeda, Gilead, Chiesi Farmaceutici and Tillotts Pharma AG. - J. Miranda has received support for conference attendance, speaker fees and consulting and advisory fees from AbbVie, Adacyte Therapeutics, Dr. Falk Pharma, Faes Farma, Ferring Pharmaceuticals, Janssen, Pfizer, Takeda and Tillotts Pharma AG. - L. Torrealba has served as a speaker for and received educational funding from AbbVie, Janssen, Takeda, Ferring Pharmaceuticals, Gilead, Pfizer, Dr. Falk Pharma and Tillotts Pharma AG. - R. Sáiz-Chumillas has served as a speaker for and received consulting fees from Janssen, Ferring Pharmaceuticals and Faes Farma. - A. López has received support for conference attendance, educational funding and speaker fees from Chiesi Farmaceutici, AbbVie, Janssen, Ferring Pharmaceuticals, Takeda, Pfizer and Tillotts Pharma AG. - C. Rubín de Célix has received educational funding from Ferring Pharmaceuticals, Tillotts Pharma AG, AbbVie, Norgine, MSD, Pfizer, Takeda and Janssen and is supported by a grant from the Ministerio de Economía y Competitividad (Instituto de Salud Carlos III, Río Hortega CM21/00025) and co-financed by the European Social Fund Plus (ESF+) ‘Co-financed by the European Union’. - E. Brunet has served as a speaker and consultant for and received educational funding from Janssen, Takeda, Ferring Pharmaceuticals, Kern Pharma, AbbVie and Chiesi Farmaceutici. - A. Hernández has served as a speaker for and received educational funding from AbbVie, Takeda, Kern Pharma, Pfizer, Janssen, Adacyte Therapeutics, Chiesi Farmaceutici, Galapagos and Ferring Pharmaceuticals. - I. González-Partida has received support for conference attendance and speaker fees from AbbVie, Dr. Falk Pharma, Ferring Pharmaceuticals, Janssen, MSD, Kern, Pfizer, Shire, Takeda and Tillotts Pharma AG. - I. Rodríguez-Lago has received financial support for travel and educational activities from or has served as an advisory board member for AbbVie, Adacyte Therapeutics, Celltrion, Chiesi Farmaceutici, Danone, Ferring Pharmaceuticals, Faes Farma, Janssen, Galapagos, MSD, Otsuka Pharmaceutical, Pfizer, Roche, Takeda and Tillotts Pharma. I. R.-L. has also received financial support for research from Tillotts Pharma AG and is supported by research grants from Gobierno Vasco – Eusko Jaurlaritza (grant no. 2020111061) and Biobizkaia HRI (grant no. BCB/I/LIB/22/008). - M. C. Rodríguez-Grau has served as a speaker for Takeda, Shire Pharmaceutics and Dr. Falk Pharma and has received education funding from Pfizer, Takeda, Janssen, MSD, Dr. Falk Pharma, Shire Pharmaceutics, Mylan, Norgine, Chiesi Farmaceutici, Faes Farma, Ferring Pharmaceuticals and AbbVie. - A. Elosua has served as a speaker for or has received educational funding from AbbVie, Adacyte Therapeutics, Takeda, Faes Farma, Ferring Pharmaceuticals, Janssen and Tillotts Pharma AG. - J. Huguet has received fees for educational activities, research projects, scientific meetings and advisory boards sponsored by MSD, Ferring Pharmaceuticals, AbbVie, Janssen, Biogen, Sandoz, Kern Pharma, Faes Farma and Takeda. - M. Barreiro de Acosta has served as a speaker, consultant and advisory member for and has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Gilead, Galapagos, BMS, Celgene, Pfizer, Sandoz, Biogen, Fresenius, Ferring Pharmaceuticals, Faes Farma, Dr. Falk Pharma, Chiesi Farmaceutici, Gebro Pharma, Adacyte Therapeutics and Vifor Pharma. Remaining authors declare that they have no known competing financial interest or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)
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- 2024
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22. Diagnosis of eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis in adults. A brief review.
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Fuentes-Valenzuela E, Delgado-Guillena P, Velamazan-Sandalinas R, Sánchez JJ, García-Morales N, Barrio J, and Lucendo AJ
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- Humans, Adult, Diagnosis, Differential, Eosinophilia diagnosis, Eosinophilic Esophagitis diagnosis, Eosinophilic Esophagitis complications, Gastritis diagnosis, Gastritis complications, Enteritis diagnosis, Enteritis complications
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- 2024
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23. Adherence to patient blood management strategy in patients with gastrointestinal bleeding: a prospective nationwide multicenter study.
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Tejedor-Tejada J, Ballester MP, Del Castillo-Corzo FJ, García-Mateo S, Domper-Arnal MJ, Parada-Vazquez P, Saiz-Chumillas RM, Jiménez-Moreno MA, Hontoria-Bautista G, Bernad-Cabredo B, Gómez C, Capilla M, Fernández-De La Varga M, Ruiz-Belmonte L, Lapeña-Muñoz B, Calvo Iñiguez M, Fraile-González M, Flórez-Díez P, Morales-Alvarado VJ, Delgado-Guillena PG, Cañamares-Orbis P, Saez-González E, García-Morales N, Montoro M, and Murcia-Pomares Ó
- Abstract
Introduction: Patient blood management (PBM) adherence in clinical practice is unclear. This real-world practice study assessed the management of patients with gastrointestinal (GI) bleeding after the implementation of the PBM strategy., Methods: This was a nationwide multicenter and prospective study involving consecutive adults with GI bleeding between March 2019 and March 2021. Patients were examined according to hemoglobin (Hb) level at admission (<7 g/dl, n = 93; 7-8 g/dl, n = 47; 8-9 g/dl, n = 61; and >9 g/dl, n = 249). Study outcomes measures were morbidity and mortality during hospitalization and at 3- and 6-month follow-up. Appropriate anemia or iron deficiency management was considered when adherence to PBM policy was higher than 75%., Results: A total of 450 patients (57.6% men, median age: 74 years, interquartile range: 63-82) were included. Overall, 55.1% and 59.3% of patients received transfusion and iron supplementation, respectively. The rates of appropriate transfusion and iron supplementation adherence were 90.9% (range: 86.9-93.5%, P = 0.109) and 81.8% (range: 78.5-85.1%, P = 0.041), depending on Hb level, respectively. No associations were observed between adherence to the PBM strategy and length of stay (P = 0.263) or risk of further bleeding (P = 0.742). Patients who were transfused [hazard ratio (HR): 0.79, 95% confidence interval (CI): 0.27-0.85] and iron supplemented (HR: 0.91, 95% CI: 0.38-1.41), however, appropriately achieved a lower risk of death. Age (HR: 1.12, 95% CI: 1.12-1.25) and further bleeding (HR: 39.08, 95% CI: 4.01-181.24) were poor prognostic factors. No serious adverse events were reported., Conclusions: In this nationwide study, there is a high level of adherence and safety of PBM for the treatment of GI bleeding. Adherence to the PBM strategy improved outcomes in patients with GI bleeding., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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24. Determinant factors for first-line treatment choice and effectiveness in pediatric eosinophilic esophagitis: an analysis of the EUREOS EoE CONNECT registry.
