Refractory Gastroesophageal Reflux Disease Research Articles

Clinical management and outcome assessment of generalized anxiety disorder or panic disorder in refractory gastro-esophageal reflux disease: Evidence from a prospective interventional study of benzodiazepines and sertraline

ObjectiveThe aim of the study was to investigate the relationship between Gastro-esophageal reflux diseases (GERD) related symptoms and psychological symptomatology, as well as clinically diagnosed generalized anxiety disorder (GAD) or panic disorder (PD) and effectiveness of Sertraline and benzodiazepines in controlling these conditions. MethodologyA 6 months prospective study was conducted in gastroenterology outpatient department of a tertiary care referral hospital. Refractory GERD was diagnosed by assessing proton pump inhibitor failure over 4 week trial of standard doses of PPIs. Therapy with Benzodiazepines and Sertraline was initiated in patients with refractory GERD having panic and anxiety symptoms associated with refractory GERD. Effectiveness of the therapy was measured using panic and agoraphobia scale and Hamilton anxiety scale. Reduction in the severity of GERD symptoms was assessed using GERD – Health related quality of life scale. ResultsThe occurrence of PD or GAD in patients with refractory GERD in our sample was found to be 68% and 32% respectively. There was a significant decrease in the score of GERD HRQOL after the administration of sertraline and benzodiazepines when compared to the score of GERD HRQOL before administration of interventional drugs (p = 0.001). ConclusionOur study investigated the role of anxiety and panic in refractory GERD and their effect on quality of life. The results indicated that quality of life of patients were highly improved as indicated by severity scores after administration with sertraline and benzodiazepines. The novel therapy of sertraline and benzodiazepines are highly effective in controlling reflux like symptoms and coexisting anxiety and panic disorder in refractory GERD.

IW-3718 Reduces Heartburn Severity in Patients With Refractory Gastroesophageal Reflux Disease in a Randomized Trial

Refractory gastroesophageal reflux disease (GERD) reduces quality of life and creates significant financial burden on the health care system. Approximately 30% of patients with GERD who receive label-dose proton pump inhibitors (PPIs) still have symptoms. We performed a trial to evaluate the efficacy and safety of IW-3718, a bile acid sequestrant, as an adjunct to PPI therapy. We performed a multicenter, double-blind, placebo-controlled trial, from March 2016 through April 2017, of 280 patients with confirmed GERD. The patients, stratified by esophagitis status, were randomly assigned (1:1:1:1) to groups given placebo or IW-3718 (500, 1000, or 1500 mg) twice daily, with ongoing label-dose PPI. The primary endpoint was percent change from baseline to week 8 in weekly heartburn severity score. We also analyzed percent change from baseline to week 8 in weekly regurgitation frequency score. Mean changes from baseline to week 8 in weekly heartburn severity scores were reductions of 46.0% in the placebo group, 49.0% in the 500 mg group, 55.1% in the 1000 mg group, and 58.0% in the 1500 mg IW-3718 group (dose-response P= .02). The treatment difference was 11.9% between the 1500 mg IW-3718 and placebo groups (P= .04, analysis of covariance). The mean change in weekly regurgitation frequency score from baseline to week 8 in the 1500 mg IW-3718 vs placebo groups was a reduction of 17.5% (95% confidence interval, reductions of 31.4% to 3.6%). The most common adverse event was constipation (in 8.1% of patients receiving IW-3718 and 7.1% of patients receiving placebo). There were no drug-related serious adverse events. In a randomized trial of patients with refractory GERD, adding 1500 mg IW-3718 to label-dose PPIs significantly reduced heartburn symptoms compared with adding placebo. Regurgitation symptoms also decreased. IW-3718 was well tolerated. (ClinicalTrials.gov, Number: NCT02637557).

Laparoscopic fundoplication for refractory GERD: a procedure worth repeating if needed.

