bluuebunny/crossref_metadata_2025 huggingface dataset:
350 Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis in Adolescents and Adults: Results From a Phase 3, Randomized, Placebo-Controlled Trial
Authors: Hirano Ikuo , Collins Margaret H. , Katzka David A. , Mukkada Vincent A. , Falk Gary W. , Williams James , Desai Nirav K. , Lan Lan , Morey Robin , Dellon Evan S.
Published: October 2019

INTRODUCTION:

Eosinophilic esophagitis (EoE) is a chronic immune-mediated disease for which there is an unmet clinical need for new therapies. The safety and efficacy of budesonide oral suspension (BOS) for the treatment of EoE has been demonstrated in a previous phase 2 study. The current phase 3 study evaluated the efficacy and safety of BOS in a large cohort of patients with EoE.

METHODS:

This randomized, double-blind, placebo-controlled trial (SHP621-301; NCT02605837) investigated the safety and efficacy of BOS in patients (11–55 years) with EoE and dysphagia. Patients were randomized 2:1 to 2.0 mg BOS or placebo twice daily (b.i.d.) for 12 weeks (Figure 1). Co-primary endpoints were histologic (peak eosinophil count ≤6 eosinophils/high-powered field [eos/hpf]) and dysphagia symptom (≥30% decrease in symptoms as measured by the Dysphagia Symptom Questionnaire [DSQ]) responses after 12 weeks of therapy. Secondary endpoints included change in DSQ score and change in EoE Endoscopic Reference Score (EREFS) from baseline to final treatment period. Safety was also assessed.

RESULTS:

A total of 322 patients were randomized (BOS, n = 215; placebo, n = 107), of whom 318 patients received at least one dose of double-blind therapy (BOS, n = 213; placebo, n = 105) (Table 1). The primary outcomes were achieved, with significantly more histologic and symptom responders in the BOS-treated than the placebo-treated group (53.1% vs 1.0%, P < 0.001; 52.6% vs 39.1%, P = 0.024, respectively; Figure 2). Improvements in mean DSQ score from baseline to week 12 were significantly greater in the BOS group (n = 197) than the placebo group (n = 89) (−13.0 vs −9.1; P = 0.015). Similarly, improvements in mean EREFS scores were significantly greater with BOS (n = 202) than placebo (n = 93) (−4.0 vs −2.2; P < 0.001). In total, 61.0% of patients reported a treatment-emergent adverse event (TEAE) (BOS, 61.0%; placebo, 61.0%). Only 2.5% of patients experienced a TEAE leading to dose discontinuation (BOS, 1.4%; placebo, 4.8%). Few patients had severe or serious TEAEs on BOS or placebo. No life-threatening TEAEs were reported.

CONCLUSION:

This phase 3 trial demonstrated the efficacy of BOS as induction therapy for EoE. BOS resulted in significant improvements in histologic, symptomatic and endoscopic endpoints compared with placebo. The majority of TEAEs were mild to moderate and comparable between placebo and BOS. A double-blind, placebo-controlled maintenance study (SHP621-302) is ongoing.
354 Cumulative Increase in the Prevalence of Esophageal Cancer in Patients With Gastroesophageal Reflux Disease (GERD) and Multiple Risk Factors
Authors: Alaber Omar A. , Chandar Apoorva K. , Cooper Gregory S. , Thota Prashanthi N. , Mansoor Emad , Chak Amitabh
Published: October 2019

INTRODUCTION:

The 2015 ACG clinical guidelines on Barrett’s esophagus (BE) recommend endoscopic screening for men with chronic and/or frequent GERD and two or more risk factors for BE or esophageal adenocarcinoma (EAC). However, the additive effect of these risk factors is not known. Our objective was to determine both the individual and combined effect of multiple risk factors on the prevalence of BE associated neoplasia.

METHODS:

Data were obtained from a commercial de-identified patient database (Explorys, IBM, Inc.) that integrates electronic health records from 26 major U.S. hospital systems from 1999 to May 2019. We identified adult patients (≥18 years) with chronic GERD for ≥5 years (having a GERD diagnosis from May 2014 to May 2019) using Systematized Nomenclature of Medicine - Clinical Terms (SNOMED-CT). Controls were defined as any patient in the Explorys database with chronic GERD, whereas cases were defined as those with chronic GERD and one or more additional BE/EAC associated risk factors per ACG guidelines such as male sex, smoking, age > 50 years, and Caucasian race. Odds ratios (OR) and confidence intervals (CI) for the ORs were calculated for the risk of association of each individual risk factor and with multiple risk factors combined.

RESULTS:

A total of 4,424,810 patients had GERD for ≥5 years. When compared to GERD controls, cases with GERD and obesity (BMI >30) had a 1.4 (95% CI 1.24 – 1.55) times higher odds of a primary neoplasm of the lower esophagus. Addition of each individual risk factor as described in Table 1 shows the incremental effect of these risk factors on development of primary neoplasm of the lower esophagus. With any three out of four risk factors (chronic GERD and age >50 + any three out of four associated risk factors), the odds of having a primary neoplasm of the lower esophagus increased to 6.26 (5.77 – 6.79) when compared to GERD controls.