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Navarro P, Feo-Ortega S, Casabona-Francés S, Gutiérrez-Junquera C, Savarino EV, Amorena E, Fernández-Fernández S, Pérez-Martínez I, Oliva S, Barrio J, Masiques-Mas ML, Guardiola-Arévalo A, Guagnozzi D, Racca F, Betoré E, Votto M, Rodríguez-Sánchez A, Barrio ML, Blas-Jhon L, Sánchez-Vegazo CT, García-Morales N, Krarup AL, Dainese R, Martín-Dominguez V, García-Díaz A, Maniero D, Santander C, Arias Á, Laserna-Mendieta EJ, and Lucendo AJ
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- Humans, Male, Child, Female, Cross-Sectional Studies, Adolescent, Treatment Outcome, Child, Preschool, Infant, Adrenal Cortex Hormones therapeutic use, Adrenal Cortex Hormones administration & dosage, Diet Therapy methods, Administration, Topical, Eosinophilic Esophagitis drug therapy, Proton Pump Inhibitors therapeutic use, Registries
- Abstract
This study compared short-term effectiveness of proton pump inhibitors (PPI), swallowed topical corticosteroids (STC), and dietary therapies in reversing clinical and histological features in pediatric patients with eosinophilic esophagitits (EoE). Determinants for treatment choice and PPI therapy effectiveness were also assessed. A cross-sectional study analysis of patients under 18 years old recruited onto the multicenter EoE CONNECT registry was performed. Clinico-histological response was defined as symptomatic improvement plus a peak eosinophil count below 15 per high-power field after treatment. Effectiveness of first-line options used in monotherapy was compared. Overall, 393 patients (64% adolescents) receiving PPI, STC, or dietary monotherapy to induce EoE remission were identified. PPI was the preferred option (71.5%), despite STC providing the highest clinico-histological response rates (66%) compared to PPI (44%) and diet (42%). Logistic regression identified fibrotic features and recruitment at Italian sites independently associated to first-line STC treatment; age under 12 associated to dietary therapy over other options. Analysis of 262 patients in whom PPI effectiveness was evaluated after median (IQR) 96 (70-145) days showed that this effectiveness was significantly associated with management at pediatric facilities and use of high PPI doses. Among PPI responders, decrease in rings and structures in endoscopy from baseline was documented, with EREFS fibrotic subscore for rings also decreasing among responders (0.27 ± 0.63 vs. 0.05 ± 0.22, p < 0.001). Conclusion: Initial therapy choice for EoE depends on endoscopic phenotype, patient's age, and patients' origin. High PPI doses and treatment in pediatric facilities significantly determined effectiveness, and reversed fibrotic endoscopic features among responders. What is Known: • Proton pump inhibitors are widely used to induce and maintain remission in EoE in real practice, despite other first-line alternative therapies possibly providing higher effectiveness. What is New: • Proton pump inhibitors represent up to two-thirds of first-line monotherapies used to induce EoE remission in pediatric and adolescent patients with EoE. The choice of STC as first-line treatment for EoE was significantly associated with fibrotic features at baseline endoscopy and recruitment in Italian centers; age less than 12 years was associated with dietary therapy. • PPI effectiveness was found to be determined by use of high doses, attendance at pediatric facilities, presenting inflammatory instead of fibrotic or mixed phenotypes, and younger age. Among responders, PPI therapy reversed both inflammatory and fibrotic features of EoE after short-term treatment., (© 2024. The Author(s).)
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- 2024
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25. Adaptation and validation of an abbreviated version of the SIPAT integrated psychosocial risk scale in patients with liver cirrhosis candidates for liver transplantation (SIPAT-11).
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García Morales N, Gutiérrez Morato S, Castillo Cejas C, Fernández de la Varga M, Menéndez Rodríguez M, Aguilera V, Benlloch S, Menéndez Rodríguez L, Seoane Pillado T, and Cubiella J
- Abstract
Introduction: Patients with liver cirrhosis who are candidates for liver transplantation must be evaluated both clinically and socially in order to obtain the optimal outcomes and avoid futile therapeutic measures. For the evaluation of the social aspects in these patients, no validated scale in Spanish is available. The SIPAT (Stanford Integrated Psychosocial Assessment for Transplantation) scale is an instrument that measures the social, family and psychological aspects in candidates for solid organ transplantation. The objective of this study is to adapt and validate an abbreviated version of the SIPAT scale in Spanish for patients with liver cirrhosis., Material and Methods: Prospective observational study carried out in the Hepatology Unit of the La Fe Unversity Hospital in Valencia, by questionnaire validation methodology. To analyze the reliability of the questionnaire, the internal consistency of all variables was calculated, for variability an exploratory factor analysis, and for stability the test-retest test was carried out., Results: 96 patients who were admitted for decompensated cirrhosis to the Hepatology Unit of the La Fe Hospital in Valencia between November 1, 2017 and January 31, 2017 were selected. 84% were men, the mean age was 60.01 (SD 10.12) years. In 73.2% of those admitted, the etiology of cirrhosis was alcoholic. 14.4% had a Child's stage A, 57.7% B and 27.8% C. The internal consistency of all variables reached a Cronbach's Alpha of 0.766. In the exploratory factor analysis, 6 dimensions of the questionnaire were identified that explain 84.27% of the total variability. To see the stability of the instrument, the measurement was repeated at 2 and 6 months of follow-up, obtaining in the test-retest a kappa agreement of 0.612 and 0.565 respectively., Conclusion: The SIPAT-11 questionnaire has good psychometric characteristics in cirrhotic patients who are candidates for liver transplantation. It is easy to complete and can be administered by professionals who are not specialists in the area of Mental Health., (Copyright © 2024 Elsevier España, S.L.U. All rights reserved.)
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- 2024
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26. Effectiveness of Helicobacter pylori Treatments According to Antibiotic Resistance.
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Bujanda L, Nyssen OP, Ramos J, Bordin DS, Tepes B, Perez-Aisa A, Pavoni M, Castro-Fernandez M, Lerang F, Leja M, Rodrigo L, Rokkas T, Kupcinskas J, Jonaitis L, Shvets O, Gasbarrini A, Simsek H, Phull PS, Buzás GM, Machado JC, Boltin D, Boyanova L, Tonkić A, Marlicz W, Venerito M, Vologzanina L, Fadieienko GD, Fiorini G, Resina E, Muñoz R, Cano-Català A, Puig I, García-Morales N, Hernández L, Moreira L, Megraud F, Morain CO, Montes M, and Gisbert JP
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- Adult, Humans, Anti-Bacterial Agents pharmacology, Bismuth pharmacology, Clarithromycin pharmacology, Drug Resistance, Microbial, Drug Therapy, Combination, Levofloxacin pharmacology, Metronidazole pharmacology, Prospective Studies, Tinidazole pharmacology, Helicobacter Infections drug therapy, Helicobacter Infections microbiology, Helicobacter pylori
- Abstract
Introduction: Antibiotic resistance is one of the main factors that determine the efficacy of treatments to eradicate Helicobacter pylori infection. Our aim was to evaluate the effectiveness of first-line and rescue treatments against H. pylori in Europe according to antibiotics resistance., Methods: Prospective, multicenter, international registry on the management of H. pylori (European Registry on H. pylori Management). All infected and culture-diagnosed adult patients registered in the Spanish Association of Gastroenterology-Research Electronic Data Capture from 2013 to 2021 were included., Results: A total of 2,852 naive patients with culture results were analyzed. Resistance to clarithromycin, metronidazole, and quinolones was 22%, 27%, and 18%, respectively. The most effective treatment, regardless of resistance, were the 3-in-1 single capsule with bismuth, metronidazole, and tetracycline (91%) and the quadruple with bismuth, offering optimal cure rates even in the presence of bacterial resistance to clarithromycin or metronidazole. The concomitant regimen with tinidazole achieved an eradication rate of 99% (90/91) vs 84% (90/107) with metronidazole. Triple schedules, sequential, or concomitant regimen with metronidazole did not achieve optimal results. A total of 1,118 non-naive patients were analyzed. Resistance to clarithromycin, metronidazole, and quinolones was 49%, 41%, and 24%, respectively. The 3-in-1 single capsule (87%) and the triple therapy with levofloxacin (85%) were the only ones that provided encouraging results., Discussion: In regions where the antibiotic resistance rate of H. pylori is high, eradication treatment with the 3-in-1 single capsule, the quadruple with bismuth, and concomitant with tinidazole are the best options in naive patients. In non-naive patients, the 3-in-1 single capsule and the triple therapy with levofloxacin provided encouraging results., (Copyright © 2023 by The American College of Gastroenterology.)
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- 2024
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27. Effectiveness and safety of azathioprine for inflammatory pouch disorders: results from the RESERVO study of GETECCU.
