RESUMEN
This study aimed to validate the Yale Pharyngeal Residue Severity Rating Scale's European Portuguese version and investigate the impact of rater experience. The scale measures the severity of residue in the vallecula and pyriform sinus. Ninety Fiberoptic Endoscopic Evaluation of Swallowing images were selected after consensus and proposed to 13 raters who were asked to assess the severity of pharyngeal residue (PR) in each image in two moments with an interval of two weeks. The raters were divided by years of experience conducting the Fiberoptic Endoscopic Evaluation of Swallowing and in experience using severity scales for residues. Construct validity, inter-rater, and intra-rater reliability were assessed by kappa statistics. The original English scale was translated into European Portuguese using a forward-backward method for validation. The scale reliability was strong, with an elevated intra-rater internal consistency for vallecula (Cronbach's alpha = 0.982) and pyriform sinus (Cronbach's alpha = 0.922). Inter-rater reliability for raters was equally significant and high for vallecula (0.613 for first assessment and 0.604 for second assessment) and pyriform sinus (0.558 for first assessment and 0.509 for second assessment) or for raters with experience using Yale Pharyngeal Severity Rating Scale (vallecula with 0.832 for first assessment and 0.717 for second assessment and pyriform sinus with 0.856 for first assessment and 0.714 for second assessment).The European Portuguese version of the Yale Pharyngeal Severity Rating Scale is a valid, reliable instrument for scoring the location and severity of pharyngeal residue in the context of fiberoptic endoscopic evaluation of swallowing.
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A 68-year-old overweight woman with no history of oral contraceptive use presented a large liver mass of 40 cm on abdominal ultrasound without associated symptoms. Complete blood count, coagulation study, and liver biochemistry were unremarkable. Abdominal contrast-enhanced CT revealed a 33x24 cm lesion with discontinuous peripheral globular uptake and centripetal fill-in, consistent with an extremely giant hemangioma. It affected all segments of the right lobe, compressing the right suprahepatic vein and displacing all intra-abdominal structures, with a deviation of the midline structures (stomach and pancreas) to the left. Given the hemangioma size and its significant mass effect, surgery was discussed but declined by the patient, who remains asymptomatic 3 years later. Extremely giant liver hemangiomas (>10 cm) are rare, and the approach to asymptomatic patients is debated. Some advocate for prophylactic excision due to the potential for internal bleeding, growth, or rupture, while others suggest intervention for hemangiomas near major vascular structures. The American College of Gastroenterology recommends surgical intervention in such cases, but the European Association for the Study of the Liver suggests a conservative approach for most patients. This case highlights a successful "watch-and-wait" strategy, bringing attention to this unusual condition and its controversial management.
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A 70-year-old man with a cholangiocarcinoma underwent a cephalic duodenopancreatectomy. On the 2nd postoperative day, he had hematemesis without hemodynamic instability. Upper endoscopy (EGD) revealed a massive clot at the pancreatic stump, suspected as the source of hemorrhage. After partial clot removal, no active bleeding was found and no therapy was performed. Pancreaticogastric and gastrojejunal anastomoses, as well as the efferent-limb, showed no suspicious lesions. Octreotide was initiated and heparin prophylaxis was temporarily stopped. Bleeding from pancreatic stump following pancreatoduodenectomy is a rare but a life-threatening condition. Conventional endoscopic therapies, including clip placement and cautery, are mostly ineffective and with high risk of pancreatitis. We report the second case of hemostatic powder as a safe and successful therapy in this scenario.