CONCLUSION:

The incremental and strong association of multiple risk factors with primary neoplasm of the lower esophagus suggests a role for screening endoscopies when clinicians encounter GERD patients with multiple associated risk factors. Although this was a retrospective analysis that relied on diagnosis coding, and despite other limitations of Explorys such as lack of histology reports, and unavailability of family history of BE/EAC, our study further validates the utility of the 2015 ACG Barrett’s guidelines in everyday clinical practice.
359 The Critical and Often Disregarded Role of Surgery in Curing Anemia in Patients With Hiatal Hernia
Authors: Laliberte Anne-Sophie , Brandabur Jack , Baik Peter , Jackson Anee Sophia , Bograd Adam J. , Aye Ralph W. , Farivar Alexander , Louie Brian E.
Published: October 2019

INTRODUCTION:

During iron deficiency anemia evaluation, patients may be found to have a paraesophageal hernia (PEH). Current GI guidelines recommend iron supplements and proton pump inhibitors (PPIs). Surgical repair is not recommended despite evidence of cure in the surgical literature, even in the absence of Cameron’s lesions. We examine the patterns of care of patients with pre-existing anemia who had PEH repair. We hypothesize that a more robust correction of anemia will be achieved in patients undergoing surgery.

METHODS:

We performed a retrospective chart review of consecutives patients with anemia and hiatal hernia that underwent a surgical repair between 2005-2016 in our system. Normal hemoglobin (Hgb) was defined for females as 12 g/dL and males 13 based on W.H.O. criteria and assessed at diagnosis, preoperatively and postoperatively.

RESULTS:

We analyzed 116 patients who were predominantly females with type 3 PEH of which 52.6% had Cameron ulcers. (Table 1) After diagnosis, 24.1% were transfused, 52% started on iron supplements, 72% on PPIs and 10% on H2-blocker. Patients underwent 1.6 (IQR = 1-5) EGDs, 1.1 (IQR = 1-3) colonoscopies along with CT scans in 39% and capsule endoscopy in 16%. Median time from diagnosis to surgical referral was 381 days (IQR = 129-1332). All patients underwent laparoscopic hernia repair with a total fundoplication (90%), partial fundoplication (6%) or hernia repair only (4%). There were no mortalities. Only 16% experienced a morbidity with 5.6% being major. The mean Hgb at diagnosis was 9.79 in females and 10.9 in males. It increased to 11.1 and 11.4 with medical management. With the addition of surgical repair, it increased to 12.3 and 13.4 at short term follow up. This was sustained at 12.8 and 14.2 long term. (Figure 1) The Hgb was normalized in only 36% of patients after medical management. Comparatively, the Hgb normalized after surgical repair in 62% at short term and in 74% at long term. Patients without Cameron’s ulcers normalized in 62%. (Table 2) After surgery, 95% ceased iron therapy and 73% were free from PPIs.

CONCLUSION:

Anemia associated with a PEH improves with medical therapy, but the addition of surgery normalizes Hgb and seems durable at 4 years without additional medical therapy. We recommend that surgical repair should be an integral part in the treatment, regardless of the presence of Cameron’s ulcers.
362 Factors Associated With Esophagogastric Junction Outflow Obstruction and Spastic Esophageal Motility Disorders
Authors: Foromera Joshua , Jonas Daniel , Ross Kristina , Van De Voorde Zoe , Kaizer Alexander , Menard-Katcher Paul , Yadlapati Rena
Published: October 2019

INTRODUCTION:

Advances in high resolution manometry (HRM) have resulted in increasing identification of major esophageal motility disorders in addition to achalasia type I and II. These include esophagogatric junction outflow obstruction (EGJOO) and spastic esophageal disorders (SEDs) which include distal esophageal spasm, jackhammer esophagus, and type III achalasia. The aim of this study was to identify the prevalence of and factors associated with EGJOO and SEDs among patients referred for high resolution esophageal manometry.

METHODS:

This is a retrospective study of adult patients who underwent high resolution manometry at a single tertiary-care center between 1/1/14-11/1/18. The following data were collected through electronic health records: demographics, medical and surgical history, medications, endoscopic findings and manometry results. Patients diagnosed with normal esophageal motility, EGJOO or a SED according to Chicago Classification v3.0, without prior history of foregut surgery were included.

RESULTS:

Overall, 911 studies were performed during the study period: 293 (32%) normal motor function, 88 (10%) EGJOO and 44 (5%) SEDs (17 type III achalasia, 19 jackhammer esophagus, 8 distal esophageal spasm). Thus, 425 patients were included in the final analysis [95 (32%) male, mean age 55.8 years, mean body mass index 27.5 kg/m2]. Patients with SEDs or EGJOO were more likely to have comorbid hypertension (55% or 46% vs 32%; P = 0.02 or P = 0.05, respectively) when compared to patients with normal motility. Further, patients with EGJOO and SEDs were older (62.8 or 58.8 vs 53.7 years; P < 0.01 for both) and those with SEDs were more likely to use opiates (43% vs 20%; P = 0.01). Patients with SEDs and EGJOO were also more likely to have comorbid connective tissue disease (17.2% or 14.0% vs 9.7%; P = 0.09 for both) (Table 1).

CONCLUSION:

Among 911 patients who underwent high resolution manometry studies, 10% had EGJOO and 5% had SEDs. Those with EGJOO and SEDs were likely to be older and had comorbid hypertension. Further, connective tissue disorder was more common with EGJOO and SED. These results suggest that the underlying physiologic of spastic and obstructive esophageal motility disorders may be related to microvascular or connective tissue pathology.
363 Reducing Over-Prescription of Proton Pump Inhibitors at an Internal Medicine Residency Clinic
Authors: Scholl Amy , Onwe Ifeanyichukwu , Lee Andrew , Chou Edgar
Published: October 2019

INTRODUCTION:

Proton pump inhibitors (PPIs) are widely prescribed medications for the treatment of acid suppression for a variety of conditions. The American College of Gastroenterology recommends that the continued use of PPIs be re-assessed 8-12 weeks after the initial start of treatment, but unfortunately, PPIs tend to be prescribed for much longer than this. Our Quality Improvement project investigates the over-prescription of PPIs in an Internal Medicine Residency outpatient clinic. We created an intervention to decrease the inappropriate prescription of PPIs.

