bluuebunny/crossref_metadata_2025 huggingface dataset:
395 Determining the Necessity for Separate Histologic Evaluations of Proximal and Distal Biopsies in Adult Eosinophilic Esophagitis
Authors: Yazdian Aaron , Choksi Yash , Willey Jade , Patel Dhyanesh , Slaughter Christopher , Higginbotham Tina , Vaezi Michael
Published: October 2019

INTRODUCTION:

Proton Pump Inhibitors (PPIs) can induce remission in up to 1/2 of patients with EoE. Understanding clinical or pathologic features of EoE that are associated with PPI-responsiveness could inform choice of PPI for therapy, rather than diet or topical steroids. The aim of this study was to determine if evaluation of mid esophageal biopsies separately from distal esophageal biopsies could reveal information important in predicting PPI response.

METHODS:

We utilized a de-identified database containing information derived from our institution’s electronic medical record between 2000-2017. We queried this database for patients with an ICD9 or ICD10 code for Eosinophilic Esophagitis. A total of 1,198 patients resulted. These records were manually reviewed, and an EoE diagnosis was confirmed in 749/1198 by a pathology report showing an esophageal biopsy containing an eosinophil count with ≥ 15 eosinophils/high power field. Patients with ≥ 15 eosinophils/high power field in both mid and distal esophageal biopsies (separately reported) with ≤ 15 eosinophils/high power field in both mid and distal biopsies following PPI therapy were considered to be PPI-responsive, while those with ≥ 15 eosinophils/high power field in either biopsy after PPI therapy were considered to be not responsive to PPI. 564/749 patients were excluded due to interventions other than PPI or lack of pre-EGD or post-EGD data.

RESULTS:

Our study constituted 43 PPI-responsive and 142 non-responsive patients (median age 23 vs.18 years, respectively; male 67% vs 68%, respectively). Dysphagia was the most common indication for EGD (56%, refer to Table 1). Patients non-responsive to PPI demonstrated a trend towards a longer duration of symptoms prior to EoE diagnosis (24 vs. 12 months, P = 0.14). In PPI-responsive patients, pre-EGD eosinophils/high power field were significantly lower in number in the mid (21 vs. 44, Figure 1, P < 0.001) and distal (30 vs. 50, P < 0.001) esophageal biopsies.

CONCLUSION:

Biopsies in the mid and distal esophagus had significantly fewer eosinophils in EoE patients that respond to PPI versus those that do not. Perhaps this information can be used in conjunction with other data to predict PPI response. In the future, we plan to validate these findings in other populations and examine the differences of other EoE histologic features in mid and distal esophageal biopsies.
401 EGJ Outflow Obstruction in Setting of Opiate Use Is Associated With Esophageal Spasticity and Hypercontractility
Authors: Jonas Daniel , Foromera Joshua , Ross Kristina , Menard-Katcher Paul , Kaizer Alexander , Yadlapati Rena
Published: October 2019

INTRODUCTION:

Esophagogastric junction outflow obstruction (EGJOO) is an increasingly diagnosed motility disorder defined by an elevated integrated relaxation pressure without meeting criteria for achalasia subtypes per the Chicago Classification v3.0. Various mechanisms may contribute to an EGJOO motility pattern such as effect from opiates, hiatal hernia, or normal physiology. We hypothesize that esophageal motility patterns differ across mechanisms of EGJOO. The aim of this study was to compare physiologic factors across sub-groups of patients with EGJOO.

METHODS:

This was a retrospective study of adult patients who underwent high-resolution manometry at a single academic center over 59 months (1/2014-11/2018). Demographics, medical/surgical history, medications, and manometry results were collected from the electronic health record. Patients diagnosed with EGJOO and without prior foregut surgery were included in the analysis. Patients were further classified according to whether they had a hiatal hernia and/or opiate use. Fisher’s exact test and a Wald test from linear regression was used to compare EGJOO sub-groups for categorical and continuous variables, respectively.

RESULTS:

Of 912 patients who underwent manometry over 59 months, 114 (13%) had EGJOO; 26 were excluded due to history of foregut disease. Therefore, 88 patients with EGJOO are included in this analysis: 29 (33%) male, mean age 59.1 years (SD 13.6), mean body mass index 26.4 kg/m2 (SD 5.7) [Table 1]. The 88 patients were sub-grouped as: EGJOO + Hernia 25 (28%), EGJOO + Opiate 18 (21%), and EGJOO without hernia or opiate use 45 (51%). Patients with EGJOO + Opiate had a significantly higher distal contractile integral than EGJOO + Hernia (4132 (SD 2079) vs 2147 (SD 2166) mmHg-s-cm; P = 0.03) and a greater proportion of hypercontractile swallows than those with EGJOO + Hernia or EGJOO without hernia or opiate use (P = 0.06). Additionally, EGJOO + Opiate use had a shorter mean distal latency than those with EGJOO + Hernia or EGJOO without hernia or opiate use (P = 0.17) [Table 2].