Asunto(s)
Hemostáticos , Pancreatitis , Masculino , Humanos , Anciano , Pancreaticoduodenectomía/efectos adversos , Hemostáticos/uso terapéutico , Páncreas/cirugía , Hematemesis , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/terapiaRESUMEN
Tofacitinib is an oral small molecule JAK inhibitor approved for the treatment of moderate to severe ulcerative colitis (UC). Its efficacy and safety have been demonstrated in phase III clinical trials and supported by real-life data. We report the case of an 18-year-old woman with a 1-year diagnosis of left-sided UC, with multiple admissions due to disease exacerbation or infections, refractory to infliximab (with azathioprine) and currently under treatment with vedolizumab and tacrolimus. She was admitted due to a severe disease exacerbation and, because of a previous history of neuropsychiatric side effects to corticotherapy, tofacitinib was initiated. In the following 6 days, there was no clinical improvement of UC, and serial blood work-up revealed moderate grade persistent peripheral eosinophilia (3000 cells/mm3) and acute kidney injury grade 1 KDIGO. Tofacitinib temporary suspension was decided, with a rapid normalization of renal function/eosinophil levels. Tofacitinib was restarted 2 days after its suspension. However, she developed moderate eosinophilia (2000 cells/mm3) again, which was considered an adverse effect (AE) to tofacitinib, leading to its suspension with eosinophilia resolution. Given the severity of the disease, after a multidisciplinary discussion, it was decided to start high-dose corticotherapy and ustekinumab with maintenance therapy every 4 weeks, and to add tacrolimus. Clinical and biochemical remission were achieved, and the patient was discharged. Three-month follow-up after tofacitinib suspension showed no recrudescence of eosinophilia. Tofacitinib represents a significant advance in the management of UC patients. The drug has a good safety profile with few related AE. This case aims to warn about an adverse reaction to tofacitinib not reported so far, including in a multicenter real-life setting recently published by Hernández et al where eosinophilia is also not described, thus emphasizing the rarity of this AE. To our knowledge this is the first case of tofacitinib-induced eosinophilia in the context of UC. .
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Colitis Ulcerosa , Eosinofilia , Femenino , Humanos , Adolescente , Tacrolimus/uso terapéutico , Resultado del Tratamiento , Colitis Ulcerosa/tratamiento farmacológico , Eosinofilia/inducido químicamente , Progresión de la EnfermedadRESUMEN
BACKGROUND: Rubber band ligation and sclerotherapy are considered the office-based procedures of choice in hemorrhoidal disease. However, there are no studies comparing rubber band ligation and polidocanol foam sclerotherapy. OBJECTIVE: We aimed to evaluate the efficacy and safety of polidocanol foam sclerotherapy compared with rubber band ligation. DESIGN: This study was a randomized open-label study with 1-year follow-up. SETTINGS: The study was conducted in the colorectal unit of a tertiary hospital. PATIENTS: One hundred twenty patients with hemorrhoidal disease grades I to III were included. INTERVENTIONS: Patients were stratified by hemorrhoidal disease grade and randomly assigned (1:1) to treatment with either rubber band ligation (n = 60) or polidocanol foam sclerotherapy (n = 60). MAIN OUTCOME MEASURES: Efficacy outcomes included therapeutic success and recurrence. Safety outcomes included the occurrence of complications related to the procedures. RESULTS: Therapeutic success was not significantly different between the groups (polidocanol foam sclerotherapy 93.3% vs rubber band ligation 85.0%, p = 0.14). However, complete success rate was higher in the polidocanol foam sclerotherapy group (88.3% vs 66.7%, p = 0.009) with fewer office-based sessions (mean ± SD: 1.32 ± 0.60 vs 1.62 ± 0.76, p = 0.02). Recurrence rates were lower in the polidocanol foam sclerotherapy group (16.1% vs 41.2%, p = 0.004). Most recurrences were mild (83.3%). Complications were more frequent in the rubber band ligation group (30.0% vs 10.0%, p = 0.01) and were mostly minor (91.7%). No severe complications were observed in either group. LIMITATIONS: This study was performed in a single center, and both patients and investigators were not blinded to the treatment group. CONCLUSIONS: Both procedures are effective in the treatment of hemorrhoidal disease grades I to III. Polidocanol foam sclerotherapy was more effective than rubber band ligation when considering complete success. Patients in the polidocanol foam sclerotherapy group needed fewer treatment sessions, had lower recurrence rates, and were less likely to have complications. See Video Abstract at http://links.lww.com/DCR/B816. REGISTRATION: https//www.clinicaltrials.gov; Identifier: NCT04091763. ESCLEROTERAPIA CON ESPUMA DE POLIDOCANOL VERSUS LIGADURA CON BANDA DE GOMA EN LOS GRADOS I / II / III DE ENFERMEDAD HEMORROIDAL ENSAYO ALEATORIZADO: ANTECEDENTES:La