METHODS:

This is a prospective study of 150 patients in an outpatient setting and their use of PPIs over the course of a year. Patients had an active diagnosis of either gastroesophageal reflux disease or functional dyspepsia. We performed an educational session as well as an electronic-medical record reminder to tell residents to re-assess the continued use of PPI. Patients were re-assessed 5 months after the intervention. Primary endpoints were the overall number of patients prescribed PPIs, if they were being prescribed PPIs appropriately, and if residents were re-assessing patients’ symptoms and continued need for PPI.

RESULTS:

The final sample size was 133 patients. The average duration that patients were prescribed PPIs was 73.4 weeks, and there were 7.5% associated adverse complications noted. After the intervention, there was a 12.1% decrease in the number of patients prescribed a PPI. Before the intervention 30% (n = 40) of patients were appropriately prescribed a PPI, and this number increased to 39.1% (n = 52) after the intervention (P = 0.023). Before the intervention, 34.58% (n = 46) of patients had their symptoms re-assessed by residents, and this number increased to 47.3% (n = 63) after the intervention (P = 0.001).

CONCLUSION:

By educating residents on the proper use of PPIs and by placing alert reminders in patients’ charts, we observed a decrease in the overall number of prescriptions of PPIs in the outpatient clinic. After the intervention, the frequency of residents re-assessing patients’ symptoms and need for continued use of PPI as well as the overall number of patients appropriately prescribed PPIs increased. We were unable to determine which intervention had the greatest impact (educational session versus alerts) as both interventions were looked at at the same time. Future studies could expand on this by just studying one intervention to see what has the greatest effect on the prescription of PPIs.
372 An Automated, Quantitative Multiplex Immunofluorescence Assay Accurately Risk Stratifies Barrett’s Esophagus Patients With a Community-Based Diagnosis of Low-Grade Dysplasia at a Rate Comparable to Expert Pathologists
Authors: Frei Nicola , Konté Kadere , Bossart Emily , Zhang Yi , Critchley-Thorne Rebecca , Pouw Roos , Bergman Jacques
Published: October 2019

INTRODUCTION:

The majority of community-based LGD diagnoses are down-staged to non-dysplastic (ND) BE when reviewed by an expert pathologist, whereas patients with confirmed LGD have a 10% annual risk of progression to high-grade dysplasia (HGD) or cancer (Ca). Although recommended by guidelines, expert review is poorly defined, prone to observer variation, and not widely available. Recent studies suggest that an automated, quantitative multiplex immunofluorescence assay may identify NDBE patients with an increased risk of malignant progression. We investigated if this assay also allows objective risk stratification for cases with a community-based diagnosis of LGD at a rate comparable to expert pathologists.

METHODS:

A blinded nested case-control cohort was derived from the screening cohort of a randomized controlled trial of SUrveillance vs. RadioFrequency ablation (SURF) for BE patients with LGD. 60 patients with a community-based diagnosis of LGD of whom 30 progressed to HGD/Ca and 30 patients who did not progress were matched for age, sex and maximal BE length. All random biopsy levels of the baseline endoscopy were independently reviewed by 3 expert pathologists with an international reputation. All levels were additionally tested by a multiplex biomarker assay. The assay classifies patients into low-risk (LR), intermediate-risk (IR) and high-risk (HR) for progression to HGD/Ca within 5 years. A histological revision diagnosis of NDBE was considered as low- (LR), while indefinite for dysplasia (IND) and LGD were considered as high-risk (HR) for progression.

RESULTS:

60 BE patients (52 male), mean age 63 ± 9 years, were studied. Median time between baseline endoscopy and progression was 2.5 years (1.3-5.4). Accuracy, sensitivity and specificity of the biomarker assay vs. the 3 expert pathologists were 73% vs 72-77%, 66% vs 77-80% and 80% vs 63-77%, respectively. 20/26 (78%) patients classified as IR/HR by the biomarker panel and 69-77% classified as HR (IND/LGD) by the 3 expert pathologists progressed to HGD/Ca.

CONCLUSION:

A quantitative multiplex immunofluorescence assay risk stratified BE patients with a community-based diagnosis of LGD with an accuracy comparable to three renowned expert pathologists. The assay allows for automated, objective risk stratification which may be a practical and effective solution to the lack of standardization of expert pathology review of LGD as advocated by all guidelines.
374 Practice Patterns in Patients Admitted for Denovo Acute Food Impaction: A Multi-Center Retrospective Study
Authors: Cavaliere Kimberly , Berkowitz Joshua , Melnyk Janet L. , Raphael Kara L. , Chowdhury Pratik , Benias Petros , Cheung Mary , Trindade Arvind , Whitson Matthew , Josephs Joshua
Published: October 2019

INTRODUCTION:

Food impactions are a medical emergency for gastroenterologists. Despite their common occurrence, recent data shows high variability in self-reported practice patterns of how gastroenterologists approach food impactions. This may lead to delayed diagnosis and care for patients, particularly in eosinophilic esophagitis (EoE). There is limited data available assessing real life practice habits and recommendations based on endoscopic findings.