Laparoscopic fundoplication is the current gold standard for medically refractory gastroesophageal reflux disease. Over a 10-year period following surgery, 5-10% of primary laparoscopic fundoplication patients undergo reoperative surgery. Our objective was to compare the symptomatic outcomes and morbidity of primary and reoperative fundoplication procedures. This was a retrospective review of patients who underwent laparoscopic primary or reoperative fundoplication between 2011 and 2017. A single surgeon with a more than 10-year experience in reoperative foregut surgery performed all procedures. Patients in both groups completed the GERD health-related quality of life (GERD-HRQL) survey prior to surgery and postoperatively. Outcomes were reflected by the composite GERD-HRQL scores (0 to 50, with lower scores representing a better GERD-related quality of life), which were compared between groups postoperatively. Demographics, perioperative data, and complications were compared. Patient data were analyzed using Chi-Square tests and outcomes were analyzed using independent samples t tests and Mann-Whitney U tests. There were 136 primary and 82 reoperative fundoplications. Prior to surgery, GERD-HRQL scores were similar for primary and reoperative patients. Both groups experienced significant improvement in GERD-related quality of life at 2years, although this improvement was greater in primary patients (8.7 ± 7.8 primary vs. 14.3 ± 13.6 reoperative, p = 0.02). Operative time and length of stay were longer following reoperative cases. The rate of moderate to severe 30-day complications requiring radiologic, endoscopic, or surgical intervention was similar (2.9% primary vs. 1.2% reoperative, p = 0.65). Patients who undergo reoperative fundoplication experience a significant improvement in their GERD-related symptoms, although not to the degree seen in primary antireflux surgery patients. Perioperative morbidity rates following reoperative and primary procedures can be similar in the hands of an experienced surgeon.

Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study.

Background The incidence of proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) has been increasing. While surgical intervention with Laparoscopic Nissen Fundoplication remains the gold standard, less invasive anti-reflux interventions are desired. We have developed a minimally invasive anti-reflux mucosal ablation (ARMA) treatment. Herein, we report its technical details and describe its feasibility, safety, and efficacy in PPI-refractory GERD. Methods We conducted a prospective single-center single-arm interventional trial evaluating the outcome of ARMA in 12 patients with PPI-refractory GERD. GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) evaluation, Frequency Scale for the Symptoms of GERD (FSSG) assessment, and impedance-pH monitoring were performed at baseline and at 2 months post-ARMA. Results A total of 12 patients underwent ARMA with a median follow-up duration of 9 months (range: 6 – 14 months). Median GERD-HRQL score significantly improved from 30.5 to 12 ( P = 0.002); median FSSG score significantly improved from 25 to 10.5 ( P = 0.002), and median DeMeester score decreased from 33.5 to 2.8 ( P = 0.049) at 2 months follow-up. No immediate complications were observed. Conclusion Our pilot study has shown that ARMA, a new endoscopic treatment for PPI-refractory GERD, is simple, safe, and improves GERD-related symptoms and objective acid reflux parameters.

Antireflux mucosectomy band in treatment of refractory gastroesophageal reflux disease: a pilot study for safety, feasibility and symptom control.

Background and study aims Antireflux mucosectomy band ligation (ARM-b) is an endoscopic procedure that mimics a fundoplication for managing gastroesophoageal reflux disease (GERD). The aim of this study was to assess safety and feasibility of ARM-b. Patients and methods This was a single-center study on consecutive patients operated between June 2017 and January 2019 with refractory GERD, confirmed with pH-metry and without motility disorder at high-resolution manometry. A piecemeal mucosectomy of three quarters of circumference of esophagogastric junction was performed using a band ligation system and a hexagonal snare. The primary objective was to assess procedural safety and feasibility. The secondary objective was to document the clinical improvement at 3 and 6 months based on patient satisfaction, proton pump inhibitor (PPI) intake, symptoms, and quality of life scores. Results Twenty-onepatients (11 men) with mean age 56.9 ± 14.4 years were analyzed. The technical success rate was 100 % (mean duration 35 ± 11 min). Four patients (19 %) had mild adverse events: one delayed bleeding at Day 1 managed conservatively, and three dysphagia endoscopically managed. Mean follow-up was 10 ± 5 months. Decrease/discontinuation of PPI intake was 76 % at 3 months and 72 % at 6 months. Improvement in mean symptoms and quality of life scores (GERD-Q and GERD-HQL) were statistically significant. One patient required laparoscopic fundoplication after ARM-b failure without complication. Conclusion ARM-b is safe, feasible, and symptom-effective for treating refractory GERD, and it can be performed in the ambulatory setting. Further prospective studies are required to confirm these promising outcomes.