ligadura con banda elástica y la escleroterapia se consideran los procedimientos de elección en el consultorio para la enfermedad hemorroidal. Sin embargo, no hay estudios que comparen la ligadura con bandas elastica y la escleroterapia con espuma de polidocanol.OBJETIVO:Nuestro objetivo fue evaluar la eficacia y seguridad de la escleroterapia con espuma de polidocanol en comparación con la ligadura con bandas elastica.DISEÑO:Estudio aleatorizado randomizado, abierto, con seguimiento de 1 año.AJUSTES:El estudio se realizó en una unidad colorrectal de un hospital terciario.PACIENTES:Se incluyeron 120 pacientes con enfermedad hemorroidal grados I a III.INTERVENCIONES:Los pacientes fueron estratificados por grado de enfermedad hemorroidal y asignados al azar (1: 1) al tratamiento con ligadura con banda elastica (n = 60) o escleroterapia con espuma de polidocanol (n = 60).PRINCIPALES MEDIDAS DE RESULTADO:Los resultados de eficacia incluyeron el éxito terapéutico y la recurrencia. Los resultados de seguridad incluyeron la aparición de complicaciones relacionadas con los procedimientos.RESULTADOS:El éxito terapéutico no fue significativamente diferente entre los grupos (escleroterapia con espuma de polidocanol 93,3% vs ligadura con banda de goma 85,0%, p = 0,14). Sin embargo, la tasa de éxito completo fue mayor en el grupo de escleroterapia con espuma de polidocanol (88,3% vs 66,7%, p = 0,009), con menos sesiones en el consultorio (media ± desviación estándar: 1,32 ± 0,60 vs 1,62 ± 0,76, p = 0,02). Las tasas de recurrencia fueron más bajas en el grupo de escleroterapia con espuma de polidocanol (16,1% vs 41,2%, p = 0,004). La mayoría de las recurrencias fueron leves (83,3%). Las complicaciones fueron más frecuentes en el grupo de ligadura con bandas elastica (30,0% vs 10,0%, p = 0,01) y fueron en su mayoría menores (91,7%). No se observaron complicaciones graves en ninguno de los grupos.LIMITACIONES:Este estudio se realizó en un solo centro y ni los pacientes ni los investigadores estaban cegados al grupo de tratamiento.CONCLUSIONES:Ambos procedimientos son efectivos en el tratamiento de la enfermedad hemorroidal grados I a III. La escleroterapia con espuma de polidocanol fue más eficaz que la ligadura con banda de goma cuando se consideró el éxito completo. Los pacientes del grupo de escleroterapia con espuma de polidocanol necesitaron menos sesiones de tratamiento, tuvieron tasas de recurrencia más bajas y menos probabilidades de tener complicaciones. Consulte Video Resumen en http://links.lww.com/DCR/B816. (Traducción-Dr Yolanda Colorado)ClinicalTrials.gov, número NCT04091763.
Asunto(s)
Hemorroides , Escleroterapia , Hemorroides/terapia , Humanos , Ligadura/efectos adversos , Ligadura/métodos , Polidocanol/uso terapéutico , Estudios Retrospectivos , Escleroterapia/efectos adversos , Escleroterapia/métodosRESUMEN
A 55-year-old male underwent endoscopic submucosal dissection (ESD), under general anesthesia and orotracheal intubation, of a 22 mm Paris 0-IIa+0-IIb lesion located in the greater curvature of the medium/distal antrum. It was not possible to start the procedure after several attempts due to permanent belching and inability to maintain adequate gastric distension. ESD was only feasible after performing the Sellick maneuver (manual pressure application at the cricoid cartilage to occlude the upper esophagus), which allowed sustained gastric distension throughout the procedure (60 minutes).
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Resección Endoscópica de la Mucosa , Dilatación Gástrica , Neoplasias Gástricas , Masculino , Humanos , Persona de Mediana Edad , Resección Endoscópica de la Mucosa/métodos , Neoplasias Gástricas/patología , Mucosa Gástrica/patologíaRESUMEN
Mucosal T lymphocytes from patients with ulcerative colitis (UC) were previously shown to display a deficiency in branched N-glycosylation associated with disease severity. However, whether this glycosylation pathway shapes the course of the T cell response constituting a targeted-specific mechanism in UC remains largely unknown. In this study, we demonstrated that metabolic supplementation of ex vivo mucosal T cells from patients with active UC with N-acetylglucosamine (GlcNAc) resulted in enhancement of branched N-glycosylation in the T cell receptor (TCR), leading to suppression of T cell growth, inhibition of the T helper 1 (Th1)/Th17 immune response, and controlled T cell activity. We further demonstrated that mouse models displaying a deficiency in the branched N-glycosylation pathway (MGAT5-/-, MGAT5+/-) exhibited increased susceptibility to severe forms of colitis and early-onset disease. Importantly, the treatment of these mice with GlcNAc reduced disease severity and suppressed disease progression due to a controlled T cell-mediated immune response at the intestinal mucosa. In conclusion, our human ex vivo and preclinical results demonstrate the targeted-specific immunomodulatory properties of this simple glycan, proposing a therapeutic approach for patients with UC.