CONCLUSION:

In this study of 88 patients with EGJOO, patients with EGJOO and opiate use exhibited increased esophageal contractility and spasticity compared to those without opiate use. These results support the notion that mechanisms of EGJOO vary, and that spasticity may explain EGJOO in patients using opiates. Further research should assess the efficacy of treatments targeting esophageal spasticity in patients with EGJOO that are unable to stop opiates.
417 Lack of Peristaltic Reserve as Detected by Multiple Rapid Swallows on HRM Predicts Development of Dysphagia Following Magnetic Sphincter Augmentation for GERD
Authors: Dominguez-Profeta Rebeca , Horgan Santiago , Cheverie Joslin , Cubas Robert , Kunkel David C.
Published: October 2019

INTRODUCTION:

Magnetic Sphincter Augmentation (MSA) is an antireflux procedure that can be performed on patients with normal esophageal motor function. The most common side-effect of MSA is dysphagia, which occurs in 34-38% of patients and may require dilation (Lipham JC et al, 2015). Multiple rapid swallows (MRS) is a provocative maneuver during high resolution esophageal manometry (HRM) that assesses peristaltic reserve; impaired MRS has previously been shown to predict the development of dysphagia following fundoplication (Shaker A et al, 2013). We hypothesized that impaired MRS may predict which patients experience dysphagia following laparoscopic MSA.

METHODS:

Retrospective review of all patients who underwent MSA at a tertiary academic center from May 2015 to May 2018. All patients completed a standardized esophageal questionnaire and pre-operative HRM which included MRS. Peristaltic augmentation with MRS was defined as a ratio >1 of the distal contractile integral (DCI) following MRS and the median DCI of the 10 baseline wet swallows. Demographics, MSA implant size, and symptom data from post-operative follow-up of at least 6 months was gathered on all patients.

RESULTS:

29 patients (age 52 ± 17 years, 59% female, BMI 25 ± 4.2 kg/m2) were identified. Postoperatively, 15 patients developed dysphagia, 9 of them within the first 2 weeks. 5 patients required balloon dilatation for symptom relief. Among the patients that did not develop dysphagia, peristaltic augmentation with MRS was present in 42.9% compared to 6.7% of patients who developed dysphagia (P-value 0.03). 40% of the patients that required balloon dilatation exhibited complete absence of any smooth muscle contraction following MRS (DCI = 0). Having a small MSA implant (13 or 14 beads) versus a large MSA implant (15, 16 or 17 beads) trended towards an association with developing dysphagia (47% versus 29%, P-value 0.18). The DCI ratio of MRS/wet swallows that predicted development of dysphagia following MSA was 0.59.

CONCLUSION:

Intact peristaltic reserve, as assessed by augmented contraction following MRS, was protective of developing dysphagia following MSA. MRS should be given important consideration in the evaluation of patients under consideration for antireflux surgery specifically with regards to counseling patients on their individual risk of developing dysphagia and the potential need for additional procedures such as dilation.
434 Response to Multiple Rapid Swallows Shows Impairment of Inhibitory Pathways in Patients With Distal Esophageal Spasm
Authors: Hernandez Patricia V. , Valdovinos-Garcia Luis R. , Horsley-Silva Jennifer L. , Valdovinos-Diaz Miguel A. , Crowell Michael D. , Vela Marcelo F.
Published: October 2019

INTRODUCTION:

Distal esophageal spasm (DES) is a motility disorder characterized by premature contraction of the esophageal body during single swallows. It is thought to be due to impairment of esophageal inhibitory pathways, but studies to support this are limited. Assessment of response to multiple rapid swallows (MRS) during high-resolution esophageal manometry (HRM) enables detection of impaired inhibition during MRS. Healthy subjects respond to MRS by deglutitive inhibition during the MRS sequence. We hypothesize that deglutitive inhibition is impaired in DES patients. Aim: compare response to MRS in DES patients and healthy controls.

METHODS:

Response to MRS was evaluated in 19 DES patients and 24 asymptomatic healthy controls. Demographic and symptom data were extracted from a prospectively maintained motility database. Patients with history of prior gastroesophageal surgery, endoscopic myotomy (POEM), pneumatic dilation, esophageal botulinum toxin injection within 6 months of HRM, and esophageal stricture were excluded. HRM was performed with a solid state catheter with 36 circumferential pressure sensors 1-cm apart; ten 5-ml liquid swallows were given followed by MRS sequence, analyzed with Manoview software (Medtronic). Esophagogastric junction integrated relaxation pressure (IRP), distal contractile integral (DCI), and distal latency (DL) were calculated, and Chicago Classification v3.0 was applied to diagnose DES (defined by ≥ 2 swallows with DL ≤ 4.5 sec). Response to MRS was evaluated for complete versus impaired inhibition (contractility with DCI > 100 mmHg-sec-cm during MRS), and presence of post MRS contraction augmentation (DCI post MRS greater than single-swallow mean DCI). Chi-Square and Fisher’s exact test were used for statistical analysis.

RESULTS:

Demographics and symptom data are shown in Table 1. Patients with DES were older and more symptomatic than controls. Impaired inhibition of peristalsis during MRS was significantly more frequent in DES compared to controls (89% vs 0%, P < 0.001, Figure 1). The proportion of subjects with augmentation post MRS was similar for both groups (37% vs 38%, P = 1.00), but mean DCI post MRS was higher in DES than controls (3788 vs 1239, P = 0.013).

CONCLUSION:

Impaired deglutitive inhibition during MRS is present in the majority of patients with DES, supporting impaired inhibitory pathways in the esophagus as a mechanism of action in this disorder.
438 Seasonal Variations in Eosinophilic Esophagitis Related Hospitalizations: A Multiyear Analysis From the Largest Inpatient United States Database
Authors: Gupta Kamesh , Khan Ahamd , Sohail Abdullah , Bansal Pardeep , Goyal Hemant
Published: October 2019

INTRODUCTION:

Seasonal variations have been reported in the exacerbation of the eosinophilic esophagitis (EE), but there is conflicting data with no clear consensus. The pathogenesis of EE is believed to be immune/allergen mediated, including aeroallergens. This would support the theory of seasonal variations as other allergic conditions like asthma have been also shown to peak in Autumn. The purpose of our study is to analyze the seasonal variations in EE-related hospitalizations and hospital charges.

