Multicenter, randomized study to optimize bowel for colon capsule endoscopy

AIM To assess the cleansing efficacy and safety of a new Colon capsule endoscopy (CCE) bowel preparation regimen. METHODS This was a multicenter, prospective, randomized, controlled study comparing two CCE regimens. Subjects were asymptomatic and average risk for colorectal cancer. The second generation CCE system (PillCam® COLON 2; Medtronic, Yoqneam, Israel) was utilized. Preparation regimens differed in the 1st and 2nd boosts with the Study regimen using oral sulfate solution (89 mL) with diatrizoate meglumine and diatrizoate sodium solution (“diatrizoate solution”) (boost 1 = 60 mL, boost 2 = 30 mL) and the Control regimen oral sulfate solution (89 mL) alone. The primary outcome was overall and segmental colon cleansing. Secondary outcomes included safety, polyp detection, colonic transit, CCE completion and capsule excretion = 12 h. RESULTS Both regimens had similar cleansing efficacy for the whole colon (Adequate: Study = 75.9%, Control = 77.3%; P = 0.88) and individual segments. In the Study group, CCE completion was superior (Study = 90.9%, Control = 76.9%; P = 0.048) and colonic transit was more often \u3c 40 min (Study = 21.8%, Control = 4%; P = 0.0073). More Study regimen subjects experienced adverse events (Study = 19.4%, Control = 3.4%; P = 0.0061), and this difference did not appear related to diatrizoate solution. Adverse events were primarily gastrointestinal in nature and no serious adverse events related either to the bowel preparation regimen or the capsule were observed. There was a trend toward higher polyp detection with the Study regimen, but this did not achieve statistical significance for any size category. Mean transit time through the entire gastrointestinal tract, from ingestion to excretion, was shorter with the Study regimen while mean colonic transit times were similar for both study groups. CONCLUSION A CCE bowel preparation regimen using oral sulfate solution and diatrizoate solution as a boost agent is effective, safe, and achieved superior CCE completion. © The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved

Panenteric capsule endoscopy identifies proximal small bowel disease guiding upstaging and treatment intensification in Crohn’s disease: A European multicentre observational cohort study

Background: Endoscopically defined mucosal healing in Crohn\u2019s disease is associated with improved outcomes. Panenteric capsule endoscopy enables a single non-invasive assessment of small and large bowel mucosal inflammation. Aims and methods: This multicentre observational study of patients with suspected and established Crohn\u2019s disease examined the feasibility, safety and impact on patient outcomes of panenteric capsule endoscopy in routine clinical practice. The potential role in assessment of disease severity and extent by a comparison with existing clinical and biochemical markers is examined. Results: Panenteric capsule endoscopy was performed on 93 patients (71 with established and 22 with suspected Crohn\u2019s disease). A complete examination occurred in 85% (79/93). Two cases (2.8%) of capsule retention occurred in patients with established Crohn\u2019s disease. Panenteric capsule resulted in management change in 38.7% (36/93) patients, including 64.6% (32/48) of those with an established diagnosis whose disease was active, and all three patients with newly diagnosed Crohn\u2019s disease. Montreal classification was upstaged in 33.8% of patients with established Crohn\u2019s disease and mucosal healing was demonstrated in 15.5%. Proximal small bowel disease upstaged disease in 12.7% and predicted escalation of therapy (odds ratio 40.3, 95% confidence interval 3.6\u2013450.2). Raised C-reactive protein and faecal calprotectin were poorly sensitive in detecting active disease (0.48 and 0.59 respectively). Conclusions: Panenteric capsule endoscopy was feasible in routine practice and the ability to detect proximal small bowel disease may allow better estimation of prognosis and guide treatment intensification. Panenteric capsule endoscopy may be a suitable non-invasive endoscopic investigation in determining disease activity and supporting management decisions

Pharmacokinetics of intramuscular tranexamic acid in bleeding trauma patients: a clinical trial.

BACKGROUND: Intravenous tranexamic acid (TXA) reduces bleeding deaths after injury and childbirth. It is most effective when given early. In many countries, pre-hospital care is provided by people who cannot give i.v. injections. We examined the pharmacokinetics of intramuscular TXA in bleeding trauma patients. METHODS: We conducted an open-label pharmacokinetic study in two UK hospitals. Thirty bleeding trauma patients received a loading dose of TXA 1 g i.v., as per guidelines. The second TXA dose was given as two 5 ml (0·5 g each) i.m. injections. We collected blood at intervals and monitored injection sites. We measured TXA concentrations using liquid chromatography coupled to mass spectrometry. We assessed the concentration time course using non-linear mixed-effect models with age, sex, ethnicity, body weight, type of injury, signs of shock, and glomerular filtration rate as possible covariates. RESULTS: Intramuscular TXA was well tolerated with only mild injection site reactions. A two-compartment open model with first-order absorption and elimination best described the data. For a 70-kg patient, aged 44 yr without signs of shock, the population estimates were 1.94 h-1 for i.m. absorption constant, 0.77 for i.m. bioavailability, 7.1 L h-1 for elimination clearance, 11.7 L h-1 for inter-compartmental clearance, 16.1 L volume of central compartment, and 9.4 L volume of the peripheral compartment. The time to reach therapeutic concentrations (5 or 10 mg L-1) after a single intramuscular TXA 1 g injection are 4 or 11 min, with the time above these concentrations being 10 or 5.6 h, respectively. CONCLUSIONS: In bleeding trauma patients, intramuscular TXA is well tolerated and rapidly absorbed. CLINICAL TRIAL REGISTRATION: 2019-000898-23 (EudraCT); NCT03875937 (ClinicalTrials.gov)