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Acetilglucosamina/farmacología , Linfocitos T CD4-Positivos/inmunología , Colitis Ulcerosa/inmunología , N-Acetilglucosaminiltransferasas/fisiología , Polisacáridos/metabolismo , Inmunidad Adaptativa , Animales , Linfocitos T CD4-Positivos/efectos de los fármacos , Linfocitos T CD4-Positivos/metabolismo , Estudios de Casos y Controles , Colitis Ulcerosa/inducido químicamente , Colitis Ulcerosa/tratamiento farmacológico , Colitis Ulcerosa/metabolismo , Citocinas/metabolismo , Glicosilación , Humanos , Activación de Linfocitos , Ratones , Ratones Endogámicos C57BL , Ratones Noqueados , Receptores de Antígenos de Linfocitos T/metabolismoRESUMEN
Inflammatory Bowel Disease and Psoriasis are chronic inflammatory diseases that share common genotype, clinical course, and immunological features, although its relationship is still unclear. We report a 34-year-old woman with ileal Crohn's disease diagnosed 14 years ago, with the development of extensive, exudative scalp lesions after adalimumab therapy. Biopsies from skin lesions were compatible with vulgar psoriasis. The patient reports no personal or family history of psoriasis. Due to persistence and further worsening of skin lesions, paradoxical etiology to adalimumab was presumed and the drug was stopped with complete resolution of skin lesions and intestinal disease in remission under methotrexate. Due to pregnancy-planification methotrexate was stopped and, 8 months-after, systemic steroid-therapy was introduced due to moderate-to-severe intestinal flare. Vedolizumab was started and at the second infusion patient reported hair loss with no other complaints. Twelve months after vedolizumab initiation the patient reported reappearance of the extensive scalp and peri-fistula psoriatic lesions. Topical therapy was started but unsuccessfully and given the progressive worsening of the lesions, vedolizumab was suspended, with skin improvement seen 1 month after discontinuation. There are few case-reports of vedolizumab acting as a trigger to some dermatological conditions in IBD-patients, including psoriasis. The molecular mechanism behind it isn't fully understood. We present and discuss, to our knowledge, the first case in the literature of psoriasis triggered by vedolizumab in Crohn's disease.
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Enfermedad de Crohn , Psoriasis , Adalimumab , Adulto , Anticuerpos Monoclonales Humanizados/efectos adversos , Enfermedad de Crohn/tratamiento farmacológico , Femenino , Humanos , Psoriasis/inducido químicamente , Psoriasis/tratamiento farmacológicoRESUMEN
BACKGROUND: rectal cancer staging using rigid probes or echoendoscopes has some limitations. The aim of the study was to compare rectal cancer preoperative staging using conventional endoluminal ultrasonography with three-dimensional endoscopic ultrasonography and miniprobes. MATERIALS AND METHODS: sixty patients were included and evaluated with: a) a conventional echoendoscope (7.5 and 12 MHz); b) miniprobes (12 MHz); and c) the Easy 3D Freescan software for three-dimensional endoscopic ultrasonography. The reference or gold standard was conventional endoluminal ultrasonography in all cases and pathological assessment for those without preoperative therapy. The differences in T and N staging accuracy in both longitudinal and circumferential extension were evaluated. RESULTS: with regard to T staging, conventional endoluminal ultrasonography had an accuracy of 85% (compared to pathological analysis), and the agreement between miniprobes vs conventional endoluminal ultrasonography (kappa = 0.81) and three-dimensional endoscopic ultrasonography vs conventional endoluminal ultrasonography (k = 0.87) was significant. In addition, miniprobes had an accuracy of 82% and three-dimensional endoscopic ultrasonography had a higher accuracy (96%). With regard to N staging, conventional endoluminal ultrasonography had an accuracy of 91% with a sensitivity of 78%. However, the agreement between miniprobes and conventional endoluminal ultrasonography and three-dimensional endoscopic ultrasonography and conventional endoluminal ultrasonography (k = 0.70) was lower. Interestingly, miniprobes had a lower accuracy of 81% whereas three-dimensional endoscopic ultrasonography had an accuracy of 100% without any false negative. No false positives were observed in any of the techniques. Accuracy for T and N staging was not influenced by longitudinal or circumferential extensions of the tumor in all types of endoscopic ultrasonography analyzed. CONCLUSIONS: miniprobes and especially three-dimensional endoscopic ultrasonography may be relevant during rectal cancer staging.