METHODS:

We conducted a cross-sectional study using the National Inpatient Sample (2008 to 2014), which is the largest US inpatient database. We used ICD-9-CM code (K200) to identify cases with a primary diagnosis of EE. Seasons were defined as follows: Winter (December-February); Spring (March-May); Summer (June–August); Autumn (September–November). The number and proportion of hospitalizations along with other outcome variables like mortality, length of stay (LOS) and hospitalization charges were compared and adjusted odds ratio for the outcome variables with regression analysis accounting for these confounders: age, gender, race, comorbidities, LOS, admission status and hospital factors including location and teaching status. All statistical analyses were performed with STATA.

RESULTS:

A total of 10,856 hospitalizations with a primary diagnosis of EE were reported between 2008 and 2014. Mean age of the population was 25.76 ± 0.78 years, and 34% were females. The highest number of EE-related hospitalizations were reported in summer (N = 2775; 25.5%) followed by winter (N = 2766; 25.4%), Autumn (N = 2749; 25.32%) and the least in spring season (N = 2565; 23.6%). In-hospital death was recorded in only 5 cases (0.04%). Mean length of stay was highest in the Spring as compared to the mean LOS for all seasons (3.73 vs. 3.30 days; P = 0.004). Hospitalization charges were highest in spring ($26403) versus a mean of $24826 over all four seasons (P = 0.336).

CONCLUSION:

We did not observe any statistically significant seasonal pattern in the number of EE-related hospitalizations. However, patients admitted during Spring (March, April, May) had significantly longer LOS. Economic costs per hospitalization were also highest in spring but were not statistically significant. This study is limited in that the analysis is based on the accuracy of diagnostic codes reported at the time of hospitalization.
443 Adjunctive Yield of Wide-Area Trans-Epithelial Sampling With Computer-Assisted Three-Dimensional Analysis in Detection of Dysplasia After Advanced Imaging and Random Biopsies in Barrett’s Esophagus
Authors: Raphael Kara L. , Stewart Molly , Sejpal Divyesh , Cheung Mary , Whitson Matthew , Han Dennis , Benias Petros , Lee Calvin , Miller Larry , Trindade Arvind
Published: October 2019

INTRODUCTION:

Wide-area trans-epithelial sampling with computer-assisted three-dimensional analysis (WATS-3D) has been used for dysplasia detection in endoscopic surveillance of Barrett’s esophagus (BE). Little is known about the additive yield of WATS after a thorough exam with advanced imaging that consists of high definition white light endoscopy (HDWLE), narrow band imaging (NBI), volumetric laser endomicroscopy (VLE) with laser marking, and Seattle protocol biopsies (collectively termed HDWLE-NBI-VLE-SP exam). The aim of this study was to evaluate the adjunctive yield of WATS-3D after an HDWLE-NBI-VLE-SP exam.

METHODS:

This is a single center observational cohort study from January 2017 to December 2018. Charts were abstracted for consecutive patients that underwent an advanced imaging exam. Raised lesions were removed by endoscopic resection. Areas suspicious for dysplasia on NBI and VLE were biopsied or resected. This was followed by random biopsies. Finally WATS-3D brush biopsies were performed.

RESULTS:

One hundred and thirty eight cases were included in this study. Thirty-five cases (25% of the total ) were identified as some degree of dysplasia on the HDWLE-NBI-VLE-SP exam. Of these, 14 were reported as indefinite for dysplasia, 11 low-grade dysplasia (LGD), 8 high-grade dysplasia (HGD) or intramucosal cancer, and 2 T1b cancers. Adjunctive use of WATS-3D yielded an additional 12 new cases of dysplasia (9 with crypt dysplasia and 3 with LGD), for added yield of 34.3% (=12/35, 95% CI 14.6-62.2%). In addition, 8 cases of dysplasia found on the HDWLE-NBI-VLE-SP exam were upgraded by WATS-3D to a higher grade of dysplasia (5 with crypt dysplasia and 3 with HGD). Thus the absolute increase provided by WATS was 8.7% (=12/138) for a new diagnosis of dysplasia and was 14.5% (=20/138) when combining both new and upgraded diagnosis of dysplasia grade.

CONCLUSION:

The addition of WATS-3D to an already thorough exam with HDWLE-NBI-VLE-SP can increase the yield of dysplasia detection.
445 A Comparative Study of Proton Pump Inhibitor’s Prescription According to Clinical Practice Guidelines Between a Private Clinic and a Public Hospital in Lima, Peru
Authors: Granda Camila , Martel Mariana , Ticse Ray , Pinto Jose , Espinoza-Ríos Jorge
Published: October 2019

INTRODUCTION:

The use of proton pump inhibitors (PPI) for the treatment of the upper digestive system diseases, had exponentially grown by 456% globally since the 1990’s. They lower the gastric acid production by inhibiting the H+/K+/ATPase from the gastric parietal cells. Despite being considered relatively safe, studies have arised associating them with nutrient malabsorption, gastroenteritis, diarrhea caused by Clostridium difficile, fractures and renal failure. The objective of this study is to determine the frequency of adequate prescription of PPIs comparing a public hospital and a private clinic in Lima, Peru.

METHODS:

A descriptive cross-sectional study was developed in which data was collected from the clinical files of hospitalized patients and was registered on a checklist created by the guidelines from the FDA, AGA, ACG and ASHP, and categorized on whether they were adequately prescribed by following the guidelines or not. The study included patients older than 18 years old who had received at least one PPI while hospitalized in the services of internal medicine and general surgery of a public hospital and a private clinic in Lima, Perú. The exclusion criteria are patients who consumed PPIs within 2 weeks of the hospitalization or patients who had been in critical care units.

