The Upper Esophageal Sphincter Assist Device Is Associated With Symptom Response in Reflux-Associated Laryngeal Symptoms.

Reflux-associated laryngeal symptoms (RALS) is the process in which chronic laryngeal symptoms are related to gastroesophagopharyngeal reflux.1 Impairment of upper esophageal sphincter (UES) reflexes may predispose to esophagopharyngeal reflux.1 The novel noninvasive nonpharmacologic UES assist device (UESAD) applies external cricoid pressure to augment intraluminal UES pressure by 20 to 30 mm Hg and reduce esophagopharyngeal reflux events.2 This study aimed to assess the therapeutic efficacy of the UESAD in a pragmatic clinical setting, and to identify factors associated with symptom response among patients with suspected RALS.

Management options for patients with GERD and persistent symptoms on proton pump inhibitors: recommendations from an expert panel.

BACKGROUND: The aim of this study was to assess expert gastroenterologists' opinion on treatment for distinct gastroesophageal reflux disease (GERD) profiles characterized by proton pump inhibitor (PPI) unresponsive symptoms. METHODS: Fourteen esophagologists applied the RAND/UCLA Appropriateness Method to hypothetical scenarios with previously demonstrated GERD (positive pH-metry or endoscopy) and persistent symptoms despite double-dose PPI therapy undergoing pH-impedance monitoring on therapy. A priori thresholds included: esophageal acid exposure (EAE) time >6.0%; symptom-reflux association: symptom index >50% and symptom association probability >95%; >80 reflux events; large hiatal hernia: >3 cm. Primary outcomes were appropriateness of four invasive procedures (laparoscopic fundoplication, magnetic sphincter augmentation, transoral incisionless fundoplication, radiofrequency energy delivery) and preference for pharmacologic/behavioral therapy. RESULTS: Laparoscopic fundoplication was deemed appropriate for elevated EAE, and moderately appropriate for positive symptom-reflux association for regurgitation and a large hiatal hernia with normal EAE. Magnetic sphincter augmentation was deemed moderately appropriate for elevated EAE without a large hiatal hernia. Transoral incisionless fundoplication and radiofrequency energy delivery were not judged appropriate in any scenario. Preference for non-invasive options was as follows: H2RA for elevated EAE, transient lower esophageal sphincter relaxation inhibitors for elevated reflux episodes, and neuromodulation/behavioral therapy for positive symptom-reflux association. CONCLUSION: For treatment of PPI unresponsive symptoms in proven GERD, expert esophagologists recommend invasive therapy only in the presence of abnormal reflux burden, with or without hiatal hernia, or regurgitation with positive symptom-reflux association and a large hiatus hernia. Non-invasive pharmacologic or behavioral therapies are preferred for all other scenarios.

The Reflux Improvement and Monitoring (TRIM) Program Is Associated With Symptom Improvement and Weight Reduction for Patients With Obesity and Gastroesophageal Reflux Disease.

OBJECTIVES: Current healthcare systems do not effectively promote weight reduction in patients with obesity and gastroesophageal reflux disease (GERD). The Reflux Improvement and Monitoring (TRIM) program provides personalized, multidisciplinary, health education and monitoring over 6 months. In this study we aimed to (i) measure the effectiveness of TRIM on GERD symptoms, quality of life, and weight, and (ii) examine patient health beliefs related to TRIM. METHODS: This prospective mixed methods feasibility study was performed at a single center between September 2015 and February 2017, and included adult patients with GERD and a body mass index ≥30 kg/m2. Quantitative analysis consisted of a pre- to post-intervention analysis of TRIM participants (+TRIM Cohort) and a multivariable longitudinal mixed model analysis of +TRIM vs. patients who declined TRIM (-TRIM Cohort). Primary outcomes were change in patient-reported GERD symptom severity (GerdQ) and quality of life (GerdQ-DI), and change in percent excess body weight (%EBW). Qualitative analysis was based on two focus groups of TRIM participants. RESULTS: Among the +TRIM cohort (n=52), mean baseline GerdQ scores (8.7±2.9) decreased at 3 months (7.5±2.2; P<0.01) and 6 months (7.4±1.9; P=0.02). Mean GerdQ-DI scores decreased, but did not reach statistical significance. Compared with the -TRIM cohort (n=89), reduction in %EBW was significantly greater at 3, 6, and 12 months among the +TRIM cohort (n=52). In qualitative analysis, patients unanimously appreciated the multidisciplinary approach and utilized weight loss effectively to improve GERD symptoms. CONCLUSIONS: In this mixed methods feasibility study, participation in TRIM was associated with symptom improvement, weight reduction, and patient engagement.

Real-Time Characterization of Diminutive Colorectal Polyp Histology Using Narrow-Band Imaging: Implications for the Resect and Discard Strategy.