METHODS:

This is a multi-centered, single-system retrospective chart review of all patients admitted with de novo food impaction between Jan 2013 and Sept 2018. Data collected includes demographics, clinical, endoscopic, and discharge recommendations. Patients with diagnosis of achalasia, EoE, malignancy, or stricture were excluded. Our primary aim was to characterize GI practice habits and discharge planning. A planned secondary analysis comparing practice habits in patients with and without presumed EoE was done.

RESULTS:

199 patients were admitted with food impaction during the study period, 157 meeting inclusion criteria. 36 had endoscopic features of EoE, with 33 having EoE as the presumptive diagnosis. 109 had a food bolus present on endoscopy. To remove this bolus, the ‘push through’ method was used in 29.9% of cases, roth nets in 26.1%, and graspers in 22.9%. On sub-group analysis, there was no statistical difference regarding endoscopic technique between those with and without presumed EoE. Esophageal biopsy was obtained in 40.1% of cases, but in 75.8% of patients with presumed EoE vs. 32.0% without (P ≤ 0.001) . At discharge, 79% of patients were started on a proton pump inhibitor (PPI), 43.9% were instructed to have a follow up endoscopy, with providers more likely to both start a PPI (P = 0.01) and refer for follow up (P = 0.02) if EoE was suspected.

CONCLUSION:

We conducted a multi-center, single-system study on the real life practice of gastroenterologists evaluating patients with de novo food impaction. EoE was suspected in 33 patients with a confirmed diagnosis in 63.6%. Push technique continued to be used as frequently in patients suspected of having EoE. Only 78.8% of patients underwent esophageal biopsy and 93% were started on PPI, though both statistically more frequent in patients with suspected EoE. There remains room for quality improvement in the treatment of de novo food impactions in patients suspected of having EoE and those who are not. A standardized protocol for food impactions would facilitate prompt diagnosis and treatment.
376 Persistent GERD Symptoms Despite PPI Treatment - Prevalence and Patient Characteristics: Results From a Cross-Sectional Patient Survey
Authors: Taylor Douglas C A , Chen Yan , Hanlon Jennifer , Morlock Robert , Morlock Amy , Howden Colin W.
Published: October 2019

INTRODUCTION:

GERD is a common disorder often treated with proton pump inhibitors (PPIs). However, many patients experience persistent GERD symptoms despite PPI treatment. The objective of this study was to estimate the prevalence of persistent GERD symptoms despite PPI treatment and to describe the characteristics of these patients in the US adult population.

METHODS:

The Acumen Health Research Institute survey is a cross-sectional health survey of US adults in which a subgroup of participants self-identified as having GERD (GERD patients). Participants aged ≥ 18 years were recruited in 2018 using sampling framework that ensured a composition representative of the US population. Patients were asked about their GERD history, treatments, and symptoms using the GERD Symptom Assessment Scale. Health-related quality of life (HRQoL) was assessed using the Veterans RAND 12-item (VR-12) physical component summary (PCS), mental component summary (MCS), and health utility (VR-6D). Work productivity and sleep disturbance due to GERD were also assessed. Persistent GERD was defined a priori as the presence of bothersome symptoms on at least 2 days in the preceding week despite taking PPIs for at least 25 days per month. Effectiveness of PPI treatment was rated as “a little” or “a lot.” GERD patients with and without persistent GERD symptoms were compared using descriptive statistics.

RESULTS:

Of 12,348 survey respondents, 1566 (12.7%) self-identified as GERD patients; 855 (54.6%) reported taking PPIs. Of those, 301 (35.2%) met the definition for persistent GERD. Patients with persistent GERD had decreased HRQoL (36.2 vs. 40.5 PCS, 41.6 vs. 45.7 MCS, and 0.60 vs. 0.66 VR-6D) and greater impairment in work productivity (3.2 vs. 2.1 work hours/week missed due to health) than those without. GERD patients with persistent GERD were more likely to take antacids (50.2%) and H2-receptor antagonists (17.9%) in addition to their PPI than those without (30.9% and 13.4%, respectively). GERD patients with persistent symptoms had more difficulty with sleep than those without. In the preceding week, 38.2% and 14.4%, respectively, reported difficulty falling asleep because of GERD symptoms on > 2 nights, and 29.3% and 10.6%, respectively, woke because of GERD symptoms on > 2 nights.

CONCLUSION:

Among GERD patients taking PPIs, more than one-third had persistent symptoms. Patients with persistent GERD symptoms had decreased HRQoL, greater impairment of work productivity, and greater sleep disturbance than those without.
377 Histologic Response to Steroids in Eosinophilic Esophagitis Is Dependent on Dose and Delivery Compound
Authors: Schupack Daniel A. , Johnson Kimberly , Akambase Joseph A. , Geno Debra , Lavey Crystal , Ravi Karthik , Katzka David A. , Alexander Jeffrey A.
Published: October 2019

INTRODUCTION:

Histologic response rates to steroids for eosinophilic esophagitis (EoE) vary from < 50% to >90% in controlled trials. We have used varied steroid preparations and higher doses than typically used and aimed to study if steroid dose and delivery vehicle might explain the wide variation in response.

METHODS:

A database of patients with EoE created in our esophageal clinic was reviewed and patients treated with at least an 8 week course of topical steroid therapy and undergoing pre and post-steroid histologic evaluation were included. Histologic remission was defined as eosinophil count < 15/hpf. Symptomatic remission was defined as complete resolution of symptoms and eating an unlimited diet. Endoscopy reports were reviewed.

