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

Nuevas aplicaciones de la cápsula endoscópica: PILLCAM™ ESO

ABSTRACT Capsule endoscopy has opened a new era in small bowel examination. Its indications are now welldefined and currently, wireless capsule endoscopy is considered as the first-line imaging tool for the diagnosis of small bowel diseases. ECE has been shown to be feasible, safe and a good alternative technique in patients refusing conventional endoscopy. Although results reported in both GERD and cirrhotic patients are encouraging, great differences in terms of accuracy (particularly in GERD patients) have been found in published studies. These differences have been attributed to study designs, the lack of adequate experience and inconvenience of ingestion protocols. In summary, more large-scale studies evaluating the new 14-fps capsule, adequate ECE-experience and new modified ingestion protocols are still needed

Pharmacokinetics of epinephrine in patients with septic shock: modelization and interaction with endogenous neurohormonal status

Introduction In septic patients, an unpredictable response to epinephrine may be due to pharmacodynamic factors or to non-linear pharmacokinetics. The purpose of this study was to investigate the pharmacokinetics of epinephrine and its determinants in patients with septic shock. Methods Thirty-eight consecutive adult patients with septic shock were prospectively recruited immediately before epinephrine infusion. A baseline blood sample (C0) was taken to assess endogenous epinephrine, norepinephrine, renin, aldosterone, and plasma cortisol levels before epinephrine infusion. At a fixed cumulative epinephrine dose adjusted to body weight and under steady-state infusion, a second blood sample (C1) was taken to assess epinephrine and norepinephrine concentrations. Data were analyzed using the nonlinear mixed effect modeling software program NONMEM. Results Plasma epinephrine concentrations ranged from 4.4 to 540 nmol/L at steady-state infusion (range 0.1 to 7 mg/hr; 0.026 to 1.67 μg/kg/min). A one-compartment model adequately described the data. Only body weight (BW) and New Simplified Acute Physiologic Score (SAPSII) at intensive care unit admission significantly influenced epinephrine clearance: CL (L/hr) = 127 × (BW/70)0.60 × (SAPS II/50)-0.67. The corresponding half-life was 3.5 minutes. Endogenous norepinephrine plasma concentration significantly decreased during epinephrine infusion (median (range) 8.8 (1 – 56.7) at C0 vs. 4.5 (0.3 – 38.9) nmol/L at C1, P < 0.001). Conclusions Epinephrine pharmacokinetics is linear in septic shock patients, without any saturation at high doses. Basal neurohormonal status does not influence epinephrine pharmacokinetics. Exogenous epinephrine may alter the endogenous norepinephrine metabolism in septic patients

A DNA-Modified Live Vaccine Prime-Boost Strategy Broadens the T-Cell Response and Enhances the Antibody Response against the Porcine Reproductive and Respiratory Syndrome Virus.

The Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) induces reproductive disorders in sows and respiratory illnesses in growing pigs and is considered as one of the main pathogenic agents responsible for economic losses in the porcine industry worldwide. Modified live PRRSV vaccines (MLVs) are very effective vaccine types against homologous strains but they present only partial protection against heterologous viral variants. With the goal to induce broad and cross-protective immunity, we generated DNA vaccines encoding B and T antigens derived from a European subtype 1 strain that include T-cell epitope sequences known to be conserved across strains. These antigens were expressed either in a native form or in the form of vaccibodies targeted to the endocytic receptor XCR1 and CD11c expressed by different types of antigen-presenting cells (APCs). When delivered in skin with cationic nanoparticles and surface electroporation, multiple DNA vaccinations as a stand-alone regimen induced substantial antibody and T-cell responses, which were not promoted by targeting antigens to APCs. Interestingly, a DNA-MLV prime-boost strategy strongly enhanced the antibody response and broadened the T-cell responses over the one induced by MLV or DNA-only. The anti-nucleoprotein antibody response induced by the DNA-MLV prime-boost was clearly promoted by targeting the antigen to CD11c and XCR1, indicating a benefit of APC-targeting on the B-cell response. In conclusion, a DNA-MLV prime-boost strategy, by enhancing the potency and breadth of MLV vaccines, stands as a promising vaccine strategy to improve the control of PRRSV in infected herds