El Servicio de Validación de Copernicus EMS como vector de mejora de la cartografía de emergencias basada en Sentinel

[EN] The Copernicus Emergency Management Service (CEMS) is coordinated by the European Commission and “provides all actors involved in the management of natural disasters, man-made emergency situations, and humanitarian crises with timely and accurate geo-spatial information derived from satellite remote sensing and complemented by available in situ or open data sources”. It includes two components, Early Warning and Monitoring and Mapping. The latter provides on demand geo-spatial information derived from satellite imagery during all phases of the disaster management cycle. It includes 3 systems, Rapid Mapping (RM), Risk and Recovery Mapping (RRM), and a Validation Service. RM provides geospatial information immediately after a disaster to assess its impact; RRM in the prevention, preparation and reconstruction phases; and the Validation Service is in charge of validating and verifying the products generated by both, and of collecting and analyzing users’ feedback. The wide spectrum of activities framed in the Validation Service has allowed it to become a vector to improve the Mapping component through the testing of new methodologies, data input type, or approach for the creation of emergency cartography in the frame of the CEMS. The present paper introduces the main investigation lines based on Sentinel-1 and 2 for flood and fire monitoring that could be implemented in the CEMS services taking into consideration the characteristics of the Mapping component in terms of products to create and time constraints. The applicability of Sentinel-1 for flood monitoring based on the backscattering, the MultiTemporal Coherence (MTC), and dual polarization; and for burnt area delineation based on MTC was studied, while Sentinel-2 was used for burnt area delineation based on vegetation indices. Results indicate that proposed methodologies might be appropriate for the creation of crisis information products in large areas, due to the relative easy and fast implementation compared to classic photo interpretation, although further applicability analyses should be carried out.[ES] El Servicio de Gestión de Emergencias de Copernicus (CEMS), está coordinado por la Comisión Europea y “provee de información geoespacial precisa y oportuna derivada de la teledetección satelital y completada por fuentes de datos disponibles in situ o abiertas a todos los actores involucrados en la gestión de emergencias, bien sean derivadas de desastres naturales o producidos por el hombre, o de crisis humanitarias”. El servicio tiene dos componentes, uno de alerta temprana y monitoreo y otro de creación de mapas. El servicio de mapeo se encarga de proveer, bajo demanda, a los diferentes agentes de emergencias de información geoespacial derivada de imágenes de satélite en todas las fases de la gestión de emergencias, consta de 3 sistemas, Rapid Mapping (RM), Risk and Recovery Mapping (RRM), y Validation. RM aporta información inmediatamente después de un desastre para evaluar su impacto; RRM en las fases de prevención, preparación y reconstrucción; y la Validación se encarga de validar y verificar los productos generados por ambos, y de recoger y analizar los comentarios de los usuarios. El amplio espectro de actividades enmarcadas en él le ha permitido ser vector de mejora de los servicios de mapeo de emergencias mediante el testeo de nuevas metodologías, tipos de datos, o enfoques para la creación de cartografías de emergencias en el marco de CEMS. El presente artículo describe las principales líneas de investigación en el uso de datos Sentinel-1 y 2 para la monitorización de inundaciones e incendios, que se podrían implementar en el futuro en el marco de CEMS. La aplicabilidad de Sentinel-1 para el monitoreo de inundaciones basado en la retrodispersión, la coherencia multitemporal (MTC) y la polarización dual; y se estudió la delimitación del área quemada basada en MTC. Sentinel-2 se usó para delimitar áreas quemadas en base a índices de vegetación. Los resultados indican que las metodologías propuestas podrían ser apropiadas para la creación de productos de información de crisis en grandes áreas, debido a la implementación relativamente fácil y rápida en comparación con la fotointerpretación clásica, aunque deberían realizarse más análisis para su aplicación en el marco de CEMS.The authors gratefully acknowledge the contribution of Massimiliano Rossi and Antigoni Maistrali for the preparation of the materials analysed in this work.Donezar-Hoyos, U.; Albizua-Huarte, L.; Amezketa-Lizarraga, E.; Barinagarrementeria-Arrese, I.; Ciriza, R.; De Blas-Corral, T.; Larrañaga-Urien, A.... (2020). The Copernicus EMS Validation service as a vector for improving the emergency mapping based on Sentinel data. Revista de Teledetección. 0(56):23-34. https://doi.org/10.4995/raet.2020.13770OJS233405