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Mesonero F, Zabana Y, Fernández-Clotet A, Leo-Carnerero E, Caballol B, Núñez-Ortiz A, García MJ, Bertoletti F, Mínguez A, Suris G, Casis B, Ferreiro-Iglesias R, Calafat M, Jiménez I, Miranda-Bautista J, Lamuela LJ, Fajardo I, Torrealba L, Nájera R, Sáiz-Chumillas RM, González I, Vicuña M, García-Morales N, Gutiérrez A, López-García A, Benítez JM, Rubín de Célix C, Tejido C, Brunet E, Hernández-Camba A, Suárez C, Rodríguez-Lago I, Piqueras M, Castaño A, Ramos L, Sobrino A, Rodríguez-Grau MC, Elosua A, Montoro M, Baltar R, Huguet JM, Hermida B, Caballero-Mateos A, Sánchez-Guillén L, Bouhmidi A, Pajares R, Baston-Rey I, López-Sanromán A, Albillos A, and Barreiro-de Acosta M
- Abstract
Background: The usefulness of thiopurines has been poorly explored in pouchitis and other pouch disorders., Objective: To evaluate the effectiveness and safety of azathioprine as maintenance therapy in inflammatory pouch disorders., Design: This was a retrospective and multicentre study., Methods: We included patients diagnosed with inflammatory pouch disorders treated with azathioprine in monotherapy. Effectiveness was evaluated at 1 year and in the long term based on normalization of stool frequency, absence of pain, faecal urgency or fistula discharge (clinical remission), or any improvement in these symptoms (clinical response). Endoscopic response was evaluated using the Pouchitis Disease Activity Index (PDAI)., Results: In all, 63 patients were included [54% males; median age, 49 (28-77) years]. The therapy was used to treat pouchitis ( n = 37) or Crohn's disease of the pouch ( n = 26). The rate of clinical response, remission and non-response at 12 months were 52%, 30% and 18%, respectively. After a median follow-up of 23 months (interquartile range 11-55), 19 patients (30%) were in clinical remission, and 45 (66%) stopped therapy. Endoscopic changes were evaluated in 19 cases. PDAI score decreased from 3 (range 2-4) to 1 (range 0-3). In all, 21 patients (33%) presented adverse events and 16 (25%) needed to stop therapy., Conclusion: Azathioprine may be effective in the long term for the treatment of inflammatory pouch disorders and could be included as a therapeutic option., Competing Interests: Francisco Mesonero has served as a speaker for and received consulting fees from MSD, AbbVie, Takeda, Janssen, Pfizer, Ferring, Kern-Pharma, Dr. Falk Pharma, Galapagos, Chiesi and Faes Farma. Yamile Zabana has received support for conference attendance, speaker fees, research support and consulting fees from AbbVie, Adacyte, Almirall, Amgen, Dr. Falk Pharma, FAES Pharma, Ferring, Janssen, MSD, Otsuka, Pfizer, Shire, Takeda, Galapagos, Boehringer Ingelheim and Tillots. Agnés Fernández-Clotet has served as a speaker for and received educational funding from Dr. Falk Pharma, Janssen, Takeda, Chiesi and Pfizer. Eduardo Leo-Carnerero has served as a speaker and consultant for and received educational funding from AbbVie, Janssen, Takeda, Ferring, Gilead, Pfizer and Dr. Falk Pharma. Andrea Núñez-Ortiz has received educational funding from Janssen, Takeda, Ferring and Pfizer. Berta Caballol has served as a speaker for and received consulting fees from MSD, AbbVie, Janssen, Takeda, Ferring, Shire Pharmaceuticals and Faes Pharma. Rocío Ferreiro-Iglesias has received support for conference attendance, speaker fees, research support and consulting fees from AbbVie, Adacyte, Dr. Falk Pharma, FAES Pharma, Ferring, Janssen, MSD, Kern, Chiesi, Gebro Pharma, Pfizer, Shire, Takeda and Tillots. José Miranda-Bautista has received support for conference attendance, speaker fees, and consulting and advisory fees from AbbVie, Adacyte, Dr. Falk Pharma, FAES Pharma, Ferring, Janssen, Pfizer, Takeda and Tillots. Leyanira Torrealba has served as a speaker for and received educational funding from AbbVie, Janssen, Takeda, Ferring, Gilead, Pfizer, Dr. Falk Pharma and Tillotts Pharma. Rosa María Sáiz-Chumillas has served as a speaker for and received consulting fees from Janssen, Ferring and Faes Farma. Alicia López-García has received support for conference attendance, educational funding and speaker fees from Chiesi, AbbVie, Janssen, Ferring, Takeda, Pfizer and Tillots. Cristina Rubín de Célix has received educational funding from Ferring, Tillotts Pharma, AbbVie, Norgine, MSD, Pfizer, Takeda and Janssen and is supported by a grant from the Ministerio de Economía y Competitividad (Instituto de Salud Carlos III, Rio Hortega CM21/00025) and co-financed by the European Social Fund Plus (ESF+) ‘Co-financed by the European Union’. Eduard Brunet has served as a speaker and consultant for and received educational funding from Janssen, Takeda, Ferring, Kern-Pharma, AbbVie and Chiesi. Alejandro Hernández-Camba has served as a speaker for and received educational funding from AbbVie, Takeda, Kern Pharma, Pfizer, Janssen, Adacyte Therapeutics, Chiesi, Galapagus and Ferring. Iago Rodríguez-Lago has received financial support for travelling and educational activities from or has served as an advisory board member for AbbVie, Adacyte, Celltrion, Chiesi, Danone, Dr. Falk Pharma, Ferring, Faes Farma, Janssen, Galapagos, MSD, Otsuka Pharmaceutical, Pfizer, Roche, Takeda and Tillotts Pharma. Iago Rodríguez-Lago has also received financial support for research from Tillotts Pharma and is supported by a research grant from Gobierno Vasco – Eusko Jaurlaritza [Grant No. 2020222004]. Alfonso Elosua has served as a speaker for and has received educational funding from AbbVie, Adacyte, Takeda, FAES Farma, Ferring, Janssen and Tillots Pharma. José María Huguet has received fees for educational activities, research projects, scientific meetings and advisory boards sponsored by MSD, Ferring, AbbVie, Janssen, Biogen, Sandoz, Kern Pharma, Faes Farma and Takeda. Manuel Barreiro-de Acosta has served as a speaker, consultant and advisory member for and has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Gilead, Celgene, Pfizer, Sandoz, Biogen, Fresenius, Ferring, Faes Farma, Dr. Falk Pharma, Chiesi, Gebro Pharma, Adacyte and Vifor Pharma., (© The Author(s), 2024.)
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- 2024
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28. Evaluation of Genetic Variants Associated with the Risk of Thiopurine-Related Pancreatitis: A Case Control Study from ENEIDA Registry.
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Guerra I, Barros F, Chaparro M, Benítez JM, Martín-Arranz MD, de Francisco R, Piqueras M, de Castro L, Carbajo AY, Bermejo F, Mínguez M, Gutiérrez A, Mesonero F, Cañete F, González-Muñoza C, Calvo M, Sicilia B, Alfambra E, Rivero M, Lucendo AJ, Tardillo CA, Almela P, Bujanda L, van Domselaar M, Ramos L, Fernández Sánchez M, Hinojosa E, Verdejo C, Gimenez A, Rodríguez-Lago I, Manceñido N, Pérez Calle JL, Moreno MDP, Delgado-Guillena PG, Antolín B, Ramírez de la Piscina P, Casanova MJ, Soto Escribano P, Martín Arranz E, Pérez-Martínez I, Mena R, García Morales N, Granja A, Boscá Watts MM, Francés R, Fernández C, Calafat M, Roig-Ramos C, Vera MI, Carracedo Á, Domènech E, and Gisbert JP
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- Humans, Female, Male, Adult, Case-Control Studies, Middle Aged, Genetic Predisposition to Disease, Risk Factors, Genetic Variation, Mercaptopurine adverse effects, Mercaptopurine therapeutic use, Pancreatitis chemically induced, Pancreatitis genetics, Inflammatory Bowel Diseases genetics, Inflammatory Bowel Diseases drug therapy, Registries
- Abstract
Introduction: Risk factors for developing pancreatitis due to thiopurines in patients with inflammatory bowel disease (IBD) are not clearly identified. Our aim was to evaluate the predictive pharmacogenetic risk of pancreatitis in IBD patients treated with thiopurines., Methods: We conducted an observational pharmacogenetic study of acute pancreatitis events in a cohort study of IBD patients treated with thiopurines from the prospectively maintained ENEIDA registry biobank of GETECCU. Samples were obtained and the CASR, CEL, CFTR, CDLN2, CTRC, SPINK1, CPA1, and PRSS1 genes, selected based on their known association with pancreatitis, were fully sequenced., Results: Ninety-five cases and 105 controls were enrolled; a total of 57% were women. Median age at pancreatitis diagnosis was 39 years. We identified 81 benign variants (50 in cases and 67 in controls) and a total of 35 distinct rare pathogenic and unknown significance variants (10 in CEL, 21 in CFTR, 1 in CDLN2, and 3 in CPA1). None of the cases or controls carried pancreatitis-predisposing variants within the CASR, CPA1, PRSS1, and SPINK1 genes, nor a pathogenic CFTR mutation. Four different variants of unknown significance were detected in the CDLN and CPA1 genes; one of them was in the CDLN gene in a single patient with pancreatitis and 3 in the CPA1 gene in 5 controls. After the analysis of the variants detected, no significant differences were observed between cases and controls., Conclusion: In patients with IBD, genes known to cause pancreatitis seem not to be involved in thiopurine-related pancreatitis onset., (© 2024 S. Karger AG, Basel.)