BACKGROUND & AIMS: Narrow-band imaging (NBI) allows real-time histologic classification of colorectal polyps. We investigated whether endoscopists without prior training in NBI can achieve the following thresholds recommended by the American Society for Gastrointestinal Endoscopy: for diminutive colorectal polyps characterized with high confidence, a ≥90% negative predictive value for adenomas in the rectosigmoid and a ≥90% agreement in surveillance intervals. METHODS: Twenty-six endoscopists from 2 tertiary care centers underwent standardized training in NBI interpretation. Endoscopists made real-time predictions of diminutive colorectal polyp histology and surveillance interval predictions based on NBI. Their performance was evaluated by comparing predicted with actual findings from histologic analysis. Multilevel logistic regression was used to assess predictors of performance. Cumulative summation analysis was used to characterize learning curves. RESULTS: The endoscopists performed 1451 colonoscopies and made 3012 diminutive polyp predictions (74.3% high confidence) using NBI. They made 898 immediate post-procedure surveillance interval predictions. An additional 505 surveillance intervals were determined with histology input. The overall negative predictive value for high-confidence characterizations in the rectosigmoid was 94.7% (95% confidence interval: 92.6%-96.8%) and the surveillance interval agreement was 91.2% (95% confidence interval: 89.7%-92.7%). Overall, 97.0% of surveillance interval predictions would have brought patients back on time or early. High-confidence characterization was the strongest predictor of accuracy (odds ratio = 3.42; 95% confidence interval: 2.72-4.29; P < .001). Performance improved over time, however, according to cumulative summation analysis, only 7 participants (26.9%) identified adenomas with sufficient sensitivity such that further auditing is not required. CONCLUSIONS: With standardized training, gastroenterologists without prior expertise in NBI were able to meet the negative predictive value and surveillance interval thresholds set forth by the American Society for Gastrointestinal Endoscopy. The majority of disagreement in surveillance interval brought patients back early. Performance improves with time, but most endoscopists will require ongoing auditing of performance. ClinicalTrials.gov ID NCT02441998.

High-Resolution Impedance Manometry Metrics of the Esophagogastric Junction for the Assessment of Treatment Response in Achalasia.

OBJECTIVES: We aimed to evaluate the value of novel high-resolution impedance manometry (HRIM) metrics, bolus flow time (BFT), and esophagogastric junction (EGJ) contractile integral (CI), as well as EGJ pressure (EGJP) and the integrated relaxation pressure (IRP), as indicators of treatment response in achalasia. METHODS: We prospectively evaluated 75 patients (ages 19-81, 32 female) with achalasia during follow-up after pneumatic dilation or myotomy with Eckardt score (ES), timed-barium esophagram (TBE), and HRIM. Receiver-operating characteristic (ROC) curves for good symptomatic outcome (ES≤3) and good radiographic outcome (TBE column height at 5 min<5 cm) were generated for each potential predictor of treatment response (EGJP, IRP, BFT, and EGJ-CI). RESULTS: Follow-up occurred at a median (range) 12 (3-291) months following treatment. A total of 49 patients had good symptomatic outcome and 46 had good radiographic outcome. The area-under-the-curves (AUCs) on the ROC curve for symptomatic outcome were 0.55 (EGJP), 0.62 (IRP), 0.77 (BFT) and 0.56 (EGJ-CI). The AUCs for radiographic outcome were 0.64 (EGJP), 0.48 (IRP), 0.73 (BFT), and 0.65 (EGJ-CI). Optimal cut-points were determined as 11 mm Hg (EGJP), 12 mm Hg (IRP), 0 s (BFT), and 30 mm Hg•cm (EGJ-CI) that provided sensitivities/specificities of 57%/46% (EGJP), 65%/58% (IRP), 78%/77% (BFT), and 53%/62% (EGJ-CI) to predict symptomatic outcome and 57%/66% (EGJP), 57%/41% (IRP), 76%/69% (BFT), and 57%/66% (EGJ-CI) to predict radiographic outcome. CONCLUSIONS: BFT, a novel HRIM metric, provided an improved functional assessment over manometric measures of EGJP, IRP, and EGJ-CI at follow-up after achalasia treatment and may help direct clinical management.

The dysphagia stress test for rapid assessment of swallowing difficulties in esophageal conditions.

BACKGROUND: Esophageal dysphagia is a common symptom in gastroenterology practice. Current rapid assessment tools are limited to oropharyngeal dysphagia and do not translate well to esophageal conditions. We aim to create a novel tool, the dysphagia stress test (DST), to evaluate swallowing in patients with esophageal disease characterized by dysphagia. METHODS: Adults with eosinophilic esophagitis (EoE), gastroesophageal reflux disease (GERD), achalasia, and dysphagia not otherwise specified (NOS) participated. Patient controls with non-esophageal diagnoses and healthy controls were also recruited. Participants completed the DST with five bolus challenges: water, applesauce, rice, bread, barium tablet and rated their swallowing difficulty and pain. A study clinician observed and documented water use and refusal of any challenges. Participants also completed measures of esophageal symptoms, hypersensitivity, and symptom anxiety to evaluate the DST validity. Collinearity of bolus challenges guided item reduction. KEY RESULTS: A total of 132 subjects participated. Both control groups and GERD patients had the best swallowing ability, while achalasia, EOE, and dysphagia NOS scored poorer. About 90% of patients were able to attempt or pass each of the bolus challenges, suggesting high acceptability. Construct validity of the DST is evidenced by modest negative correlations with symptom severity, hypersensitivity, and anxiety. The DST does not appear to be influenced by brain-gut processes. Applesauce, rice, and bread demonstrated collinearity; thus, the DST was reduced to three challenges. CONCLUSIONS & INFERENCES: The DST is the first rapid assessment tool designed for gastroenterology clinics with direct observation of swallowing ability across several conditions to mitigate issues related to patient self-report of esophageal symptoms.