Gastroenterology Clinical Trials Transparency: An Analysis of Publication Rates From the ClinicalTrials.gov Database.

INTRODUCTION: There is limited information on the transparency of gastroenterology clinical trials. METHODS: The ClinicalTrials.gov database was searched for trials focused on most common gastrointestinal diseases up to August 2018. Adherence to reporting of results to the database or in publication form was recorded for each trial along with trial characteristics. RESULTS: Of the 2,429 trials included in the final analysis, 1824 (75%, 95% confidence interval: 73.4%-76.8%) had results on ClinicalTrials.gov or in the form of a publication. However, only 534 (29%) had results posted on ClinicalTrials.gov. DISCUSSION: Improvement of clinical trial transparency is needed in gastroenterology.

Reducing Overuse of Proton Pump Inhibitors for Stress Ulcer Prophylaxis and Nonvariceal Gastrointestinal Bleeding in the Hospital: A Narrative Review and Implementation Guide.

Proton pump inhibitors (PPIs) are among the most commonly used medications in the world; however, these drugs carry the risk of patient harm, including acute and chronic kidney disease, Clostridium difficile infection, hypomagnesemia, and fractures. In the hospital setting, PPIs are overused for stress ulcer prophylaxis and gastrointestinal bleeding, and PPI use often continues after discharge. Numerous multifaceted interventions have demonstrated safe and effective reduction of PPI use in the inpatient setting. This narrative review and the resulting implementation guide summarize published interventions to reduce inappropriate PPI use and provide a strategy for quality improvement teams.

TeleInGEstion Remote Video Capsule Endoscope.

We describe 2 cases in which video capsule endoscopy was performed remotely using TeleInGEstion Remote Video Capsule Endoscopy (TIGER VCE), given limited access to endoscopy during the COVID-19 pandemic. The patients ingested the CapsoCam capsule during a televisit, and the video was subsequently reviewed remotely by the physician. TIGER VCE was used to diagnose a benign etiology of melena and used to confirm a diagnosis of Crohn's disease before the initiation of biologic therapy. These cases demonstrate the safety and efficacy of TIGER VCE. We feel that this technique may be considered as a standard ingestion technique in the future.

Polyp Detection Rate Correlates Strongly with Adenoma Detection Rate in Trainee Endoscopists.

BACKGROUND: The adenoma detection rate (ADR) is a widely accepted quality benchmark for screening colonoscopy but can be burdensome to calculate. Previous studies have shown good correlation between polyp detection rate (PDR) and ADR, but this has not been validated in trainees. Additionally, the correlation between PDR and detection rates for sessile serrated polyps (SSPDR) and advanced neoplasia (ANDR) is not well studied. AIMS: We investigated the relationship between PDR and ADR, SSPDR, and ANDR in trainees. METHODS: We examined 1600 outpatient colonoscopies performed by 24 trainees at a VA hospital from 2014 to 2017. Variables collected included patient demographics, year of fellowship, colonoscopy indication, and endoscopic and histologic findings. We calculated the overall ratios of PDR to ADR, SSPDR, and ANDR to assess the correlation between measured and calculated ADR, SSPDR, and ANDR, which is equivalent to the correlation between PDR and measured ADR, SSPDR, and ANDR. RESULTS: The overall PDR, ADR, SSPDR, and ANDR were 72%, 52%, 2%, and 14%. PDR (48%) was highest in the left colon, while ADR (32%) and ANDR (7%) were highest in the right colon (p < 0.001 for all). The overall ADR/PDR, SSPDR/PDR, and ANDR/PDR ratios were 0.73, 0.03, and 0.20. Correlation between PDR and ADR was highly positive overall (r = 0.87, p < 0.0001) and stronger in the right (r = 0.91) and transverse (r = 0.94) colon than the left colon (r = 0.80). Correlation between PDR and overall SSPDR and ANDR were not statistically significant. CONCLUSIONS: PDR can serve as a surrogate measure of ADR to monitor colonoscopy quality in gastroenterology fellowship.

Reliability and Clinical Correlation of Transcranial Doppler Ultrasound in Sturge-Weber Syndrome.

BACKGROUND: The reproducibility of transcranial Doppler (TCD) ultrasound measurements in Sturge-Weber syndrome (SWS) and TCD's ability to predict neurological progression is unknown. METHODS: In 14 individuals with SWS, TCD measured mean flow velocity, pulsatility index, peak systolic velocity, and end-diastolic velocity in the middle, posterior, and anterior cerebral arteries of the affected and unaffected hemisphere. TCD was performed either once (n = 5) or twice in one day (n = 9). We assessed the reproducibility of the measurements performed twice on the same day on subjects and compared the TCD measurements to previously published age-matched controls. Clinically obtained neuroimaging was scored for extent and severity of SWS brain involvement. Patients were prospectively assigned SWS neuroscores. RESULTS: Middle cerebral artery velocity (r = 0.79, P = 0.04, n = 7), posterior cerebral artery velocity (r = 0.90, P = 0.04, n = 5), and anterior cerebral artery pulsatility index (r = 0.82, P = 0.02, n = 7) were reproducible TCD measurements comparing same-day percent side-to-side differences. In subjects with SWS, affected and unaffected mean peak systolic velocity and end-diastolic velocity in the middle, posterior, and anterior cerebral arteries were globally lower compared with age-matched control subjects. Subjects with the lowest affected middle cerebral artery velocity had the greatest worsening in the total neurological score between time 1 and 2 (r = -0.73, P = 0.04, n = 8) and the most severe magnetic resonance imaging involvement of the affected frontal lobe (r = -0.82, P = 0.007, n = 9). CONCLUSIONS: TCD may be a reliable measure with potential clinical value, indicating that blood flow may be globally decreased in SWS patients with unilateral brain involvement.