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- 2024
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29. Influence of social support and stressful life events on adherence to colorectal cancer screening using faecal occult blood test in Spanish medium risk population.
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Menéndez Rodríguez M, García-Morales N, Seoane Pillado T, Garau Ramírez J, Traver Salvador A, Hervás Jiménez Y, Fernández-Domínguez MJ, Menéndez Villalva C, and Cubiella J
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- Humans, Case-Control Studies, Early Detection of Cancer, Social Support, Occult Blood, Colorectal Neoplasms epidemiology
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Introduction: Colorectal cancer (CRC) is the second cause of cancer-related deaths worldwide. Five-year survival rate in Spain is 57%. The most important prognostic factor is the stage of the tumor at the diagnosis. CRC can be early diagnosed, but the adherence to screening programs is low (<50%). This study aims to ascertain the influence of social support and stressful life events on the adherence to the population screening of CRC with fecal occult blood test in Spanish average risk population., Methods: Multicenter case-control study. We conducted a simple random sampling among individuals invited to participate in the colorectal cancer screening program. We analyzed epidemiological and social variables associated with lifestyle and behavioral factors. We performed a descriptive and a bivariant analyses and a logistic regression analysis., Results: Four hundred and eight patients (237 cases and 171 controls) were included. Multivariant analyses showed independent association between higher adherence to the screening program and older age (OR: 1.06; 95% CI: 1.01-1.10), stable partner (OR: 1.77, 95% CI: 1.08-2.89) and wide social network (OR: 1.68; 95% CI: 1.07-2.66). Otherwise, lower adherence was associated to perceiving barriers to participate in the program (OR: 0.92; 95% CI: 0.88-0.96). We find a statistically significant association between lower adherence and high impact stressful life events in the bivariant analyses, and the tendency was maintained (OR: 0.63, 95% CI: 0.37-1.08) in the multivariant., Conclusion: Social variables decisively influence the adherence to colorectal cancer screening. The implementation of social interventions that improve social support, reduce impact of stressful life events and the design of screening programs that decrease the perceived barriers, will contribute to increase the participation on these programs. Secondary, the colorectal cancer diagnosis will be made in early-stages with the consequent mortality reduction., (Copyright © 2023 Elsevier España, S.L.U. All rights reserved.)
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- 2024
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30. History and clinical guidelines for chronic atrophic gastritis and the assessment of gastric cancer risk.
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Delgado-Guillena P, Velamazan-Sandalinas R, Jiménez Sánchez J, Fuentes-Valenzuela E, García-Morales N, Cuatrecasas M, Jimeno M, Moreira L, and Albéniz E
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- Humans, Risk, Gastric Mucosa, Gastritis, Atrophic complications, Gastritis, Atrophic diagnosis, Stomach Neoplasms diagnosis, Stomach Neoplasms etiology, Gastritis, Helicobacter pylori, Helicobacter Infections complications, Helicobacter Infections drug therapy
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- 2023
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31. Bismuth quadruple three-in-one single capsule three times a day increases effectiveness compared with the usual four times a day schedule: results from the European Registry on Helicobacter pylori Management (Hp-EuReg).
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Pérez-Aisa Á, Nyssen OP, Keco-Huerga A, Rodrigo L, Lucendo AJ, Gomez-Rodriguez BJ, Ortuño J, Perona M, Huguet JM, Núñez O, Fernandez-Salazar L, Barrio J, Lanas A, Iyo E, Romero PM, Fernández-Bermejo M, Gomez B, Garre A, Gomez-Camarero J, Lamuela LJ, Campillo A, de la Peña-Negro L, Dominguez Cajal M, Bujanda L, Burgos-Santamaría D, Bermejo F, González-Carrera V, Pajares R, Notari PA, Tejedor-Tejada J, Planella M, Jiménez I, Lázaro YA, Cuadrado-Lavín A, Pérez-Martínez I, Amorena E, Gonzalez-Santiago JM, Angueira T, Flores V, Martínez-Domínguez SJ, Pabón-Carrasco M, Velayos B, Algaba A, Ramírez C, Almajano EA, Castro-Fernandez M, Alcaide N, Sanz Segura P, Cano-Català A, García-Morales N, Moreira L, Mégraud F, O'Morain C, Calvet X, and Gisbert JP
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- Adult, Humans, Female, Middle Aged, Male, Bismuth adverse effects, Anti-Bacterial Agents therapeutic use, Drug Therapy, Combination, Metronidazole therapeutic use, Proton Pump Inhibitors, Registries, Amoxicillin therapeutic use, Helicobacter Infections drug therapy, Helicobacter pylori
- Abstract
Background: The recommended schedule for single capsule bismuth quadruple therapy (scBQT, Pylera) includes a proton pump inhibitor (PPI) two times a day and three scBQT capsules four times a day. Four times a day treatments are inconvenient and reduce adherence. In contrast, adherence improves with three times a day schedules. In clinical practice, many gastroenterologists use four capsule scBQT three times a day. However, the effectiveness and safety of this latter approach remain uncertain., Aim: To assess the effectiveness and safety of scBQT administered three times a day in the patients included in the European Registry on Helicobacter pylori Management (Hp-EuReg)., Methods: All Spanish adult patients registered in the Asociación Española de Gastroenterología Research Electronic Data Capture (REDCap) database from June 2013 to March 2021 receiving 10-day scBQT were analysed. Modified intention-to-treat effectiveness, adherence and the safety of scBQT given three times a day were calculated and compared with the four times a day schedule. A multivariate analysis was performed to determine independent factors predicting cure of the infection., Results: Of the 3712 cases, 2516 (68%) were four times a day and 1196 (32%) three times a day. Mean age was 51 years, 63% were women and 15% had a peptic ulcer. The three times a day schedule showed significantly better overall cure rates than four times a day (1047/1112, 94%; 95% CI 92.7 to 95.6 vs 2207/2423, 91%; 95% CI 89.9 to 92.2, respectively, p=0.002). Adherence and safety data were similar for both regimens. In the multivariate analysis, three times a day dosage, first-line therapy, use of standard or high-dose PPIs and adherence over 90% were significantly associated with cure of the infection., Conclusions: ScBQT prescribed three times a day was more effective than the traditional four times a day schedule. No differences were observed in treatment adherence or safety., Competing Interests: Competing interests: XC has received research grants and fees for lectures from Allergan. JPG has served as speaker, consultant and advisory member for or has received research funding from Mayoly Spindler, Allergan, Diasorin, Gebro Pharma and Richen. OPN received research funding from Allergan and Mayoly Spindler. Dr Bordin served as a lecturer for Astellas, AstraZeneca, KRKA, and Abbott. FM is a consultant for PHATHOM and DaVoltera and has received grants from Allergan, bioMerieux and Mobidiag. The remaining authors declare no conflict of interest., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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32. Corrigendum to "Differences between childhood- and adulthood-onset eosinophilic esophagitis: An analysis from the EoE connect registry" [Digestive and Liver Disease Volume 55, Issue 3, March 2023, Pages 350-359].
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Laserna-Mendieta EJ, Navarro P, Casabona-Francés S, Savarino EV, Pérez-Martínez I, Guagnozzi D, Barrio J, Perello A, Guardiola-Arévalo A, Betoré-Glaria ME, Blas-Jhon L, Racca F, Krarup AL, Gutiérrez-Junquera C, Fernández-Fernández S, De la Riva S, Naves JE, Carrión S, García-Morales N, Roales V, Rodríguez-Oballe JA, Dainese R, Rodríguez-Sánchez A, Masiques-Mas ML, Feo-Ortega S, Ghisa M, Maniero D, Suarez A, Llerena-Castro R, Gil-Simón P, de la Peña-Negro L, Granja-Navacerrada A, Alcedo J, Hurtado de Mendoza-Guena L, Pellegatta G, Pérez-Fernández MT, Santander C, Tamarit-Sebastián S, Arias Á, and Lucendo AJ
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- 2023
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33. Helicobacter pylori Diagnostic Tests Used in Europe: Results of over 34,000 Patients from the European Registry on Helicobacter pylori Management.