RESULTS:

A total of 128 patients, 46% from the hospital and 54% patients from the clinic. An average age of 52 years and 25% of patients were older than 65 years with a male female ratio of 3:2. Comparing the service of internal medicine within both establishments the public hospital had better adherence to the guidelines (68.18%, 27.28%; P = 0.019) and comparing general surgery, the private clinic was more adequate (63.64%, 35.14%; P = 0.078).Within the hospital, medicine had a better adherence to the guidelines than surgery (68.18%; 35.14%). On the other hand, within the clinic the surgery presented a better adherence (63.64%; 27.28%).

CONCLUSION:

The high percentage of inadequate PPI prescription found in this study is similar to those found on other studies between public hospitals.The main reason for a prescription according to the guidelines was for gastric ulcer prophylaxis in patients older than 65 years old who were taking NSAIDs. The main reasons to not follow the clinical guidelines was polypharmacy (3 or more drugs) mainly on surgery in the hospital and on medicine in the clinic. The clinic has a more adequate prescription of PPI in surgery and lower in medicine compared to the hospital.
452 What Really Happens to Our Veterans With Achalasia?
Authors: Hasan Raza , Banerjee Promila , Sontag Stephen , Schnell Thomas , Leya Jack
Published: October 2019

INTRODUCTION:

Few studies have reported the outcomes of veteran patients with achalasia over a period of decades, and the role of surgical versus non-surgical management remain uncertain.

METHODS:

This study identified 66 patients confirmed by manometry from 2000-2017. All patients were from a single site, Veterans Affairs Hospital in Hines, IL. Patients were followed up to 18 years overall. These outcomes were examined; natural progression of disease, complications from the disease and mortality. Additionally, type of treatment, responses to treatment (performed by 3 endoscopists) and complications of treatment were recorded. Sustained response was defined as a decrease to Eckhardt score <4 for one year.

RESULTS:

Of the 66 patients, 5 patients were found to have external compression from malignancy, and there were excluded. Of the remaining 61 patients, 100% were male, 70.5% were white, and 29.5% were African-American. Mean age at diagnosis was 67 years old. Average follow up was 5.3 years. Of the 48 patients that received treatment, 62.5% received pneumatic dilation (PD), 43.8% received Botox injections, and 25% received Heller Myotomy (HM). Sustained response rates were superior in the PD group compared to the botox, 63.3% vs 42.9% (P 0.07), and PD group compared to HM 63.3% vs 41.7%, (P 0.10). In this group, the average number sessions was 2.1 for PD, 1.9 for botox, and 1.1 for HM. Overall response rate for all three modalities was 75% (n = 36). Complications were highest in the HM group with a rate of 25%. Further analysis of subgroups showed that risk factors of GERD, obesity and OSA did not affect treatment response rate, with overall treatment response rates of 85.7% for GERD, 100% for obesity, and 100% for OSA. Of the 13 patients who did not receive any treatment for achalasia, 69.2% continued to have symptoms; however none of these patients developed complications of aspiration, infection, food impaction or death.

CONCLUSION:

PD was superior to botox and PD was superior to HM in sustained response and complication rate. There was no statistical significant difference between any type of interventions verses no intervention; but this may be due to the small number of patients receiving HM.
458 Implementation and Analysis of an Online Esophageal Motility Curriculum for Gastroenterology Fellows
Authors: Kraft Cary , Ko Myung S. , Sewell Justin , Kathpalia Priya
Published: October 2019

INTRODUCTION:

Compared with endoscopic training, motility education of gastroenterology (GI) fellows is limited at many training centers. To better prepare fellows for treating patients with esophageal motility (EM) disorders, an understanding of EM is essential. Novel educational technology may facilitate dissemination of standardized curricula to train GI fellows at programs lacking strong motility presence.

METHODS:

A pretest survey assessing comfort level and baseline interpretation of EM studies was sent to UCSF GI fellows in July 2017. An online application called Qstream was then implemented which sent 1-2 questions per week out of a specially designed question bank. Questions, with detailed explanations, were repeated or retired depending on response accuracy. A post-curricular test was sent in June 2018 to gather quantitative and qualitative data. The Qstream software was also mined for data on correct responses across multiple attempts at answering questions. Analysis was performed using qualitative assessment of feedback from participants and comparative statistics using a paired- t test with unequal variance and Chi-square test.

RESULTS:

Nine trainees completed a pretest survey and 6 trainees completed the posttest. Initially, only 33.3% of fellows were comfortable in interpreting EM studies, whereas following the curriculum 83.3% felt comfortable in their abilities (P = 0.097). Trainees' accuracy in interpreting and answering clinical questions increased from 77.8% to 80% on the posttest (P = 0.43). However, when using data obtained directly from the Qstream software, there was relative improvement (26.9%) from fellows' first attempt at answering questions to their final attempt. Trainees found the following aspects of the curriculum to be valuable: the ease of usability of the online questions, the flexibility in pacing, and the real time explanations of questions.