RESULTS:

94 patients were included, 45 on 3 mg budesonide-Rincinol gel twice daily (HBRG), 29 on 3 mg budesonide capsules BID (BC), and 20 on lower doses of BRG (1.5 mg daily to 2 mg BID) (LBRG). 88.5% had dysphagia at time of steroid initiation. Mean eosinophil count before steroids was 58.6/hpf. 38.3% had esophageal dilation just prior to steroids. Average EFERS prior to steroid treatment was 1.8. There were not significant differences between the groups in terms of demographics, initial eosinophil counts, symptoms, visual EoE assessment (EREFS) or dilation rates. Histologic remission rate for HBRG was 82.2% vs 55.1% for all others combined (P < 0.001), 51.7% for BC (P = 0.005 vs 3 mg BRG BID), and 60.0% for LBRG (P = 0.06 vs 3 mg BRG BID). Symptomatic remission was similar between groups, as was change in EREFS and change in eosinophil counts. Non-responders to HBRG had mean decrease in eosinophil count of only 0.3/hpf (vs 53.2/hpf for responders, P < 0.003) and mean change in EREFS of +1.6 (vs −1.1 for responders, P < 0.001). 62.5% of non-responders to HBRG actually had increase in eosinophil count after steroids. Response rate to HBRG at < 5 eos/hpf was 77.8% overall and 94.6% in those achieving remission.

CONCLUSION:

A higher remission rate achieved with a more viscous steroid preparation compared to other formulations suggests the importance of both dose and esophageal delivery in treatment of EoE. Further, with adequate mucosal delivery and dosing of topical steroids, steroid refractory EoE appears to be uncommon. On the other hand, these results suggest the existence of a small truly steroid refractory group of EoE patients with negligible histologic, symptomatic and endoscopic response to high dose steroids that warrant further investigation.
379 Safety and Efficacy of Peroral Endoscopic Myotomy (POEM) in Patients ≥ 65 Years at a Single Academic Tertiary Care Center
Authors: Klair Jagpal S. , Hasan Yazan , Masadeh Maen , Gerke Henning , Murali Arvind , Parekh Kalpaj , Keech John , Nau Peter , El Abiad Rami
Published: October 2019

INTRODUCTION:

Peroral endoscopic myotomy (POEM) has been proven to be effective for treating esophageal dysmotility disorders. Herein is a report of the safety and efficacy of POEM in patients aged ≥65 years at an academic US tertiary care center.

METHODS:

Medical charts of all patients aged ≥65 years that underwent POEM between December 2014 and October 2018 were retrospectively reviewed. Demographic data, clinical data and treatment outcomes were obtained. POEMs were performed by multidisciplinary teams each including 1 of 2 endoscopists (HG, RE) and 1 of 3 surgeons (KP, PN, JK). Clinical success was defined as Eckardt score ≤ 3 and improvement of symptoms.

RESULTS:

During the study period, 62 patients were included. The mean age of patients was 72.3 ± 5.7 years (range 65-89 years; 42% women). Mean BMI was 29.8 kg/m2. Indications for POEM included Achalasia 88.7%, diffuse esophageal spasm (DES) 6.5%, Jackhammer esophagus 3.2% and esophagogastric junction outflow obstruction (EGJOO) 1.6%. There were 2 intraoperative complications documented (pneumothorax and anaphylaxis to medication). Mean pretreatment IRP was 24.1. Pretreatment Eckardt score was 6.98 ± 2.2 compared with posttreatment Eckardt score of 1.25 ± 2 (P < 0.05). Clinical success (Eckardt score ≤3) was achieved in 88.7% of patients. Mean myotomy length 13.8 cm (posterior orientation of myotomy 75.8%). Median hospitalization duration was 1.9 days. Postoperative complications included 1 patient with esophageal leak on postoperative esophagram, 1 patient with esophageal stricture, and 1 patient with both stricture and leak. No deaths occurred. Six patients with persistent symptoms post POEM required through-the-scope dilation to achieve improvement in symptoms.

CONCLUSION:

POEM can be safely carried out in symptomatic elderly patients ≥ with esophageal dysmotility disorders. An excellent clinical response (88.7%) was noted in this patient cohort.
382 Esophageal Mucosal Impedance Measurement During Endoscopy: A New Approach to Diagnosis and Confirmation of Complete Remission of Intestinal Metaplasia Following Radiofrequency Ablation in Barrett’s Esophagus
Authors: Schnoll-Sussman Felice , Katz Philip
Published: October 2019

INTRODUCTION:

Mucosal impedance (MI), measured with a specialized balloon catheter at the time of upper endoscopy reveals a distinct pattern within the esophagus in patients with eosinophilic esophagitis and GERD. This novel technology may also be able to identify a unique profile in Barrett’s esophagus (BE) and confirm Endoscopic Complete Remission of Intestinal Metaplasia (ECRIM) following Radiofrequency energy ablation (RFA).

AIM:

Explore utility of MI in identification of BE and confirmation of ECRIM following RFA.

METHODS:

Patients (pts) with endoscopic and biopsy proven BE, most dysplasia undergoing RFA were prospectively enrolled. All were maintained on BID PPI. EGD noted top of gastric folds, SCJ, Prague criteria, hernia size and presence of nodules. Pts with nodular disease were excluded. RFA was performed per standard protocol and repeated until ECRIM achieved. Measurements were obtained with an MI balloon (Diversatek Healthcare, CO) 10 cm x 5 mm with two axial arrays of 10 sensors, throughout the entire BE segment and 5 cm above at pre-ablation EGD and following achieving ECRIM. At ECRIM endoscopic surveillance biopsies (q 1 cm; 4 quadrant) and WATS brushings were obtained to confirm CRIM.