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Endosonografía/métodos , Imagenología Tridimensional , Cuidados Preoperatorios/métodos , Neoplasias del Recto/diagnóstico por imagen , Neoplasias del Recto/patología , Adulto , Anciano , Anciano de 80 o más Años , Endosonografía/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Cuidados Preoperatorios/instrumentación , Estudios Prospectivos , Neoplasias del Recto/cirugía , Sensibilidad y EspecificidadAsunto(s)
Resección Endoscópica de la Mucosa , Humanos , Tracción , Colon , Instrumentos QuirúrgicosRESUMEN
BACKGROUND: Nonvariceal upper gastrointestinal bleeding emerges as a major complication of using antiplatelet agents and/or anticoagulants and represents a clinical challenge in patients undergoing these therapies. AIM: To characterize patients with nonvariceal upper gastrointestinal bleeding related to antithrombotics and their management, and to determine clinical predictors of adverse outcomes. METHODS: Retrospective cohort of adults who underwent upper gastrointestinal endoscopy after nonvariceal upper gastrointestinal bleeding from 2010 to 2012. The outcomes were compared between patients exposed and not exposed to antithrombotics. RESULTS: Five hundred and forty-eight patients with nonvariceal upper gastrointestinal bleeding (67% men; mean age 66.5 ± 16.4 years) were included, of which 43% received antithrombotics. Most patients had comorbidities. Peptic ulcer was the main diagnosis and endoscopic therapy was performed in 46% of cases. The 30-day mortality rate was 7.7% (n = 42), and 36% were bleeding-related. The recurrence rate was 9% and 14% of patients with initial endoscopic treatment needed endoscopic retreatment. There were no significant differences between the exposed and non-exposed groups in most outcomes. Co-morbidities, hemodynamic instability, high Rockall score, low hemoglobin (7.76 ± 2.72 g/dL) and higher international normalized ratio (1.63 ± 1.13) were associated significantly with mortality in a univariate analysis. CONCLUSIONS: Adverse outcomes were not associated with antithrombotic use. The management of nonvariceal upper gastrointestinal bleeding constitutes a challenge to clinical performance optimization and clinical cooperation.
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Anticoagulantes/efectos adversos , Hemorragia Gastrointestinal/inducido químicamente , Inhibidores de Agregación Plaquetaria/efectos adversos , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoAsunto(s)
Antivirales , Hepatitis C Crónica , Estudios de Seguimiento , Humanos , Portugal , Respuesta Virológica SostenidaRESUMEN
BACKGROUND: Most countries lack a well-coordinated approach to out-of-hours endoscopy. Economic constraints and lack of resources have been identified as important barriers. OBJECTIVE: To assess the performance evaluation of an out-of-hours emergency endoscopy model of care. DESIGN: During a 3 year period (January 2010 to December 2012), data from consecutive outpatients (n = 332) with non-variceal acute upper gastrointestinal bleeding admitted or transferred to a single referral hospital were prospectively collected. RESULTS: 34% (n = 113) were direct admissions whereas 66% (n = 219) were transferred from other hospitals. Median time to upper endoscopy esophagogastroduodenoscopy (EGD) was 6 h and 7.7 h for direct admissions and transferred, respectively. EGD was performed within 24 h in 90% of the patients. Rebleeding, in-hospital mortality, 30 day mortality and need for surgery were respectively 9.8%, 5.8%, 7.4%, and 6.6% and were not significantly different between the two groups. Age, malignancy, and moderate to high clinical Rockall risk score were independent predictors of in-hospital mortality in both groups. Age remained as an important predictor of main outcomes in transferred patients, while comorbidities differed according to admission status and predictable outcomes. CONCLUSION: This gastroenterology emergency model improved access and equity to out-of-hours endoscopy in an effective, safe, and timely way, recognized by the rates and the homogeneity observed in the outcomes, between transferred patients and direct admissions.