CONCLUSION:

A technology based curriculum was effective and efficient in educating GI fellows on core concepts of EM. The online nature of the curriculum was critical in accommodating the busy clinical schedules of our trainees. Fellows reported increased comfort in interpreting EM studies after completing the curriculum; lack of improvement on the post-test likely reflects their high performance on the pre-test, which was not very complex. We plan to continue offering this curriculum with increasingly challenging questions to allow for further stratification of data and overall improved competency in EM among GI trainees.
460 High Rates of Loss to Follow-Up After Esophageal Food Impaction in Suspected Eosinophilic Esophagitis: Time to Standardize Care
Authors: Donohue Sarah , Hillman Luke , Lomeli Luis , Gaumnitz Eric
Published: October 2019

INTRODUCTION:

Esophageal food impaction (EFI) is often the first presentation for patients with eosinophilic esophagitis (EoE). Management of EFI when EoE is suspected lacks evidence-based guidelines. The goals of this study are to evaluate the biopsy rates, medical management, follow-up and recurrence of EFI in patients with suspected EoE.

METHODS:

Adult patients presenting with EFI between 2007-2017 were identified by ICD-9 (935.1) and ICD-10 (T18.1) codes for foreign body in the esophagus. Inclusion criteria required endoscopic intervention with documentation of suspected EoE: defined as endoscopic features of rings, furrows, edema or exudate.

RESULTS:

We identified 471 cases of EFI requiring endoscopic intervention, with 171 suspected to have EoE. The biopsy rate at time of EFI for patients with suspected EoE was 46%. When patients were not biopsied at time of EFI (n = 93), the majority were initiated on empiric therapy without histologic diagnosis: PPI (90%) and topical steroids (1%). Follow-up endoscopy was recommended in 97% of patients not biopsied at time of EFI and 32% (n = 27) were lost to follow-up. Empiric therapy after EFI did not impact the diagnostic yield at time of follow-up endoscopy (median: 36 days) as rates of diagnostic biopsy (≥15 eos/hpf) were similar compared to those biopsied at time of EFI (66% vs 65%, P = 0.612). Time to follow-up endoscopy did not impact diagnostic yield (P = 0.21). While on therapy, 16% of patients (n = 9) had low level esophageal eosinophilia (5-14 per hpf) on follow-up EGD (median: 29 days). Over the 11 year period, recurrent EFI occurred in 16 patients (3.4%) with a median time to recurrence of 1.65 years.

CONCLUSION:

EFI presents a unique opportunity to diagnose, treat and establish care for patients with EoE. Our study identified low rates of esophageal biopsy and high rates of loss to follow-up. Empiric therapy did not impact diagnostic yield on subsequent endoscopy with early follow-up. Low level eosinophilia while on therapy should be interpreted cautiously as this may represent partially treated disease. Although uncommon, EFI and recurrence are a disease defining event that create significant patient discomfort and require costly intervention. Our study highlights the need for standardize practice at the time of EFI when EoE is suspected including a structured system to streamline outpatient care, avoid loss to follow up and ultimately, prevent long term complications from this chronic disease.
462 A Retrospective Review of Effervescent Granules and Glucagon for the Management of Esophageal Food Impactions in a Community Hospital
Authors: Beattie Michael , Mansour Ramy , Minaudo Mark
Published: October 2019

INTRODUCTION:

Esophageal food impaction is one of the more common GI emergencies. While endoscopy is the definitive therapy, pharmacologic therapy does have a role. Despite minimal success, because of the safety profile glucagon is currently recommended as the initial pharmacologic therapy.1–5 Effervescent agents have been limited due to previous concerns of perforation, but studies have been revisited recently with safety and success.5–7 Our aim is to measure EG and glucagon as a primary pharmacologic agent.

METHODS:

A retrospective study was performed on all patients over 18 between 6/2015-5/2018, with diagnosis of esophageal obstruction or foreign body. Exclusion was transfer to outside facility. Records were reviewed for administration of glucagon and/or effervescent granules, if relief of obstruction was achieved, patient's ability to tolerate secretions and food responsible. Etiology was determined from history, endoscopy report, imaging, and pathology. T-test was performed for statistical significance.

RESULTS:

Demographic data, along with food bolus types and diagnoses can be found in Table 1. EG was attempted as an initial modality in 20.2% of cases and glucagon in 16.8%. EG was more successful when compared to glucagon (51.2 % vs 14.7%) (P = 0.0216). EG was successful as secondary modality in 75% of cases after glucagon initially failed, as compared to glucagon in 0% (0/9) of cases when EG initially failed (P = 0.0094). Figure 1 highlights success of EG and Glucagon based on diagnosis. There were no major safety events.

CONCLUSION:

Overall, EG is safe; and appears to overall be more efficacious than glucagon as initial pharmacologic therapy for EFI. This is a worthwhile therapy for both those who are tolerating secretions and those who are not, while glucagon seems to be more effective for secretion tolerant patients. EG was highly successful in patients tolerating secretions, however with a success rate of over 50% with no complications, we suggest it is worth attempting even in those who are not.
468 Effects of Eluxadoline on a Range of Bowel and Abdominal Symptoms in Patients With Irritable Bowel Syndrome With Diarrhea who Report Inadequate Symptom Control With Loperamide
Authors: Brenner Darren M. , Sayuk Gregory S. , Elmes Steven J. R. , Saeed Mazen , Chey William D.
Published: October 2019

INTRODUCTION:

The efficacy and safety of eluxadoline (ELX), a US Food and Drug Administration-approved mixed μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist for treating adult patients with irritable bowel syndrome with diarrhea (IBS-D), were evaluated in patients who self-reported inadequate response to loperamide in the RELIEF trial. Radar plots were generated from these results to interpret improvements across a spectrum of efficacy measures in ELX-treated patients.