RESULTS:

16 pts 11M/5F, ages 26-71 years, all Caucasian were enrolled. BE length from 1-15 cm. (adenoca 1, LGD 5, HGD 5, indefinite1, Non dysplastic 4. To date, 7 pts have been studied prior to the initial RFA ablation and at ECRIM. 2 pts were studied only at end of RFA with ECRIM. 7 are in active treatment. MI measured within the BE segment ranged from 350-980 ohms pre RFA. (Normal >2500, EoE, GERD >1000). Post RFA MI measurements ranged from 1800- >5000 ohms. 5/7 pts that achieved ECRIM had normalization of the MI pattern visualized (all values >2500). The 2 pts that did not achieve normalization of the MI pattern demonstrated MI values consistent with inflammation in squamous tissue but no values suggestive of BE. Pathology confirmed absence of IM in all 9 pts.

CONCLUSION/SUMMARY:

1) BE exhibits MI consistently < 500 ohms and always below 1000 ohms, a unique MI profile not evident in GERD or EoE. 2) In pts who achieved ECRIM and biopsy and WATS proven CRIM following RFA ablation, the neosquamous esophageal mucosa exhibits a MI pattern similar to normal native squamous epithelium. Balloon catheter MI measurements can reliably identify BE epithelium and may be a valuable tool in assessment of post-RFA reversion to neosquamous epithielium and therefore successful BE ablation.
384 High Accuracy and Effectiveness With Deep Neural Networks and Artificial Intelligence in Detection of Early Esophageal Neoplasia in Barrett's Esophagus
Authors: Hashimoto Rintaro , El Hage Chehade Nabil , Chang Kenneth J. , Dao Tyler , Ninh Andrew , Requa James , Karnes William , Samarasena Jason
Published: October 2019

INTRODUCTION:

The visual detection of early esophageal neoplasia (high grade dysplasia and T1 cancer) in BE with white light and virtual chromoendoscopy is still difficult. The aim of this study is to assess if a convolutional neural artificial intelligence network can aid in the recognition of early esophageal neoplasia in BE.

METHODS:

Over 800 images from 65 patients were retrospectively collected of histology-proven early esophageal neoplasia in BE containing high grade dysplasia or T1 cancer (Dysplasia Group). Within each image, the area of neoplasia was masked using image annotation software by two experts in BE imaging. Over 800 control images were collected of either histology-proven or confocal endomicroscopy-proven BE without high grade dysplasia (Non -Dysplastic Group). A training set with ∼1200 images split 50/50 Dysplasia/Non-Dysplasia was used to train the algorithm. We used a convolutional neural network (CNN) and hybrid algorithm design including Inception blocks to deepen the neural net and maximize efficiency and accuracy. The algorithm was pre-trained on ImageNet and then fine-tuned with the goal to provide the correct binary classification: “Dysplastic” (1) or “Non-dysplastic” (0). Adam optimizer performed stochastic optimization of a binary cross-entropy loss function to produce a probability value between 0 and 1. A set 458 images unique of the training set was used for algorithm validation. We additionally developed an object detection algorithm which drew localization boxes in real-time around regions classified as dysplasia. Testing was performed for near-focus images, non-near focus (far) images, white light and NBI images.

RESULTS:

The CNN analyzed 458 test images (225 dysplasia/233 non-dysplasia) and correctly detected early neoplasia in BE cases with sensitivity of 95.6% and specificity of 91.8%. The accuracy was 93.7% and the AUC was 0.94 (Figure 3). With regards to the object detection algorithm for all images in the validation set, the system was able to achieve a mean-average-precision (mAP) of 0.7533 at an intersection over union (IOU) of 0.3, Sensitivity 96.7% and Specificity 87.6% (Figure 1).

CONCLUSION:

Our AI model was able to detect early esophageal neoplasia in Barrett’s Esophagus images with 93.7% accuracy. In addition, the object detection algorithm was able to draw a localization box around the areas of dysplasia with high precision.
388 Endoscopic Intrapyloric Botulinum Toxin Injection With Pyloric Balloon Dilation for Delayed Gastric Emptying After Distal Esophagectomy for Esophageal Cancer: A 10-Year Experience
Authors: Bhutani Manoop S. , Ejaz Shamim , Cazacu Irina M. , Singh Ben S. , Shafi Mehnaz A. , Stroehlein John , Mehran Reza , Walsh Garrett , Vaporciyan Ara A. , Swisher Stephen , Hofstetter Wayne
Published: October 2019

INTRODUCTION:

As patients with esophageal cancer undergoing esophagectomy have an improved survival over time, complications associated with the use of a gastric conduit are increasingly being reported. Delayed gastric emptying (DGE) is an esophagectomy-related adverse event which may cause debilitating symptoms, malnutrition and decreased quality of life. The aim of our study was to evaluate the effect of endoscopic intrapyloric BT injection combined associated with pyloric balloon dilation in patients with DGE after distal esophagectomy treated at a tertiary cancer center.

METHODS:

Patients with a prior history of esophageal cancer and distal esophagectomy who had undergone endoscopic BT injection with pyloric balloon dilation by a single endoscopist between 2007 and 2017 were included in the study.100 units of BT were injected endoscopically into the pylorus in four quadrants using a standard needle. Following BT injection, a standard through-the-scope balloon was passed to the pylorus and inflated to a maximum diameter of 12-20 mm. For patients who underwent repeat procedures, the symptomatic outcomes were assessed and documented by the endoscopist; for the other patients, the electronic medical records were reviewed.