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Atención Posterior/normas , Endoscopía Gastrointestinal/normas , Hemorragia Gastrointestinal/etiología , Neoplasias/complicaciones , Adulto , Atención Posterior/organización & administración , Factores de Edad , Anciano , Anciano de 80 o más Años , Femenino , Hemorragia Gastrointestinal/cirugía , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Modelos Organizacionales , Neoplasias/diagnóstico , Evaluación de Procesos y Resultados en Atención de Salud , Admisión del Paciente/estadística & datos numéricos , Transferencia de Pacientes/estadística & datos numéricos , Recurrencia , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Adulto JovenRESUMEN
PURPOSE: To characterize colon and rectum walls, pericolic and perirectal spaces, using endoscopic ultrasonography miniprobes. METHODS: Sixty individuals (50% males), aged 18-80, were included. Using 12 and 20 MHz endoscopic ultrasonography miniprobes, all different colon segments (ascending, transverse, descending, sigmoid) and rectum were evaluated according to the number and thickness of the different layers in intestinal wall, to the presence and (largest) diameter of vessels in the submucosa and of peri-intestinal nodes. RESULTS: The 20 MHz miniprobe identified a higher number of layers than the 12 MHz miniprobe, with medians of 7 and 5 respectively (p < 0.001). The rectal wall (p = 0.001), its muscularis propria (p < 0.001) and mucosa (p = 0.01) were significantly thicker than the different segments of the colon, which had no significant differences between them. Patients aged 41-60 presented thicker colonic wall and muscularis propria in descending (p = 0.001 and p = 0.004) and rectum (p = 0.01 and p = 0.01). Submucosal vessels were identified in 30% of individuals in descending and rectum, and in 12% in ascending. Adenopathies were observed in 9% of the colon segments and 5% in rectum. CONCLUSIONS: A higher frequency enabled the identification of a higher number of layers. Rectal wall is thicker than the one from all the segments of the colon and there are no differences between these, namely in the ascending colon. Moreover, periintestinal adenopathies were rarely identified but present in asymptomatic individuals. All together, these results describe for the first time features which are relevant during staging and therapeutic management of colonic lesions.
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Colon/diagnóstico por imagen , Colonoscopía , Endosonografía , Mucosa Intestinal/diagnóstico por imagen , Recto/diagnóstico por imagen , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Colonoscopía/instrumentación , Colonoscopía/métodos , Endosonografía/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana EdadAsunto(s)
Neuropatías Amiloides Familiares , Gastroparesia , Miotomía/métodos , Cirugía Endoscópica por Orificios Naturales/métodos , Estómago , Adulto , Neuropatías Amiloides Familiares/diagnóstico , Neuropatías Amiloides Familiares/fisiopatología , Neuropatías Amiloides Familiares/cirugía , Vaciamiento Gástrico , Gastroparesia/diagnóstico , Gastroparesia/etiología , Gastroparesia/fisiopatología , Gastroparesia/cirugía , Humanos , Masculino , Estómago/diagnóstico por imagen , Estómago/cirugía , Resultado del TratamientoRESUMEN
INTRODUCTION: Information about pan-genotypic treatments for hepatitis in Portugal is scarce. We aimed to evaluate the effectiveness and safety of glecaprevir plus pibrentasvir (GLE/PIB) treatment for hepatitis C virus (HCV) infection in real-world clinical practice. METHODS: An observational prospective study was implemented in six hospitals with 121 adult HCV patients who initiated treatment with GLE/PIB between October 2018 and April 2019, according to clinical practice. Eligible patients had confirmed HCV infection genotype (GT) 1 to 6 and were either treatment-naïve or had experience with interferon-, ribavirin- or sofosbuvir-based regimens, with or without compensated cirrhosis. Baseline sociodemographic and safety data are described for the total population (N = 115). Effectiveness [sustained virologic response 12 weeks after treatment (SVR12)] and patient-reported outcomes are presented for the core population with sufficient follow-up data (n = 97). RESULTS: Most patients were male (83.5%), aged < 65 years (94.8%), with current or former alcohol consumption (77.3%), illicit drug use (72.6%), and HCV acquisition through intravenous drug use (62.0%). HIV co-infection occurred in 22.6% of patients. The prevalence of each GT was: GT1 51.3%, GT2 1.7%, GT3 30.4%, GT4 16.5%, and GT5.6 0%. Most patients were non-cirrhotic (80.9%) and treatment-naïve (93.8%). The SVR12 rates were 97.9% (95% CI: 92.8 - 99.4), and > 95% across cirrhosis status, GT, illicit drug use, alcohol consumption, and HCV treatment experience. The adverse event rate was 2.6%, and no patient discontinued treatment due to adverse events related to GLE/PIB. CONCLUSION: Consistent with other real-world studies and clinical trials, treatment with GLE/PIB showed high effectiveness and tolerability overall and in difficult-to-treat subgroups (ClinicalTrials.gov: NCT03303599).