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García-Morales N, Pérez-Aísa Á, Fiorini G, Tepes B, Castro-Fernández M, Lucendo A, Voynovan I, Bujanda L, Garre A, Rodrigo L, Martínez Domínguez SJ, Denkovski M, Huguet Malavés JM, Jonaitis L, Bumane R, Zaytsev O, Mata Romero P, Barrio J, Fernández-Salazar L, Sarsenbaeva AS, Ortiz Polo I, Alekseenko S, Saracino IM, Vaira D, Keco-Huerga A, Bordin D, Gasbarrini A, Lerang F, Rokkas T, Kupčinskas J, Leja M, Babayeva G, Marcos Pinto R, Tonkić A, Smith S, Phull P, Buzas GM, Simsek H, Boltin D, Gridnyev O, Venerito M, Milivojevic V, Torà N, Cano-Català A, Moreira L, Nyssen OP, Mégraud F, O'Morain C, Gisbert JP, Puig I, and On Behalf Of Hp-EuReg Investigators
- Abstract
Background and Aims: Several methods are available to diagnose Helicobacter pylori infection. Our objective was to evaluate the tests used for both the initial diagnosis and the confirmation of eradication after treatment in Europe., Methods: The European Registry on the management of Helicobacter pylori infection is an international, multicentre, prospective, non-interventional registry aiming to evaluate the management of Helicobacter pylori -infected patients in Europe. Countries with at least 100 cases registered from June 2013 to April 2021, and with a validated diagnostic method were analysed. Data were quality reviewed., Results: A total of 34,920 adult patients from 20 countries were included (mean age 51 years; 61% women). To establish the initial diagnosis, invasive tests were performed in 19,801 (71%) patients, non-invasive in 11,369 (41%), and both in 3437 (12%). The most frequent were histology (n = 11,885; 43%), a rapid urease test (n = 10,636; 38%) and an urea breath test (n = 7577; 27%). According to the age, invasive tests were indicated in 11,179 (77%) ≥50 years, and in 8603 (65%) <50 years. Depending on the country, the use of invasive tests ranged from 29-99% in <50 years to 60-99% in ≥50. Most of the tests used to confirm eradication were non-invasive (n = 32,540; 93%), with the urea breath test being the most frequent (n = 32,540; 78%). In 2983 (9%) post-treatment tests, histology (n = 1887; 5%) or a rapid urease test (n = 1223; 4%) were performed., Conclusion: A great heterogeneity was observed for the initial diagnosis and confirmation of the eradication. The reasons for the apparent lack of adherence to the clinical guidelines should be further explored.
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- 2023
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34. International on-line questionnaire about severe lower gastrointestinal bleeding management: Do we have it clear?
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Ayude Galego M, Rodríguez González MM, Nogueira Sentíes D, Iglesias Doallo A, Fernández Fernández N, Alonso Lorenzo S, Gómez Rodríguez A, Quintáns Pinazas N, Romero Mosquera B, Germade Martínez A, Rodríguez de Jesús AJ, Vázquez Rodríguez S, Rodríguez Prada JI, and García Morales N
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- Humans, Computed Tomography Angiography, Tomography, X-Ray Computed, Gastrointestinal Hemorrhage diagnosis, Gastrointestinal Hemorrhage etiology, Gastrointestinal Hemorrhage therapy, Colonoscopy methods, Hospitalization
- Abstract
Background and Aims: The diagnostic and therapeutic strategy in severe lower gastrointestinal bleeding (LGIB) varies depending on the patient's clinical situation. Actual clinical practice guidelines propose different management strategies. We aim to know the attitude of the gastroenterologists from different hospitalary centers in the management of this entity., Methods: Descriptive and observational study using an on-line questionnaire, addressed to gastroenterologists in Spain and Latin America, in December 2021., Results: We included 281 anonymous questionnaires of gastroenterologists from Spain and Latin America. Diagnostic and therapeutic management of severe LGIB was heterogeneous among the participants. Regarding to the first diagnostic modalities they showed variability between performing computed tomography angiography (CTA) (44.5%), gastroscopy (33.1%), colonoscopy (20.6%) and arteriography (1.1%). The therapeutic attitude after a positive CTA mostly varied between performing arteriography (38.1%) and colonoscopy (44.1%). If negative CTA, in the majority of cases a gastroscopy was performed. If the patient needed intensive critical unit (ICU) care and to undergo colonoscopy, most participants performed an urgent colonoscopy (<24h) (31% always, 43.4% in most cases); while if the patient did not require ICU admission this percentage was lower (10% always, 33.8% in most cases). The 40.9% of the participants admitted having doubts about the management of this patients and the 98.2% considered the need for a creation of an action protocol., Conclusions: There is a high interhospitalary variability on the management of severe lower gastrointestinal bleeding among gastroenterologists. It is necessary to unify the diagnostic and therapeutic management of this pathology., (Copyright © 2022 Elsevier España, S.L.U. All rights reserved.)
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- 2023
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35. Perceived barriers and benefits in the participation in faecal occult blood test colorectal cancer screening programme.
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Menéndez Rodríguez M, García-Morales N, Seoane Pillado T, Garau Ramírez J, Traver Salvador A, Hervás Jiménez Y, Pin Vieito N, Menéndez Rodríguez L, and Cubiella J
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- Humans, Early Detection of Cancer, Mass Screening, Occult Blood, Colorectal Neoplasms epidemiology
- Abstract
Background: Colorectal cancer is the second cancer-related cause of death in the world. Tumour stage at diagnosis is the principal prognosis factor of survival. However, the participation in the programme is around 50%. The aim of the study was to identify the benefits and barriers perceived by the population when participating in a colorectal cancer screening programme with faecal occult blood test., Methods: We carried out a cases-controls study with 408 participants. We analyzed epidemiological and social variables associated with lifestyle and behavioural factors based in the Health Belief Model. We conducted a descriptive analysis, and identified variables associated to adherence by a logistic regression., Results: Variables independently associated with the participation in a colorectal cancer screening programme were age (OR 1.06; 95% CI: 1.01-1.11), having a stable partner (OR 1.96; 95% CI: 1.20-3.18), the level of education (OR 1.59; 95% CI: 1.02-2.47) and two of the barriers to participate in the faecal occult blood test screening: "you don't know how to do one" (OR=0.46; 95% CI: 0.23-0.93) and "it is not that important right now" (OR=0.43; 95% CI: 0.24-0.78)., Conclusion: The existing barriers for screening with faecal occult blood test are the best factor predicting. This is relevant when designing the intervention programmes, as they should focus on reducing perceived barriers to increase the participation in colorectal cancer screening, thereby reducing colorectal cancer mortality., (Copyright © 2022 Elsevier España, S.L.U. All rights reserved.)
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- 2023
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36. Differences between childhood- and adulthood-onset eosinophilic esophagitis: An analysis from the EoE connect registry.