RESULTS:

A total of 21 patients undergoing 44 endoscopic intrapyloric botox injections combined with balloon dilatations were identified. Baseline characteristics are summarized in Table 1. The patients underwent the procedures at a median of 22 months (range, 1-108 months) after esophagectomy. The procedures were performed only once in 43% of the patients; 43% patients underwent the procedure twice, while 14% had it multiple times.Overall, intrapyloric BT injection coupled with balloon dilation was a safe procedure, without any major immediate or delayed (1 month) procedure-related adverse events. 18 patients (85%) reported a significant overall improvement in symptoms from the initial presentation. One patient (5%) had shown no improvement, whereas in two (10%) patients responses were not available.

CONCLUSION:

In our particular cohort of patients, the interventions of endoscopic intrapyloric BT injection with pyloric balloon dilation proved to be very beneficial, leading to significant symptomatic improvement. The balloon dilation after BT injection might have resulted in better diffusion of the BT into the pyloric sphincter complex and possibly increasing its therapeutic effects. Further prospective studies are needed to validate these results.
393 7 Patterns of Esophageal Motility Disorders Detected by Multiple Rapid Swallows
Authors: Tran Victoria , Averbukh Leon D. , Tadros Micheal
Published: October 2019

INTRODUCTION:

High resolution manometry (HRM) has improved the ability to detect esophageal motility abnormalities. In conjunction with HRM, the Chicago Classification has been widely used to classify these disorders. Provocative tests, such as multiple rapid swallows, are used as a preoperative assessment for GERD and hiatal hernia. Our study assesses the utility of MRS beyond its use as a preoperative assessment.

METHODS:

After completion of the standard protocol, patients perform multiple rapid swallows under the instruction and supervision of a trained RN. MRS consists of a series of rapid 2-mL swallows at 2-3 second intervals. Patient repeats MRS with the goal of 3-4 MRS.

RESULTS:

In this cohort, we had a total of 90 patient: 3 patients were excluded from MRS due to high suspicion of achalasia. 5 patients did not complete MRS protocol. 2 cases only tolerated 1 MRS. MRS aided in the diagnosis of 16 patients, with a diagnostic utility of 20%. We identified the following 7 patterns: 1) loss of peristaltic reserve, 2) presence of good reserve, 3) repetitive spasm pattern, 4) unmasking hypercontractility, 5) paradoxical LES contractions, 6) loss of deglutition inhibition, 7) distal esophageal pressurization.

CONCLUSION:

Currently, HRM studies involve a series of single swallows, which do not represent normal swallowing physiology. In contrast, MRS comprises series of wet swallows, which may better represent deglutition pathophysiology as it inhibits esophageal smooth muscles contraction and relaxes the lower esophageal sphincter (LES). Thus, MRS is hypothesized to serve as a non-invasive substitute to evaluate esophagus integrity. In our study, MRS had a high diagnostic yield in assessing peristaltic reserve, unmasking underlying hypercontractility and esophageal spasm, and confirming true outflow obstruction with pressurization pattern. Pathophysiology was also detected such as paradoxical LES contraction and loss of deglutition inhibition, which helped with diagnosing cases of achalasia variant and esophageal spasm. MRS is an effective, simple, and inexpensive technique to identify esophageal disorders. It was very well tolerated by majority of patients and did not add cost to the procedure. We recommend standardizing MRS in HRM protocol as it provides a better understanding of esophageal disorders. Stoikes, Nathaniel et al. “The value of multiple rapid swallows during preoperative esophageal manometry before laparoscopic antireflux surgery.” 2012: 3401-7.
398 Identification of Varicella Zoster by Novel Salivary and Esophageal Muscle Tissue Assay in Patients With Achalasia: A Two Center Prospective Study
Authors: Naik Rishi , Gershon Anne , Higginbotham Tina , Gershon Michael , Chen Jason , Flores Elizabeth , Holzman Mike , Vaezi Michael
Published: October 2019

INTRODUCTION:

Achalasia is an esophageal motor disorder characterized by impaired relaxation of the lower esophageal sphincter (LES) but the etiology of this neuronal damage is unknown. Varicella zoster virus (VZV) is an exclusively human neurotrophic alpha herpes virus that becomes latent in ganglionic neurons after initial infection. We tested the hypothesis that reactivation of latent VZV within esophageal enteric neurons initiates an inflammatory cascade that damages the innervation of the smooth muscle of the LES giving rise to achalasia. We aimed to determine whether VZV DNA, transcripts, and proteins are present in tissue and saliva of patients with achalasia and controls.

METHODS:

Fifteen patients with achalasia (60% Male, average age 60 years and BMI 28 kg/m2) diagnosed with high resolution manometry (7/15 with Type II Achalasia) who underwent surgical myotomy had prospective collection of saliva and LES muscle tissue with IRB approval. Salivary samples were collected by passive drool, DNA was extracted with the DNeasy Blood and Tissue Kit, and VZV DNA was amplified with PCR. All methods examined the presence of transcripts (cDNA) and DNA encoding VZV open reading frames (ORFs) 29, 40, and 67. Immunofluorescence (IMF) was used to demonstrate the neuronal markers, beta-3 tubulin or peripherin simultaneously with the VZV late protein, gE. Antigen retrieval at 100°C in citrate buffer (pH 6.0) was employed.