Evaluation of serum levels of Interleukin-4 in Egyptian patients with refractory gastroesophageal reflux disease

ABSTRACT Introduction: Gastroesophageal reflux disease is defined as bothersome symptoms and/or complications caused by the reflux of stomach contents. About 40–50% of patients develop refractory gastroesophageal reflux disease (R-GERD), with poor improvement of symptoms with treatment. Many pathogenic mechanisms share in development of R-GERD, among which is the important role of T-helper 1 and T-helper 2 response mediated by cytokines. The interleukin-4 is a cytokine known of its anti-inflammatory effect. In this study, we aimed to evaluate the level of interleukin-4 in Egyptian patients with R-GERD versus those with GERD. PATIENTS AND Methods: Our study included 25 patients with reflux symptoms who received PPIs for less than 8 weeks with improvement of symptoms, versus 25 patients with refractory reflux symptoms who received PPIs for more than 8 weeks without improvement of symptoms. Interleukin-4 levels were assessed in both groups by ELISA. Results: There was a statistically significant difference between the two groups as regard interleukin-4 levels (p < 0.012) which was higher in the patients with (R-GERD), the mean level of IL-4 was 37.31 ± 56.07 in GERD group while in R-GERD group, it was 102.78 ± 112.29. The diagnostic accuracy of interleukin-4 revealed a sensitivity of 56% and specificity of 76% at cutoff value >58.25 pg/ml, with an acceptable accuracy of 0.6. Conclusions: The present study concluded that IL-4 is significantly higher in patients with R GERD with cut off value > 58.25 pg/ml. Therapeutic strategies that modulate the production of IL-4 may provide a good solution for treatment of R GERD.

A preliminary report on the use of Midodrine in treating refractory gastroesophageal disease: Randomized Double-Blind Controlled Trial.

Background:Gastroesophageal reflux disease (GERD) is a common disease with various clinical presentations. Acid suppression with proton pump inhibitors and lifestyle modification may not lead to satisfactory response in a substantial portion of patients. We investigated the possible effect of midodrine in patients with refractory GERD.Methods:Patients suffering from GERD and were refractory to one-month course of pantoprazole 40mg twice daily entered the study. This was a pilot, randomized, double-blind, and placebo-controlled study. After randomization, one group received Midodrine 5mg before meals for one month, and the other group received placebo for the same period. Meanwhile, pantoprazole was continued 40mg twice daily in both arms. The severity of symptoms was evaluated by the visual scoring system. Quality of life (QoL) in both groups was measured using a standardized version of Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD).Results:A total of twenty patients were enrolled in this study. There was a significant interaction between the groups and time on all measured scores based on QOLRAD questionnaire. All the markers in the Midodrine group had significant improvement over time, but the placebo group did not show any significant improvement. Both visual severity score and total QoL score in Midodrine arm showed a U shape change during 6 weeks.Conclusions:Midodrine before a meal could be useful in alleviating symptoms and improving QoL in the patients with refractory gastroesophageal disease. (www.actabiomedica.it)

In Pursuit of the Parietal Cell - An Evolution of Scientific Methodology and Techniques.

The stomach has unique embryologic and anatomic properties, making the study of the parietal cell technically challenging. Numerous individuals have devoted decades of research to unraveling the pathophysiological basis of this cell type. Here, we perform a scoping review of novel in vitro and in vivo methodology pertaining to the parietal cell. First, we evaluate early in vitro methods of parietal cell analysis. This section focuses on three major techniques: gastric gland isolation, parietal cell isolation, and parietal cell culture. We also discuss parietal cell physiology and pathophysiology. Second, we discuss more contemporary efforts involving confocal microscopy and gastric organoids, a new technique that holds much promise in unveiling the temporal-spatial dynamics of the cell. Finally, we will discuss findings from our laboratory where we identified an active gastric vacuolar H+-ATPase as a putative mechanism for refractory GERD. Overall, this review aims to highlight the major milestones in understanding an elusive yet important cell. Though in no way comprehensive, we hope to provide a birds-eye view to the study of this unique cell type in the gastrointestinal tract.

Editor’s Pick: Refractory Gastroesophageal Reflux Disease: Pathophysiology, Diagnosis, and Management

Gastroesophageal reflux disease (GERD) is one of the most commonly encountered gastrointestinal diseases in clinical practice. Proton pump inhibitors (PPI) remain the cornerstone of the treatment of GERD. Up to one-third of patients do not respond to optimal doses of PPI and fall into the category of refractory GERD. Moreover, the long-term use of PPI is not risk-free, as previously thought. The pathophysiology of refractory GERD is multifactorial and includes reflux related and unrelated factors. It is therefore paramount to address refractory GERD as per the aetiology of the disease for optimal outcomes. The management options for PPI refractory GERD include optimisation of PPI, lifestyle modifications, and the addition of alginates and histamine-2 receptor blockers. Neuromodulators, such as selective serotonin reuptake inhibitors or tricyclic antidepressants, may be beneficial in those with functional heartburn and reflux hypersensitivity. Laparoscopic antireflux surgeries, including Nissen’s fundoplication and magnetic sphincter augmentation, are useful in patients with objective evidence of GERD on pH impedance studies with or without a hiatal hernia. More recently, endoscopic antireflux modalities have emerged as an alternative to surgery in patients with PPI-dependent and PPI-refractory GERD. Long-term data and randomised comparison studies, however, are required before incorporating endoscopic therapies in the management algorithm for refractory GERD.