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Laserna-Mendieta EJ, Navarro P, Casabona-Francés S, Savarino EV, Pérez-Martínez I, Guagnozzi D, Barrio J, Perello A, Guardiola-Arévalo A, Betoré-Glaria ME, Blas-Jhon L, Racca F, Krarup AL, Gutiérrez-Junquera C, Fernández-Fernández S, la Riva S, Naves JE, Carrión S, García-Morales N, Roales V, Rodríguez-Oballe JA, Dainese R, Rodríguez-Sánchez A, Masiques-Mas ML, Feo-Ortega S, Ghisa M, Maniero D, Suarez A, Llerena-Castro R, Gil-Simón P, de la Peña-Negro L, Granja-Navacerrada A, Alcedo J, Hurtado de Mendoza-Guena L, Pellegatta G, Pérez-Fernández MT, Santander C, Tamarit-Sebastián S, Arias Á, and Lucendo AJ
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- Humans, Cross-Sectional Studies, Delayed Diagnosis, Registries, Eosinophilic Esophagitis diagnosis, Deglutition Disorders diagnosis
- Abstract
Background: Direct comparisons of childhood- and adulthood-onset eosinophilic esophagitis (EoE) are scarce., Aim: To compare disease characteristics, endoscopic and histological features, allergic concomitances and therapeutic choices across ages., Methods: Cross-sectional analysis of the EoE CONNECT registry., Results: The adulthood-onset cohort (those diagnosed at ≥18y) comprised 1044 patients and the childhood-onset cohort (patients diagnosed at <18 y), 254. Vomiting, nausea, chest and abdominal pain, weight loss, slow eating and food aversion were significantly more frequent in children; dysphagia, food bolus impaction and heartburn predominated in adults. A family history of EoE was present in 16% of pediatric and 8.2% of adult patients (p<0.001). Concomitant atopic diseases did not vary across ages. Median±IQR diagnostic delay (years) from symptom onset was higher in adults (2.7 ± 6.1) than in children (1 ± 2.1; p<0.001). Esophageal strictures and rings predominated in adults (p<0.001), who underwent esophageal dilation more commonly (p = 0.011). Inflammatory EoE phenotypes were more common in children (p = 0.001), who also presented higher eosinophil counts in biopsies (p = 0.015) and EREFS scores (p = 0.017). Despite PPI predominating as initial therapy in all cohorts, dietary therapy and swallowed topical corticosteroids were more frequently prescribed in children (p<0.001)., Conclusions: Childhood-onset EoE has differential characteristics compared with adulthood-onset, but similar response to treatment., Competing Interests: Conflict of Interest AJ Lucendo has served as a speaker, and/or has received research and/or education funding and/or consulting fees from Adare/Ellodi, Dr. Falk Pharma, Regeneron, Dr. Falk Pharma and EsoCap. C. Santander received honoraria as consultant and trainer at Laborie/MMS and Medtronic Covidien AG, and received research funding from AstraZeneca, EsoCap Biotech, Regeneron Pharmaceuticals Inc., Adare Pharmaceuticals Inc., and Dr. Falk Pharma GmbH. J. Alcedo has served as a speaker, consultant and advisory member for or has received research funding from Adare Pharmaceuticals Inc, Abbvie, MSD, Allergan, and Shire Pharmaceuticals. C Gutiérrez-Junquera has received research funding from Dr. Falk Pharma. The remaining authors have no conflict of interest., (Copyright © 2022. Published by Elsevier Ltd.)
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- 2023
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37. Inadequate social support decreases survival in decompensated liver cirrhosis patients.
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García Morales N, Fernández de la Varga M, Pumares Pérez J, Menéndez Rodríguez M, Gutiérrez Morato S, Castillo Cejas C, Aguilera V, Benlloch S, Menéndez Rodríguez L, Seoane Pillado T, Pin Vieito N, and Cubiella J
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- Male, Humans, Middle Aged, Female, Cohort Studies, Prospective Studies, Prognosis, Severity of Illness Index, Liver Cirrhosis complications, Liver Neoplasms complications
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Introduction: Inadequate social support is associated with higher mortality both in the general population and in patients with chronic diseases. There are no studies that have described social support in liver cirrhosis and its impact on prognosis., Objectives: To analyze the impact social support has in the survival of patients with decompensated cirrhosis., Methods: Prospective multicentric cohort study (2016-2019). Patients with decompensated liver cirrhosis were included. Epidemiological, clinical and social variables were collected, using the validated Medical Outcomes Study Social Support Survey, with a 12-month follow-up., Results: A total of 127 patients were included, of which 79.5% were men. The most common etiology of cirrhosis was alcohol (74.8%), mean age was 60 years (SD 10.29), mean MELD was 15.6 (SD 6.3) and most of the patients had a Child-Pugh B (53.5%) or C (35.4%). In the assessment of social support, we observed that most of the patients (92.2%) had adequate global support. At the end of the follow-up (median 314 days), 70.1% of the patients survived. The 1-year survival rate in patients with inadequate global social support was 30%, compared to 73.5% in the presence of social support. In multivariate Cox regression analysis, inadequate social support predicted survival with an adjusted HR of 5.5 (95% CI 2,3-13,4) independently of MELD (HR 1.1, 95% CI 1-1.2), age (HR 1, 95% CI 1-1.1) and hepatocarcinoma (HR 10.6, 95% CI 4.1-27.4)., Conclusion: Adequate social support improves survival in liver cirrhosis, independently of clinical variables. Social intervention strategies should be considered for their management., (Copyright © 2022 Elsevier España, S.L.U. All rights reserved.)
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- 2023
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38. Accurate and timely diagnosis of Eosinophilic Esophagitis improves over time in Europe. An analysis of the EoE CONNECT Registry.
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Navarro P, Laserna-Mendieta EJ, Casabona S, Savarino E, Pérez-Fernández MT, Ghisa M, Pérez-Martínez I, Guagnozzi D, Perelló A, Guardiola-Arévalo A, Racca F, Betoré E, Blas-Jhon L, Krarup AL, Martín-Domínguez V, Maniero D, Suárez A, Llerena-Castro R, de la Peña-Negro L, Navacerrada AG, Pellegatta G, Alcedo J, de Hurtado Mendoza-Guena L, Feo-Ortega S, Barrio J, Gutiérrez-Junquera C, Fernández-Fernández S, De la Riva S, E Navés J, Carrión S, Ciriza de Los Ríos C, García-Morales N, Rodríguez-Oballe JA, Dainese R, Rodríguez-Sánchez A, Masiques-Mas ML, Palomeque MT, Santander C, Tamarit-Sebastián S, Arias Á, and Lucendo AJ
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- Cross-Sectional Studies, Delayed Diagnosis, Enteritis, Eosinophilia, Gastritis, Humans, Registries, Deglutition Disorders diagnosis, Deglutition Disorders etiology, Eosinophilic Esophagitis diagnosis
- Abstract
Background: Poor adherence to clinical practice guidelines for eosinophilic esophagitis (EoE) has been described and the diagnostic delay of the disease continues to be unacceptable in many settings., Objective: To analyze the impact of improved knowledge provided by the successive international clinical practice guidelines on reducing diagnostic delay and improving the diagnostic process for European patients with EoE., Methods: Cross-sectional analysis of the EoE CONNECT registry based on clinical practice. Time periods defined by the publication dates of four major sets of guidelines over 10 years were considered. Patients were grouped per time period according to date of symptom onset., Results: Data from 1,132 patients was analyzed and median (IQR) diagnostic delay in the whole series was 2.1 (0.7-6.2) years. This gradually decreased over time with subsequent release of new guidelines (p < 0.001), from 12.7 years up to 2007 to 0.7 years after 2017. The proportion of patients with stricturing of mixed phenotypes at the point of EoE diagnosis also decreased over time (41.3% vs. 16%; p < 0.001), as did EREFS scores. The fibrotic sub-score decreased from a median (IQR) of 2 (1-2) to 0 (0-1) when patients whose symptoms started up to 2007 and after 2017 were compared (p < 0.001). In parallel, symptoms measured with the Dysphagia Symptoms Score reduced significantly when patients with symptoms starting before 2007 and after 2012 were compared. A reduction in the number of endoscopies patients underwent before the one that achieved an EoE diagnosis, and the use of allergy testing as part of the diagnostic workout of EoE, also reduced significantly over time (p = 0.010 and p < 0.001, respectively)., Conclusion: The diagnostic work-up of EoE patients improved substantially over time at the European sites contributing to EoE CONNECT, with a dramatic reduction in diagnostic delay., (© 2022 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)
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- 2022
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39. EoE CONNECT, the European Registry of Clinical, Environmental, and Genetic Determinants in Eosinophilic Esophagitis: rationale, design, and study protocol of a large-scale epidemiological study in Europe.
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Lucendo AJ, Santander C, Savarino E, Guagnozzi D, Pérez-Martínez I, Perelló A, Guardiola-Arévalo A, Barrio J, Elena Betoré-Glaria M, Gutiérrez-Junquera C, Ciriza de Los Ríos C, Racca F, Fernández-Fernández S, Blas-Jhon L, Lund Krarup A, de la Riva S, Naves JE, Carrión S, Rodríguez Oballe JA, García-Morales N, Tamarit-Sebastián S, Navarro P, Arias Á, and Laserna-Mendieta EJ
- Abstract
Background: The growing prevalence of eosinophilic esophagitis (EoE) represents a considerable burden to patients and health care systems. Optimizing cost-effective management and identifying mechanisms for disease onset and progression are required. However, the paucity of large patient cohorts and heterogeneity of practice hinder the defining of optimal management of EoE., Methods: EoE CONNECT is an ongoing, prospective registry study initiated in 2016 and currently managed by EUREOS, the European Consortium for Eosinophilic Diseases of the Gastrointestinal Tract. Patients are managed and treated by their responsible specialists independently. Data recorded using a web-based system include demographic and clinical variables; patient allergies; environmental, intrapartum, and early life exposures; and family background. Symptoms are structurally assessed at every visit; endoscopic features and histological findings are recorded for each examination. Prospective treatment data are registered sequentially, with new sequences created each time a different treatment (active principle, formulation, or dose) is administered to a patient. EoE CONNECT database is actively monitored to ensure the highest data accuracy and the highest scientific and ethical standards., Results: EoE CONNECT is currently being conducted at 39 centers in Europe and enrolls patients of all ages with EoE. In its aim to increase knowledge, to date EoE CONNECT has provided evidence on the effectiveness of first- and second-line therapies for EoE in clinical practice, the ability of proton pump inhibitors to induce disease remission, and factors associated with improved response. Drug effects to reverse fibrous remodeling and endoscopic features of fibrosis in EoE have also been assessed., Conclusion: This prospective registry study will provide important information on the epidemiological and clinical aspects of EoE and evidence as to the real-world and long-term effectiveness and safety of therapy. These data will potentially be a vital benchmark for planning future EoE health care services in Europe., Competing Interests: Conflict of interest statement: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Alfredo J. Lucendo has served as a speaker, and/or has received research and/or education funding and/or consulting fees from Adare/Ellodi, Dr. Falk Pharma, Regeneron, and EsoCap. Cecilio Santander has received training and consultant fees from Laborie/MMS. The rest of the authors have no conflict of interest., (© The Author(s), 2022.)