Nomenclature and semantic description of vascular lesions in small bowel capsule endoscopy: an international Delphi consensus statement

Background and study aims \u2002Nomenclature and descriptions of small bowel (SB) vascular lesions in capsule endoscopy (CE) are scarce in the medical literature. They are mostly based on the reader's opinion and thus differ between experts, with a potential negative impact on clinical care, teaching and research regarding SBCE. Our aim was to better define a nomenclature and to give a description of the most frequent vascular lesions in SBCE. Methods \u2002A panel of 18 European expert SBCE readers was formed during the UEGW 2016 meeting. Three experts constructed an Internet-based four-round Delphi consensus, but did not participate in the voting process. They built questionnaires that included various still frames of vascular lesions obtained with a third-generation SBCE system. The 15 remaining participants were asked to rate different proposals and description of the most common SB vascular lesions. A 6-point rating scale (varying from 'strongly disagree' to 'strongly agree') was used successive rounds. The consensus was reached when at least 80\u200a% voting members scored the statement within the 'agree' or 'strongly agree'. Results \u2002Consensual terms and descriptions were reached for angiectasia/angiodysplasia, erythematous patch, red spot/dot, and phlebectasia. A consensual description was reached for more subtle vascular lesions tentatively named "diminutive angiectasia" but no consensus was reached for this term. Conclusion \u2002An international group has reached a consensus on the nomenclature and descriptions of the most frequent and relevant SB vascular lesions in CE. These terms and descriptions are useful in daily practice, for teaching and for medical research purposes

Clinical pharmacodynamic factors in docetaxel toxicity

Neutropenia is the main dose-limiting toxicity occurring in docetaxel treatment. The objective of this study was to identify pharmacodynamic (PD) factors responsible for the neutropaenia caused by docetaxel. Data were obtained from 92 patients treated with docetaxel as a monochemotherapy in two different treatment centres. A semiphysiological population pharmacokinetic–pharmacodynamic (PK/PD) model was applied to describe the time course of neutrophils and the neutropaenic effect of docetaxel. The plasma docetaxel concentration was assumed to inhibit the proliferation of neutrophil precursors through a linear model: Drug effect=Slope × Conc. Slope corresponds to the patients' sensitivity to the neutropaenic effect of docetaxel. Covariate analysis was performed by testing the relationship between the patients' characteristics and Slope using the program NONMEM. The neutropaenic effect of docetaxel showed a high interindividual variability. Three significant PD covariates were identified: serum α1-acid glycoprotein levels (AAG), level of chemotherapy pretreatment, and treatment centre. Extensive pretreatment was associated with an increase in Slope values meaning a higher haematotoxicity. An increase in AAG was associated with a decrease of both Slope and docetaxel plasma clearance. Patients treated in one centre had both higher Slope and docetaxel clearance. The centre effect (most likely due to a bias in the PK part of the study between the two centres) reveals the robustness of the PK/PD model. Individual dosing of docetaxel should be based on previous chemotherapy but not on the AAG level since it has a similar influence on PD and PK docetaxel parameters. This methodology should be applied to further investigate elderly patients and to identify more precisely the characteristics of previous chemotherapy that contribute to the cumulative myelotoxicity

La secuencia magmática Jurásico Superior-Cretácico Superior en la Cordillera Central, República Dominicana: sección cortical de un arco-isla intraoceánico.

The Late Jurassic-Late Cretaceous magmatic sequence exposed in the central-western sector of the Cordillera Central Dominican Republic, can be divided in five main lithostratigraphic units formed by plutonio, volcanic, volcanoclastic and sedimentary rocks. All rocks have suffered very heterogeneous ductile deformation and low-grade metamorphism with magmatic textures often preserved. From bottom to top, this magmatic sequence is made up of:: (1) Loma Caribe serpentinized peridotites, (2) the N-MORB volcano-plutonic assemblage of El Aguacate, of ophiolitic affinity, (3) the Duarte Complex oceanic plateau, (4) the arc-related volcanic and volcano-sedimentary sequence of the Tireo Formation, intruded by the Loma de Cabrera Batolith, and (5) the massive basaltic flows of Peña Blanca y Nalga de Maco. It is suggested that the magmatic sequence represents the crustal section of an intra-oceanic island arc, which was built onto a proto-caribbean oceanic crust and an overlying Lower Cretaceous oceanic plateau. The sequence is overlain by Upper Cretaceous basalts of the Caribbean oceanic plateau and limestones