RESULTS:

VZV DNA was detected in the saliva in 12/15 (80%) of achalasia cases (Table 1). Transcripts encoding at least one ORF were found in esophageal myotomy samples 12/15 (80%), while DNA was detected in 7/15 (47%). All 15 patients had active VZV infection by salivary VZV DNA and/or VZV transcription in esophageal tissue (Figure 1). Detection of transcripts was more sensitive and specific indicator of tissue infection than DNA. IMF revealed the presence of gE within the cell bodies of enteric neurons (when present) (Figure 2). VZV DNA was not detected in the saliva of 20 controls.

CONCLUSION:

Direct ex-vivo examination of saliva and tissue from patients with achalasia revealed the presence of active VZV infection of the esophagus. Transcripts encoding VZV gene products, and DNA, support actively replicating virus, not just latent VZV. Immunocytochemistry suggested that enteric neurons were the site of VZV infection. These findings support VZV is a potential esophageal pathogen that reactivates from latency in enteric neurons to give rise to achalasia, which may be a therapeutic target.
404 Functional Outcomes of Gastric Conduit Post-Esophagectomy
Authors: Lewis Justin , Yip Benjamin , Siemens Kyla , Borzy Charlie , Diamond Sarah , Dolan James , Otaki Fouad
Published: October 2019

INTRODUCTION:

Esophagectomy and gastric conduit formation is the standard of care for most esophageal cancers. Studies have evaluated different surgical techniques to reduce complications of delayed gastric emptying (DGE), reflux, and dumping syndrome, but few studies have assessed the functional outcomes of dysphagia, nausea, or vomiting post-esophagectomy. Our study evaluated the rate of functional conduit malfunction in patients who underwent an esophagectomy, and the response to medical, endoscopic, and surgical treatments. We hope this data will ultimately help standardize pre- and post-surgical management for such patients.

METHODS:

We performed a single-center retrospective review of patients with esophageal cancer treated with esophagectomy and gastric conduit formation from 2016 - 2018. Patients with prior esophagogastric surgery, underlying dysmotility disorders, and recurrence of disease were excluded. Data was case matched with asymptomatic patients post-esophagectomy. Our primary endpoint was the development of conduit malfunction symptoms (defined as patients who underwent upper endoscopy or esophagram for symptoms, as well as patients who received medical treatment for dysphagia, nausea, vomiting, and DGE). Secondary endpoints included medical, endoscopic, and surgical treatments for esophageal symptoms.

RESULTS:

50/75 patients who underwent esophagectomy in the 2-year study period were symptomatic. Symptomatic patients had greater BMI, but had comparable demographics, tumor biology, treatment, and histological features (Table 1). Initial treatment for the majority of patients was adjustment of prokinetics; some received endoscopy and few underwent revision surgery (Figure 1). Partial and complete response to medical therapy was 64% and 14%, respectively. The most common endoscopic intervention was pyloric balloon dilation, followed by stent placement; 62.5% had partial response, and only 8% full response. Only 1 out of 4 patients who underwent revision surgery had complete resolution of symptoms. There were no significant predictors of symptoms on univariate analysis.

CONCLUSION:

The majority of patients who underwent esophagectomy with gastric conduit formation for esophageal cancer developed nausea, vomiting, dysphagia, or DGE. A minority of patients had complete response to endoscopic or surgical treatment for these symptoms. Future studies should identify predictors of symptoms to help risk stratify patients with high morbidity post-esophagectomy.
406 Lymphocytic and Eosinophilic Esophagitis: A Comparative Study
Authors: Avila Meera , Khurana Shruti , Ambelil Manju , Tong Yi , Abraham Fiyinfoluwa , Ertan Atilla , Thosani Nirav , DuPont Andrew , Cash Brooks D. , Younes Mamoun
Published: October 2019

INTRODUCTION:

While the histopathologic criteria for the diagnosis of eosinophilic esophagitis (EoE) and the related clinical and endoscopic manifestations are well established, little is known about lymphocytic esophagitis (LyE). The aim of this study was to determine whether significant correlations exist between the numbers of intraepithelial lymphocytes (IEL) in esophageal biopsies and clinical and endoscopic manifestations usually associated with EoE.

METHODS:

H&E slides from esophageal biopsies from 331 conscutive patients were reviewed. The number of IEL and intraepithelial eosinophils (IEE) per mm2 was counted in the area with highest concentration in each biopsy. The numbers were then correlated with clinical and endoscopic findings.

RESULTS:

As expected, the mean number of IEE was significantly higher in patients with complaints of food impaction (149 vs 38, P < 0.001) and dysphagia (91 vs 38, P = 0.002) and with rings (161 vs 39, P < 0.001), furrows (207 vs 48, P < 0.001) or strictures (136 vs 51, P = 0.008) typical with EoE seen on endoscopy compared to those without these complaints or findings. By contrast, there were no significant increase in mean IEL in patients complaining of food impaction (136 vs 153, P = 0.554) or dysphagia (152 vs 154, P = 0.902) or with rings (131 vs 154, P = 0.357), furrows (130 vs 152, P = 0.569) or strictures (118 vs 153, P = 0.0332) seen on endoscopy. Mean IEL was higher in smokers (180 vs 139, P = 0.029) and high IEL showed positive correlation with rings on endoscopy (P = 0.013, Spearman’s Rank), history of alcohol use (P = 0.015) and almost correlated with food impaction (P = 0.059). Interestingly, there was weak but significant negative correlation between IEL and IEE (r = -0.299, P < 0.001).

CONCLUSION:

In contrast to IEE in EoE, our study failed to show significant correlation between IEL and major clinical and endoscopic findings usually associated with EoE.