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- 2022
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40. Rawl's questionnaire spanish validation for colorectal cancer screening with faecal occult blood testing.
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Menéndez Rodríguez M, Garau Ramírez J, Traver Salvador A, Hervás Jiménez Y, García Morales N, Seoane Pillado T, Pin Vieito N, Vega Villaamil P, Montes Martínez A, and Cubiella J
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- Age Factors, Aged, Case-Control Studies, Educational Status, Humans, Middle Aged, Sex Factors, Colorectal Neoplasms diagnosis, Language, Occult Blood, Translations
- Abstract
Introduction: Colorectal cancer 5-years-survival is 57%, partway due to a low rate of participation in screening programmes. Instruments analyzing causes of low adherence are needed., Objective: To evaluate the validity and internal consistency of the Spanish version of Rawl's Questionnaire for the screening of colorectal cancer by faecal occult blood testing., Type of Study: Questionnaire validation methodology., Location: Three Primary Care Centres in Valencia., Variables: Age, sex, civil status, educational level, social class, smoking, alcohol consumption, body mass index, personal and family history of cancer., Results: We analyzed 408 individuals (237 cases and 171 controls). Mean age was 59.45 years (SD 5.17). Internal consistency of all variables reached a Cronbach's alfa of 0.796. The Cronbach's alfa benefit dimension of the screening was 0.871 and for the barrier dimension of the screening it was 0.817. Intraclass correlation coefficients of the test-retest for the benefit dimension of the screening was 0.809 (CI 95% 0.606-0.913) and 0.499 (CI 95% 0.126-0.750) for the barrier dimension., Conclusion: The Spanish version of Rawl's Questionnaire is valid, reliable and reproducible, so we have this validated instrument with which to identify barriers and benefits in a colorectal screening programme in Spain., (Copyright © 2021 Elsevier España, S.L.U. All rights reserved.)
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- 2022
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41. Predictive Value of Carcinoembryonic Antigen in Symptomatic Patients without Colorectal Cancer: A Post-Hoc Analysis within the COLONPREDICT Cohort.
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Pin-Vieito N, Iglesias MJ, Remedios D, Álvarez-Sánchez V, Fernández-Bañares F, Boadas J, Martínez-Bauer E, Campo R, Bujanda L, Ferrández Á, Piñol V, Rodríguez-Alcalde D, Menéndez-Rodríguez M, García-Morales N, Pérez-Mosquera C, and Cubiella J
- Abstract
We aimed to assess the risk of cancer in patients with abdominal symptoms after a complete colonoscopy without colorectal cancer (CRC), according to the carcinoembryonic antigen (CEA) concentration, as well as its diagnostic accuracy. For this purpose, we performed a post-hoc analysis within a cohort of 1431 patients from the COLONPREDICT study, prospectively designed to assess the fecal immunochemical test accuracy in detecting CRC. Over 36.5 ± 8.4 months, cancer was detected in 115 (8%) patients. Patients with CEA values higher than 3 ng/mL revealed an increased risk of cancer (HR 2.0, 95% CI 1.3-3.1), CRC (HR 4.4, 95% CI 1.1-17.7) and non-gastrointestinal cancer (HR 1.7, 95% CI 1.0-2.8). A new malignancy was detected in 51 (3.6%) patients during the first year and three variables were independently associated: anemia (OR 2.8, 95% CI 1.3-5.8), rectal bleeding (OR 0.3, 95% CI 0.1-0.7) and CEA level >3 ng/mL (OR 3.4, 95% CI 1.7-7.1). However, CEA was increased only in 31.8% (95% CI, 16.4-52.7%) and 50% (95% CI, 25.4-74.6%) of patients with and without anemia, respectively, who would be diagnosed with cancer during the first year of follow-up. On the basis of this information, CEA should not be used to assist in the triage of patients presenting with lower bowel symptoms who have recently been ruled out a CRC.
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- 2020
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42. Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients.
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Iborra M, García-Morales N, Rubio S, Bertoletti F, Calvo M, Taxonera C, Boscá-Watts MM, Sierra M, Mancenido N, Beltrán B, Nantes Castillejo Ó, García-Planella E, Vera I, Alba C, Martí-Aguado D, Ballester MP, Cano-Sanz N, Pajares-Villarroya R, Cerrillo E, Cañada A, and Nos P
- Subjects
- Adult, Cohort Studies, Colitis, Ulcerative epidemiology, Female, Follow-Up Studies, Humans, Male, Medication Adherence, Middle Aged, Spain epidemiology, Treatment Outcome, Tumor Necrosis Factor-alpha antagonists & inhibitors, Anti-Inflammatory Agents therapeutic use, Antibodies, Monoclonal therapeutic use, Colitis, Ulcerative drug therapy
- Abstract
Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.
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- 2020
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43. A long-term prospective study of the efficacy and safety of endoscopic septotomy using the LigaSure® system for the treatment of Zenker's diverticulum.
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Pons-Beltrán V, García Morales N, Sáez-González E, Alonso N, Ponce M, Bustamante M, and Argüello L
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- Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Treatment Outcome, Electrosurgery adverse effects, Esophageal Sphincter, Upper surgery, Esophagoscopy adverse effects, Zenker Diverticulum surgery
- Abstract
Background and Objectives: endoscopic septotomy of the cricopharyngeal muscle (ESCM) is a technique used for the treatment of Zenker's diverticulum (ZD). The experience with computerized vascular sealing systems (LigaSure® type) is limited. The objective of this study was to evaluate the efficacy and safety of ESCM using LigaSure®., Methods: this was a long-term prospective study of 18 patients with ZD, who were referred to our hospital due to ESCM between 2010 and 2016. The severity of the symptoms was determined using the Dakkak-Bennett validated scale for dysphagia and the rest with numerical scales. The rates of relapse and retreatment were evaluated., Results: ESCM with LigaSure® was performed in 17 cases, one case was excluded due to technical difficulties. The median age was 72 years and regurgitation, dysphagia and respiratory symptoms were found in 100%, 89% and 56% of cases, respectively. The median size of the diverticulum was 28 mm (20-60 mm). The median time of the procedure was 35 minutes (25-45 minutes). There were four complications, two hemorrhages and two perforations. The median follow-up was 13 months (range: 12-82 months). Clinical improvements were observed for all symptoms and were maintained 12 months after treatment (p < 0.05). There was no relapse during follow-up in 13 patients. A complete section was not achieved and clinical relapse occurred after a median time of seven months that required retreatment in the remaining patients., Conclusions: ESCM with LigaSure® may be a safe and effective technique in long-term follow-up situations, with low rates of relapse.
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- 2019
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44. Non-guided self-learning program for high-proficiency optical diagnosis of diminutive and small colorectal lesions: A single-endoscopist pilot study.