Update on the Durability and Performance of Collis Gastroplasty For Chronic GERD and Hiatal Hernia Repair At 4-Year Post-Intervention

BackgroundCollis gastroplasty (CG) remains an important procedure to lengthen the esophagus when indicated in patients undergoing fundoplication for longstanding refractory gastroesophageal reflux disease (GERD) or large hiatal hernias. Concerns over potential sequelae of CG such as dysphagia and worsening heartburn as well as questions regarding the durability of the procedure remain a subject of debate. In this study, 3 and 4-year postoperative data is presented assessing patient quality of life (QOL) measures for those undergoing laparoscopic antireflux surgery (LARS) with and without CG. MethodsComparative review of a prospectively maintained GERD patient database was conducted between patients undergoing LARS with CG versus non-CG (NC) at two institutions between October 2004 and February 2019. Patient demographic, perioperative, and QOL data was analyzed at 3 and 4 years postoperatively using four validated instruments: the Reflux Symptom Index (RSI), Laryngopharyngeal Reflux QOL (LPR-QOL), Swallowing QOL (SWAL), and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQOL) surveys. ResultsA total of 214 CG and 798 NC patients were included in this study. The CG group was older (66.1±12.9 vs. 59.0 ± 14.1, p < 0.001), had a higher frequency of ASA class 3 patients (39.7% vs. 29.7%), and had greater proportion of comorbid disease compared to NG. The groups were parallel in BMI (Collis 28.4±5.2 kg/m2 vs. non-Collis 28.6±5.3 kg/m2, p = 0.673). Subset analysis revealed persistent benefits through 4 years reflected by survey results in both groups. There were no statistically significant differences in QOL outcomes between CG and NC. A majority of patients in both groups reported discontinuation of antireflux medications and satisfaction with surgical outcomes and symptom control. ConclusionLong-term QOL outcomes after laparoscopic CG are comparable to patients treated with fundoplication alone in cases of long-standing GERD and hiatal hernias. Furthermore, CG patients enjoyed equivalent durability of the procedure without risk of subsequent dysphagia. Collis gastroplasty remains an important tool in the armamentarium of foregut surgeons.

P173 HIGH-RESOLUTION MANOMETRIC FINDINGS AFTER MAGNETIC SPHINCTER AUGMENTATION

Abstract Aim The aim of this study was to evaluate esophageal motility before and after Magnetic Sphincter Augmentation (MSA) for medically refractory Gastro-Esophageal Reflux Disease (GERD). Background and Methods MSA (LINX® Reflux Management System) is intended for patients with chronic GERD with incomplete symptom relief from proton-pump inhibitors (PPI) and abnormal acid exposure. A prospectively collected database of patients who underwent MSA between 2007 and 2019 was queried. All patients who completed pre- and post-operative high-resolution manometry (HRM) were included in the study. Additional investigations included Health-Related Quality of Life (GERD-HRQL) questionnaire, Functional Outcome Swallowing Scale (FOSS), upper gastrointestinal endoscopy, barium swallow, and 24-96 hours pH-study. Data were analyzed using Wilcoxon signed rank test and McNemar test. Results Forty-five patients met the inclusion criteria. The median follow-up was 10 months (IQR 6). Compared to baseline, there was a statistically significant reduction in PPI use (p=0.000), rate of heartburn (p=0.000), regurgitation (p=0.008), and extra-esophageal symptoms (p=0.000). Only three (6.7%) patients required dietary changes. The GERD-HRQL score significantly improved (p=0.000). There was a significant increase in the Lower Esophageal Sphincter (LES) competency, including LES length (p=0.004) and Esophago-gastric Contractile Integral ((EGJ-CI) (p=0.000). A significant increase in integrated relaxation pressure (IRP) (p=0.000), mean Distal Contractile Integral (DCI) (p=0.008) and intrabolus pressure (p=0.000) was also found. Thirteen (28.9%) patients presented pre-operative Ineffective Esophageal Motility (IEM) and five of them resolved postoperatively. Two patients (4.4%) developed IEM after surgery: both had IRP and DCI values within normal limits, and one of them complained of dysphagia. However, the GERD-HRQL score recovered in both patients. Conclusion MSA was clinically effective in relieving both typical and atypical GERD symptoms. LES competency increased after MSA. EGJ outflow obstruction was uncommon and not associated with symptoms. Finally, ineffective esophageal motility may reverse to normal after MSA.