[Formula: see text]Intellectual and adaptive functioning in Sturge-Weber Syndrome.

The present study examined the intellectual and adaptive functioning in a sample of children and young adults with Sturge-Weber Syndrome (SWS). A total of 80 research participants from a SWS study database underwent full neurological evaluation as part of their participation or concurrent medical care. Twenty-nine of the participants received neuropsychological evaluations. Analyses indicated no significant demographic or neurological differences between those who did and did not receive neuropsychological evaluations. Overall, the neuropsychological evaluation sample displayed significantly lower functioning relative to published normative data across domains of intellectual and adaptive functioning. Thirty-two percent of the sample displayed impaired performance (standard score ≤ 75) in intellectual functioning and 58% displayed impaired performance in adaptive functioning. Hemiparesis status independently predicted overall adaptive functioning while seizure frequency independently predicted overall intellectual functioning. Younger participants displayed significantly higher (more intact) ratings in adaptive functioning compared to older participants, specifically in overall adaptive functioning, motor skills, and community living skills. A composite measure of neurological status (SWS-NRS) incorporating seizure and hemiparesis status effectively distinguished between individuals with impaired or nonimpaired adaptive and intellectual functioning and showed promise as a screening method for identifying individuals with more involved intellectual and/or adaptive needs.

Urine vascular biomarkers in Sturge-Weber syndrome.

Sturge-Weber syndrome (SWS) consists of a capillary-venous vascular malformation of the brain, skin and eye. Urine vascular biomarkers have been demonstrated to be abnormal in other vascular anomalies and to correlate with clinical severity and progression. The current study investigated the use of urinary matrix metalloproteinase (MMP)-2, MMP-9, vascular endothelial growth factor (VEGF), and basic fibroblast growth factor (bFGF) levels to non-invasively monitor the progression of SWS. Fifty-four urine samples were collected from patients seen at the Hunter Nelson Sturge-Weber Center at Kennedy Krieger Institute. Urine was analyzed for MMP-2, MMP-9, VEGF and bFGF levels and correlated with clinical outcome at the time of urine collection (n = 48) and 1 year following urine collection (n = 22). Analysis revealed that MMP-2 (p = 0.033) and MMP-9 (p = 0.010) were significantly more likely to be present in the urine of SWS subjects compared to controls and that bFGF was significantly more likely to be present at abnormal levels (p = 0.005). MMP-2 correlated with a more severe clinical score at the time of urine collection, while both MMP-2 and MMP-9 levels correlated with greater disease severity at time of collection. bFGF levels correlated with improved clinical score 1 year after urine collection. These results suggest that MMP-2 and MMP-9 levels may be useful in assessing SWS progression, as well as indicating which patients might benefit from more aggressive treatment, while bFGF levels may be useful in judging the efficacy of neurologic treatment in SWS.

Importance of utilizing a sensitive free thyroxine assay in Sturge-Weber syndrome.

Sturge-Weber syndrome has been found to result in hypothalamic-pituitary dysfunction including central hypothyroidism. Because central hypothyroidism is more prevalent in Sturge-Weber syndrome than in the general population, we routinely evaluated thyroid function. Here we describe 5 children with Sturge-Weber syndrome on anticonvulsants and diagnosed with hypothyroidism based on thyroid function testing. All 5 patients were eventually tested utilizing the more accurate free thyroxine equilibrium dialysis assay. Results indicated that only 2 of the 5 patients, who exhibited the most severe symptoms, had true hypothyroidism. This case series demonstrates the benefits of using the free thyroxine by equilibrium dialysis when testing Sturge-Weber syndrome patients on antiepileptic medications. This testing algorithm is more cost-effective and also improves the quality of care by providing an accurate diagnosis more quickly. In addition, we propose consideration of this testing method in any patient taking anticonvulsants, most notably oxcarbazepine.

Aspirin use in Sturge-Weber syndrome: side effects and clinical outcomes.

Sturge-Weber syndrome is a neurocutaneous disorder with skin, eye, and brain involvement. Prior series suggest about 50% of patients have seizures/neurodeterioration. Low-dose (3-5 mg/kg/d) aspirin use in this population is controversial. This study further addresses the side effects and outcomes of low-dose aspirin usage in Sturge-Weber syndrome. Fifty-eight subjects on aspirin with brain involvement were analyzed in a retrospective chart review. Charts were evaluated for brain involvement, age at first seizure, and side effects. Subjects' clinical stability was compared using neurologic scores. The majority of subjects had neurologic scores reflecting reasonable seizure control (91%), none or mild hemiparesis (57%), no vision impairment (71%), and none or mild cognitive impairment (80%). Forty-nine reported no significant side effects, and 9 reported either allergic reaction or minimal to significant bleeding on aspirin. This cohort's clinical experience adds significant support for low-dose aspirin use to optimize neurodevelopmental outcome in Sturge-Weber syndrome with minimal side effects.