METHODS:

A Phase 4, multicenter, placebo (PBO)-controlled, double-blind study randomized patients with IBS-D (Rome III criteria) with intact gallbladders who reported overall inadequate IBS symptom control with loperamide in the preceding 12 months to oral ELX (100 mg twice daily) or PBO for 12 weeks (RELIEF; NCT02959983). Patients rated IBS symptoms including worst abdominal pain (WAP), abdominal bloating, abdominal discomfort, stool consistency, number of bowel movements (BMs), and urgency episodes daily. Adequate relief of IBS symptoms was assessed weekly. Response rates over Weeks 1–12 and change from baseline to Week 12 were graphed using radar plots for the following endpoints: primary efficacy composite response (simultaneous daily improvement of ≥40% in WAP score vs. baseline and Bristol Stool Form Scale score <5 [or no BM] on ≥50% of treatment days); stool consistency response as per the primary endpoint; urgency-free response calculated using criteria of ≥50% or ≥75% of days with no urgency episodes; adequate relief response defined as a weekly “yes” response for ≥50% of treatment weeks; WAP response calculated using criteria of ≥30%, ≥40%, or ≥50% improvement vs. baseline.

RESULTS:

In this study cohort, baseline symptom scores were similar between the treatment groups (Table 1). Significantly higher proportions of ELX-treated patients were composite, stool consistency, and ≥30%, ≥40%, and ≥50% WAP responders vs. PBO at Week 12 (Figure 1). A greater proportion of ELX- vs. PBO-treated patients were also urgency-free and adequate relief responders. ELX-treated patients experienced greater improvements from baseline in WAP, abdominal bloating and discomfort, BM frequency, and urgency episodes vs. PBO (Figure 2).

CONCLUSION:

Across 13 endpoints, ELX treatment led to improvements vs. PBO, indicating efficacy across a multitude of IBS-D symptoms among patients with prior inadequate symptom control with loperamide.
474 Activated Duodenal Eosinophils Are Associated With Early Satiety-Predominant Functional Dyspepsia: Results From a U.S. Veteran Cohort
Authors: Sparkman Jordan , Damron Alexander , Green Linda K. , Rosen Daniel , Graham David Y. , El-Serag Hashem B. , Jarbrink-Sehgal Maria
Published: October 2019

INTRODUCTION:

Functional Dyspepsia (FD) is unexplained epigastric discomfort, early satiety or postprandial distress for three months. FD affects 50% of care-seeking Veterans in the United States. Diagnosis of FD is based on Rome consensus symptom criteria as no objective markers exist. There is interest in duodenal eosinophilia as a driver of FD symptoms, however heterogeneity among recent studies has produced divergent results. A “normal” range of duodenal eosinophil counts should be established. The influences of a personal history of atopy, medication use and seasonal variation effects on duodenal eosinophil counts and their relation to FD symptoms are poorly studied.

METHODS:

This is a cross-sectional study from the Michael E. DeBakey VA Medical Center in Houston, Texas utilizing a well described cohort. Exclusion criteria included malignancy, H. pylori, celiac disease, parasite infection, eosinophilic gastroesophagitis and others. FD was defined by survey-derived Rome II symptom criteria. Medication use was obtained through chart review. Histopathology was independently reviewed by two blinded observers.

RESULTS:

460 patients were included in the present study. There was good observer agreement on duodenal eosinophil counts. Duodenal eosinophilia was defined as ≥62 per 5 HPF. Patient characteristics grouped by presence or absence of duodenal eosinophilia are found in Table 1. Mean eosinophil counts grouped by various items are included in Table 2. 182 patients had FD (39.6%) and were younger (58 vs 60.2 years of age, P = 0.01) and more likely to be on a PPI and H2RA (P = 0.03, P = 0.02) compared to controls. Eosinophil degranulation was present in 101 (22.0%) patients and was associated with FD (OR 1.84, 95% CI 1.15-2.94, P = 0.01), specifically early satiety symptoms (OR 2.15, 95% CI 1.33-3.47, P = 0.002) but not epigastric pain (P = 0.62). Samples collected in the fall had significantly lower mean duodenal eosinophils per 5 HPF (55.1) than those collected in the spring (82), summer (73.2), or winter (76.2) months.

CONCLUSION:

In this large, adult, and diverse VA study, duodenal eosinophilia, defined as counts ≥62 per 5 HPF, was common (50.2%). While we could not confirm an association between duodenal eosinophilia and FD in our patient cohort, a positive association between the presence of activated duodenal eosinophils and FD, specifically early satiety-predominant FD, was found. This supports the inflammatory hypothesis of FD, albeit more proximally in the cascade.
485 Evaluation of Somatic Pain Distribution Using Body Maps for Patients With Chronic Abdominal Pain Syndromes
Authors: Aivaliotis Vasiliki I. , Hah Jennifer M. , Pirrotta Luke , Nguyen Linda A.
Published: October 2019

INTRODUCTION:

Chronic abdominal pain (CAP) is a widespread condition with a large impact on the healthcare field. Understanding the characteristics of patients with CAP and identifying high risk patients remains an important issue, particularly in the opioid epidemic era. A body map is a validated tool shown to accurately depict pain locations across the body. Our aim was to use body map data to characterize the pain distribution patterns of patients referred for abdominal pain to the Stanford Pain Clinic and to assess whether patterns of pain distribution (e.g. localized abdominal pain vs. widespread pain) are associated with underlying diagnoses and differences in psychosocial functioning.

METHODS:

We evaluated patients with CAP who presented to the Stanford Pain Clinic between 2013-2018. Data was collected through the CHOIR registry - a platform that longitudinally collects data for patients seen at our pain clinic. Patients were divided into 3 groups by their body map response: Localized (abdominal pain), Intermediate (abdominal pain + pain at 1-3 additional sites), and Widespread (abdominal pain + pain at 4-8 additional sites). We evaluated demographics, ICD-codes, and psychosocial functioning with NIH PROMIS questionnaires. Analysis was performed using descriptive statistics, one-way ANOVA for the PROMIS scores, and the Kruskall-Wallis test for comparing measures across the 3 groups.