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Bustamante-Balén M, Satorres C, Puchades L, Navarro B, García-Morales N, Alonso N, Ponce M, Argüello L, and Pons-Beltrán V
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- Aged, Clinical Competence, Colon diagnostic imaging, Colon pathology, Colonoscopy methods, Colorectal Neoplasms pathology, Female, Humans, Male, Middle Aged, Pilot Projects, Predictive Value of Tests, Program Evaluation, Prospective Studies, Rectum diagnostic imaging, Rectum pathology, Sensitivity and Specificity, Colonoscopy education, Colorectal Neoplasms diagnostic imaging, Early Detection of Cancer methods, Narrow Band Imaging methods, Self-Directed Learning as Topic
- Abstract
Background: The implementation of optical diagnosis (OD) of diminutive colorectal lesions in clinical practice has been hampered by differences in performance between community and academic settings. One possible cause is the lack of a standardized learning tool. Since the factors related to better learning are not well described, strong evidence upon which a consistent learning tool could be designed is lacking. We hypothesized that a self-designed learning program may be enough to achieve competency in OD of diminutive lesions of the colon., Aim: To assess the accuracy of OD of diminutive lesions in real colonoscopies after application of a self-administered learning program., Methods: This was a single-endoscopist prospective pilot study, in which an experienced endoscopist followed a self-designed, self-administered learning program in OD of colorectal lesions. An assessment phase divided in two halves with a 6-mo period in between without performance of OD was developed in a population-based colorectal cancer screening program. The accomplishment of the Preservation and Incorporation of Valuable Endoscopic Innovations criteria and performance measures were calculated overall and in the two halves of the assessment phase, assessing their response to the 6-mo stopping period. The evolution of performance through blocks of 50 lesions was also assessed., Results: Overall, 152 patients and 522 lesions (≤ 5 mm: 399, and 6-9 mm: 123) were included. The negative predictive value for the OD of adenoma in rectosigmoid lesions diagnosed with high confidence was 91.7% [95% confidence interval (CI): 87.3-96.6]. The proportion of agreement on surveillance interval between OD and pathological diagnosis was higher than 95%. Overall accuracy for diminutive lesions diagnosed with high confidence was 89.5% (95%CI: 86.3-92.7). The overall accuracy of OD was similar in the two halves of the assessment phase [90.1 (95%CI: 85.6-94.7) vs 88.2 (95%CI: 87.9-95.9)]. All the other performance parameters were also equivalent, except for specificity. Specificity, negative predictive value and accuracy were the parameters most affected by the stopping period between the two halves. Upon analyzing trends on blocks of 50 lesions, an improvement on sensitivity ( P = 0.02) was detected only in the first half and an improvement on accuracy ( P = 0.01) was detected only in the second half., Conclusion: A self-administered learning program is sufficient to achieve expert-level OD. To maintain performance, continuous practice is needed, with a refresher course following any long non-practice period., Competing Interests: Conflict-of-interest statement: The authors have no conflicts of interest to declare.
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- 2019
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45. Intestinal tuberculosis simulating Crohn's disease: Differential diagnosis.
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García-Morales N, García-Campos M, Cordón G, and Iborra M
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- Adult, Antitubercular Agents therapeutic use, Colitis diagnostic imaging, Colitis drug therapy, Colonoscopy, Diagnosis, Differential, Humans, Ileitis diagnostic imaging, Ileitis drug therapy, Male, Tuberculoma diagnosis, Tuberculoma diagnostic imaging, Tuberculoma drug therapy, Tuberculosis, Gastrointestinal diagnostic imaging, Tuberculosis, Gastrointestinal drug therapy, Tuberculosis, Pulmonary complications, Colitis diagnosis, Crohn Disease diagnosis, Ileitis diagnosis, Tuberculosis, Gastrointestinal diagnosis
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- 2019
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46. Vedolizumab, an option in patients with inflammatory bowel disease intolerant to thiopurines and refractory to biological agents.
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Iborra M, Beltrán B, Maroto N, Navarro-Cortés P, Boscá-Watts M, Ferrer-Bradley I, García-Morales N, Sáez-González E, Hinojosa J, Mínguez M, and Nos P
- Subjects
- Adrenal Cortex Hormones therapeutic use, Adult, Antibodies, Monoclonal, Humanized adverse effects, Biological Factors therapeutic use, C-Reactive Protein analysis, Colectomy, Combined Modality Therapy, Drug Resistance, Feces chemistry, Female, Gastrointestinal Agents adverse effects, Hospitalization, Humans, Immunologic Factors therapeutic use, Inflammatory Bowel Diseases surgery, Leukocyte L1 Antigen Complex analysis, Male, Middle Aged, Treatment Outcome, Ustekinumab therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Gastrointestinal Agents therapeutic use, Inflammatory Bowel Diseases drug therapy
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Vedolizumab (VDZ), a human monoclonal antibody that binds specifically to α4β7-integrin, and is approved for the treatment of Crohn's disease (CD) and ulcerative colitis (UC), has demonstrated its efficacy in controlled clinical trials., Objective: To describe a population treated with VDZ and to evaluate its long-term efficacy and safety in clinical practice., Methods: An observational and multicentre study was carried out on patients with inflammatory bowel disease treated with VDZ for at least one year. An evaluation was performed on the activity indices, faecal calprotectin and C-reactive protein levels, hospital admissions, surgeries, and adverse events., Results: A total of 73 patients were analysed (43 UC and 30 CD). More than one anti-TNF and more than one immunosuppressive was previously used by 74 and 23%, respectively, of UC patients, and 90 and 37%, respectively of CD patients. VDZ was stopped in 17 (23%) patients, 10 UC and 7 CD, due to a lack or loss of response before the first year, or due to adverse events. An intensification of the dose was required in 26 (63%) UC, and 16 (53%) CD patients. At 6 months, 70 and 42% of UC patients, and 80 and 43% of CD patients achieved a clinical response and remission, respectively. At one year, 58 and 35% of UC patients and 47 and 43% of CD patients, maintained the clinical response and remission, respectively. The C-reactive protein decreased significantly in both CD and UC patients. However, the decrease in faecal calprotectin was only achieved during follow-up in UC, but not in CD patients. Eight patients with CD that had been treated previously with ustekinumab avoided surgery at one year. A colectomy was performed on 8 (18.6%) UC patients, and 4 (13.3%) CD patients needed surgery. Six patients (8%) (5 UC and 1 CD) had adverse events. The concomitant use of corticosteroids or immunomodulators did not increase the efficacy. Those with a higher number of previous anti-TNF treatments showed less remissions in UC and responses in CD., Conclusions: After one year of VDZ, a clinical response and remission was induced in a considerable percentage of patients refractory to different biological or immunosuppressive therapies. VDZ can be considered as an alternative in those intolerant to immunosuppressives, with few adverse events., (Copyright © 2018 Elsevier España, S.L.U. All rights reserved.)
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- 2018
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47. Calcium and vitamin D in the serrated neoplastic pathway: Friends or foes?
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García-Morales N, Satorres C, and Bustamante-Balén M
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Sessile serrated adenoma/polyps (known as SSA/Ps) may play an important role in the development of interval colorectal cancer (CRC). These lesions are more difficult to detect with conventional endoscopy and they may quickly turn into CRC, especially when dysplasia has developed. Therefore, primary or secondary chemoprevention may be an appealing strategy at a population level. Calcium and vitamin D have been shown in epidemiological studies to reduce the risk of CRC and conventional adenomas, but the evidence regarding their effect on SSA/Ps is controversial. In this editorial we comment on the results of a recent randomized controlled trial investigating the effect of calcium and vitamin D on the development of serrated lesions, summarizing the possible antineoplastic mechanisms of calcium and vitamin D, and discussing the differences found with previous observational reports., Competing Interests: Conflict-of-interest statement: The authors have no conflicts of interest to declare.
- Published
- 2018
- Full Text
- View/download PDF
48. Sprue-like enterophaty asscociated with valsartan.
- Author
-
Del Val A, García Campos M, and García Morales N
- Subjects
- Aged, Humans, Male, Antihypertensive Agents adverse effects, Celiac Disease chemically induced, Valsartan adverse effects
- Published
- 2018
- Full Text
- View/download PDF
49. Opioid-induced functional esophagogastric junction obstruction.
- Author
-
Sáez-González E, Díaz-Jaime FC, García-Morales N, Herreras-López J, Ortiz V, Ortuño J, and Garrigues V
- Subjects
- Analgesics, Opioid administration & dosage, Analgesics, Opioid therapeutic use, Buprenorphine administration & dosage, Buprenorphine therapeutic use, Deglutition Disorders etiology, Female, Humans, Low Back Pain drug therapy, Manometry, Middle Aged, Transdermal Patch, Analgesics, Opioid adverse effects, Buprenorphine adverse effects, Esophageal Spasm, Diffuse chemically induced, Esophageal Sphincter, Lower drug effects
- Published
- 2017
- Full Text
- View/download PDF
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