Capsule endoscopy interpretation: the role of physician extenders

Background and aims: capsule endoscopy (CE) allows for a new era in small-bowel examination. Nevertheless, physicians’ time for CE-interpretation remains longer than desirable. Alternative strategies to physicians have not been widely investigated. The aim of this study was to evaluate the accuracy of physician extenders in CE-interpretation. Material and methods: one CE-experienced gastroenterologist and two physician extenders reviewed independently 20 CEprocedures. Each reader was blinded to the findings of their colleagues. A consensus formed by the readers and a second CE-experienced gastroenterologist was used as gold standard. Number, type and location of images selected, character of CEexams and their relationship with indications were recorded. Gastric emptying time (GEt), small-bowel transit time (SBTt) and time spent by readers were also noted. Results: sensitivity and specificity for “overall” lesions was 79 and 99% for the gastroenterologist; 86 and 43% for the nurse; and 80 and 57% for the resident. All 34 “major” lesions considered by consensus were found by the readers. Agreement between consensus and readers for images classification and procedures interpretation was good to excellent (κ from 0.55 to 1). No significant differences were found in the GEt and SBTt obtained by consensus and readers. The gastroenterologist was faster than physician extenders (mean time spent was 51.9 ± 13.5 minutes versus 62.2 ± 19 and 60.9 ± 17.1 for nurse and resident, respectively; p < 0.05). Conclusions: physician extenders could be the perfect complement to gastroenterologists for CE-interpretation but gastroenterologists should supervise their findings. Future cost-efficacy analyses are required to assess the benefits of this alternative

Panenteric capsule endoscopy identifies proximal small bowel disease guiding upstaging and treatment intensification in Crohn&#8217;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

International core curriculum for capsule endoscopy training courses

Capsule endoscopy (CE) has become a first-line noninvasive tool for visualisation of the small bowel (SB) and is being increasingly used for investigation of the colon. The European Society of Gastrointestinal Endoscopy (ESGE) guidelines have specified requirements for the clinical applications of CE. However, there are no standardized recommendations yet for CE training courses in Europe. The following suggestions in this curriculum are based on the experience of European CE training courses directors. It is suggested that 12 hours be dedicated for either a small bowel capsule endoscopy (SBCE) or a colon capsule endoscopy (CCE) course with 4 hours for an introductory CCE course delivered in conjunction with SBCE courses. SBCE courses should include state-of-the-art lectures on indications, contraindications, complications, patient management and hardware and software use. Procedural issues require approximately 2 hours. For CCE courses 2.5 hours for theoretical lessons and 3.5 hours for procedural issued are considered appropriate. Hands-on training on reading and interpretation of CE cases using a personal computer (PC) for 1 or 2 delegates is recommended for both SBCE and CCE courses. A total of 6 hours hands-on session- time should be allocated. Cases in a SBCE course should cover SB bleeding, inflammatory bowel diseases (IBD), tumors and variants of normal and cases with various types of polyps covered in CCE courses. Standardization of the description of findings and generation of high-quality reports should be essential parts of the training. Courses should be followed by an assessment of trainees' skills in order to certify readers' competency.info:eu-repo/semantics/publishedVersio

Gastroduodenal injury after radioembolization of hepatic tumors

Radioembolization is a new tool for the treatment of hepatic tumors that consists in the injection of biocompatible microspheres carrying radioisotopes into the hepatic artery or its branches. METHODS: We have performed radioembolization in 78 patients with hepatic tumors using resin-based microspheres loaded with yttrium-90. All patients were previously evaluated to minimize the risk of hazardous irradiation to nontarget organs and to obtain the data needed for dose calculation. RESULTS: We report a complication found in three cases (3.8%) that consists of abdominal pain resulting from gastroduodenal lesions and that had a chronic, insidious course. Microscopically, microspheres were detected in the specimens obtained from all affected gastric areas. Since these gastroduodenal lesions do not appear when nonradiating microspheres are injected in animals, lesions are likely to be due to radiation and not to an ischemic effect of vascular occlusion by spheres. CONCLUSIONS: We believe that a pretreatment evaluation that includes a more thorough scrutiny of the hepatic vascularization in search of small collaterals connecting to the gastroduodenal tract can help prevent this awkward complicatio

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)