RESULTS:

A total of 258 patients with abdominal pain were identified through the CHOIR registry. The majority of the patients were female (91%) and had widespread pain patterns (61%). Patients with widespread pain patterns reported higher pain interference (P < 0.01), anxiety (P < 0.05), and sleep disturbances (P < 0.01) compared to the intermediate pain group. Patients with widespread pain were more likely to carry a diagnosis of 2 or more chronic overlapping pain conditions (P < 0.001). Opioid use remained high in all patients, regardless of somatic distribution pattern.

CONCLUSION:

Our study supports that a body map is an effective and quick screening tool to help characterize CAP patients and identify higher risk patients. Identifying patients with widespread pain patterns early may help guide therapeutic interventions towards factors more prominent in this group such as pain interference, anxiety and sleep disturbance. Patients with widespread pain patterns are more likely to also suffer from chronic overlapping pain syndromes and should be screened for these conditions.
486 Social Media Use in Irritable Bowel Syndrome Patient Education: A Content Analysis of YouTube Videos
Authors: Zheng Xin , Fan Xiaowen , Wright Andrew P. , Kim John , Zhao Yan
Published: October 2019

INTRODUCTION:

Irritable bowel syndrome (IBS) affects around 11% of the population globally and often associated with lower quality of life. The diagnostic challenges and myths surrounding IBS further drive patients to seek additional information via social media platforms such as YouTube. This study performs a multi-dimensional analysis of the most viewed IBS videos on YouTube using the DISCERN scoring system. The goal of this study is to determine the overall validity, breadth and depth of IBS knowledge delivered to patients seeking IBS information on YouTube.

METHODS:

The multi-dimensional content analysis includes two parts. Part I consists of a general search using keyword “IBS”. The 30 most viewed videos were reviewed individually for their information on IBS diagnosis, symptoms, treatment and prognosis. Part II focuses on the 10 most viewed videos and 3 board certified gastroenterologists undergo a detailed content analysis using the validated DISCERN scoring system (1- low quality to 5 – high quality) and further validated the contents against the current practice guidelines and consensus.

RESULTS:

Of the 30 top viewed IBS videos, 60% (n = 18) were made by for-profit websites or companies (total 5.28 million views), 23.33% (n = 7) came from scientific and medical institutions (total 2.54 million views), and 16.67% (n = 5) were personal commentaries and experiences (total 1.14 million views). Videos made by scientific institutions have the highest average number of views per video. The average DISCERN score for overall quality of the top 10 videos was low-intermediate quality (2.38 out of 5). Low quality videos have a total views three times more than those of intermediate quality (3.67 million vs. 1.25 million). These videos score relatively high (>3) on items relating to the benefits of their proposed treatment but low on item relating to the risks of each treatment.

CONCLUSION:

In this study, the overall quality of YouTube's most viewed videos on IBS treatment have a collectively low-intermediate quality. They often avoid discussion on the risks of their proposed treatment option. The number of views also does not necessary correlate with quality. Videos made by for-profit organizations have total view counts much higher than videos made by reliable medical institutions, likely because they are more invested in advertising and have more videos. The medical community will need to collectively deliver better quality and more YouTube video for the purpose of IBS patient education.
494 The Fragility of Randomized Placebo-Controlled Trials for Irritable Bowel Syndrome Management
Authors: Williams Mary-Jane O. , Dennis Brittany , Dlamini Vanessa , Nwaiwu Obioma , Nguyen Linda A. , Okafor Philip N.
Published: October 2019

INTRODUCTION:

Fragility indices (FI) are a novel method to measure the robustness of results in clinical trials. The FI represents the number of participants whose status in a clinical trial would have to change from a non-event (not experiencing the primary endpoint) to an event (experiencing the primary endpoint) to turn a statistically significant result into a non-significant result. The aim of this study was to evaluate the robustness of trials for irritable bowel syndrome (IBS) including IBS-mixed, IBS-constipation, and IBS-diarrhea.

METHODS:

Trials published in high impact journals comparing the efficacy of therapies for IBS were identified from Medline. Trials had to be in adults, randomized, parallel-armed, with at least one statistically significant (P < 0.05) binary outcome, and a positive result (i.e. primary endpoint met). Only primary endpoints of therapeutic efficacy were considered. Only trials comparing Rifaximin, Eluxadoline, fecal microbiota transplant (FMT), probiotics, Ramosetron, Alosetron, physical activity, Cimetropium and Pinaverium to placebo met the inclusion criteria. FI and correlation coefficients were calculated and regression modeling was also used to identify predictors of a high FI.

RESULTS:

Thirteen trials meeting the inclusion criteria were analyzed. The impact factor of the journals in which they were published ranged from 3.5-79. The median FI was 6 (range 1-38). The median sample size in all trials was 427 (range: 44-1280). The trial publication year (P = 0.60), journal impact factor (P = 0.16), time point in weeks when the primary outcome was assessed (P = 0.45), duration of the study (P = 0.89), and number needed to treat [NNT] (P = 0.06) were not predictive of a high FI. However, a larger sample size was predictive of a higher FI (P = 0.01). The highest FI was seen in a Ramosetron trial (FI = 38) for IBS-D published in Gastroenterology. No correlation was seen between FI and journal impact factor (R = 0.19, P = 0.55), trial publication year (R = 0.09, P = 0.77), duration of trial (R = -0.45, P = 0.12), time point at which the primary endpoint was assessed (R = -0.12, P = 0.70), NNT (R = -0.34, P = 0.26), and sample size (R = 0.22, P = 0.47)

CONCLUSION:

Our results suggest that a median of six participants is needed to nullify efficacy outcomes in the included IBS therapy trials. A larger sample size was predictive of a high FI. Some trials used in the formation of evidence-based guidelines are fragile suggesting how easily statistical significance based on a threshold P-value may be overturned.
496 Baseline and Longitudinal Microbial Changes Predict Response to Rifaximin and/or Diet Low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols in Irritable Bowel Syndrome
Authors: Lee Allen , Rao Krishna , Haller Emily , Van Dam Lauren , Baker Jason , Watts Lydia , Eswaran Shanti , Chey William D. , Owyang Chung , Young Vincent , Hasler William
Published: October 2019

INTRODUCTION:

Diarrhea-predominant irritable bowel syndrome (IBS-D) is a chronic, disabling condition. Treatments for IBS-D, including rifaximin, a nonabsorbable antibiotic, and a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP), improve symptoms in ≤50% of patients. We hypothesized that changes in the gut microbiota predict response to treatment for IBS-D.

METHODS:

We randomized 17 patients meeting Rome IV criteria for IBS-D to receive either rifaximin 550 mg three times daily x 14 days or a low FODMAP diet x 4 wks. The primary outcome was proportion of responders to intervention defined by ≥30% improvement in mean daily abdominal pain or bloating scores. The secondary outcome was ≥50-point decrease in IBS-Severity Symptom Scoring (IBS-SSS) compared with baseline. Fecal samples were collected at baseline and 2, 4 and 5 wks. The microbial community in these specimens was characterized by 16S rRNA encoding-gene sequence analysis.

RESULTS:

There were 6 subjects (60.0%) in the rifaximin group and 4 subjects (57.1%) in the low FODMAP group that met the primary endpoint (P > .99) (Table 1). Patients in the rifaximin group had significant improvements in abdominal pain (P = .01), bloating (P = .02), and IBS-SSS (P = .009) compared with baseline. Patients in the low FODMAP group showed improvement in IBS-SSS only (P = .06) at the end of treatment. Responders to treatment had unique inter- and intra-individual temporal characteristics compared with non-responders. Responders to rifaximin and low FODMAP diet showed a distinct microbial community structure at baseline compared with non-responders (P = .001 for both, Figure 1A). Responders to rifaximin (P = .08) and low FODMAP diet (P = .01) also exhibited lower degrees of microbial community change during therapy compared with non-responders (Figure 1B). Responders to rifaximin (Figure 2A) and low FODMAP diet (Figure 2B) showed changes in several taxa at baseline and longitudinally compared with non-responders.

CONCLUSION:

Responders to therapy with rifaximin and low FODMAP diet show a distinct fecal microbial community structure at baseline. Many microbiome features at baseline predict response to treatment. Longitudinal analyses show responders have a more resilient community structure to either rifaximin or dietary modification compared with non-responders. The functional significance of these microbial changes in responders vs. non-responders is unclear, but may be the focus of future studies.
505 24-Month Post-Marketing Safety Surveillance Data of Caraway Oil and L-menthol With Site Specific Targeting (COLM-SST): A Novel Formulation for FD
Authors: Lacy Brian E. , Epstein Michael S. , Shah Syed , Corsino Patrick
Published: October 2019

INTRODUCTION:

Functional Dyspepsia (FD) is a common functional GI disorder in the upper abdomen (above the navel). The estimated prevalence is 15-30% worldwide. There are currently no FDA-approved medications for the treatment of FD. Proton pump inhibitors (PPIs) are commonly prescribed off-label. However, long-term use of these drugs has been associated with serious health concerns. Prokinetic agents are also often used off-label. However, many are associated with significant side effects (e.g. metoclopramide). A safe, effective, and readily available treatment option for FD is greatly needed. This study describes an important 24-month post-marketing point on an option for FD that has already demonstrated good efficacy and low side effects in RCTs. These RCTs have demonstrated that the combination of caraway oil and peppermint oil improves FD symptoms. Caraway oil plus L-menthol (the major component of peppermint oil) with site-specific targeting (COLM-SST) is a novel delivery system of triple-coated, solid-state microspheres designed to target the duodenum, the main center of disturbance in FD. This study was conducted to report on the overall safety profile of COLM-SST and to determine if any unexpected pattern of side effects emerged.

METHODS:

A call-in number for reporting adverse events (AEs) was provided on all boxes containing COLM-SST. An independent call center with pharmacovigilance-trained health care personnel, in accordance with the FDA and global regulatory guidelines on properly reporting AEs, was retained to receive and record customer AEs. The AEs for this study were collected and processed from July 8, 2016 to July 8, 2018.

RESULTS:

An estimated 558,345 individual patients used COLM-SST during the surveillance. An analysis of the data showed that there were no serious AEs reported. Additionally, the self-reporting rate of non-serious AEs was low, with only 148 events received (from 127 patients), a 0.023% event rate for COLM-SST. The top reported, non-serious AEs were abdominal pain/discomfort/distension (18; 0.0032%), which were consistent with the pattern of commonly reported symptoms of FD, and headache (7; 0.0013%).

CONCLUSION:

24 months of monitoring in-market, real-world use of caraway oil and L-menthol with site-specific targeting, for the treatment of FD demonstrates an extremely low rate of self-reported AEs. These data, combined with earlier RCT data, indicates that COLM-SST is a safe and effective therapy for FD, and is a viable alternative to PPIs and prokinetics.