Clinical Characterization of Vonoprazan-Refractory Gastroesophageal Reflux Disease

Introduction: The newly developed vonoprazan (a potassium-competitive acid blocker) has a greater ability to suppress gastric acid production than convention proton pump inhibitors (PPIs). The objective of the present study was to determine how vonoprazan influences the pathogenesis of refractory gastroesophageal reflux disease (GERD) in clinical practice. Methods: Between March 2013 and November 2018, a total of 73 refractory GERD patients (34 in the conventional PPI group versus 39 in the vonoprazan group) were enrolled in this retrospective study. We then compared the underlying disease conditions between the 2 groups, examined by high-resolution manometry and multichannel intraluminal impedance/pH (MII-pH) monitoring. Results: There was a significant difference in the proportion of underlying disease conditions, including erosive esophagitis, non-erosive reflux disease, reflux hypersensitivity, functional heartburn and oesophageal motility disorder (EMD), between the conventional PPI (6, 14, 23, 40 and 17% respectively) and vonoprazan groups (0, 0, 10, 49, and 41% respectively; p < 0.01). No cases of acid-related GERD were observed in the vonoprazan group. When the EMD patients were excluded, the lower oesophageal acid exposure time of the vonoprazan group (0.1% [0.0–0.5%], n = 23) was significantly lower than that of the conventional PPI group (0.35% [0.1–3.9%], n = 28; p < 0.05), and the gastric pH <4 holding time of the vonoprazan group (7.7% [0.7–34.5%]) was also significantly lower than that of the conventional PPI group (61.6% [49.4–74.3%], p < 0.01). Conclusions: Vonoprazan serves as a diagnostic tool to exclude acid-related GERD.

373 Routine EGD Has Minimal Impact on Refractory GERD Management

INTRODUCTION: Routine diagnostic esophagogastroduodenoscopy (EGD) is recommended for refractory gastro-esophageal reflux disease (GERD) symptoms despite lack of evidence that it impacts management or outcomes. This study aims to determine if diagnostic EGD impacts management in patients with refractory GERD compared to esophageal manometry, pH testing and intra-luminal impedance. METHODS: We performed an observational study of patients with refractory GERD who underwent EGD from 2013 to 2018 at a tertiary hospital. Among 1,213 patients with GERD, we strictly excluded patients with alarm features such as dysphagia, dyspepsia; history of gastroesophageal surgery, or EGD done for other diagnostic procedures, and identified 339 patients who underwent EGD solely for persistent reflux symptoms. We then identified those who had esophageal manometry or pH-impedance studies for further evaluation of GERD, as well as if the findings of these tests resulted in a change in management (medication change or de-escalation, referral for Nissen fundoplication, etc). RESULTS: Among 339 patients with refractory GERD, 80.5% of patients were taking PPIs prior to and/or at the time of EGD. The majority of patients had completely normal (163/339, 48.1%) or solely benign or incidental findings (106/339, 31.3%) on EGD. Only 10.6% of patients had esophageal manometry or pH-impedance studies for refractory reflux symptoms, of those, 6.2% followed EGD and only 7 patients had these studies after a completely normal EGD. The majority of patients undergoing manometry had normal studies or minor abnormalities (23/32, 71.8%). All patients who had been ordered for intraluminal impedance or 24 hr pH testing alone could not tolerate the procedure. Six of 15 patients (40%) undergoing 24 hr pH-impedance testing had findings leading to a change in management. Undergoing pH-impedance testing after EGD was associated with a change in management (OR 7.33, P = 0.018). PPI use was not associated DeMeester score or with results of manometry, impedance, or pH testing. CONCLUSION: Most patients who underwent EGD for refractory GERD symptoms alone did not have pathological findings prompting a change in management. There were no demographic variables that predicted pathologic findings on EGD. Very few patients underwent subsequent or concomitant esophageal manometry, impedance or pH testing. pH-impedance after EGD was associated with a change in management, and may be a better first step in evaluating patients with refractory GERD symptoms, than EGD.

867 Efficacy and Safety of Transoral Incisionless Fundoplication (TIF) in Refractory Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis

INTRODUCTION: Refractory gastroesophageal reflux disease (GERD) is common and can affect up to 40% of patients who are on proton pump inhibitor therapy. Surgical fundoplication (Nissen fundoplication) has proven to be an effective treatment option for these patients but it remains an invasive procedure in this era of minimally invasive surgery. Several endoluminal approaches to GERD management have been developed as a potential bridge between medical management and surgical fundoplication. Transoral incisionless fundoplication (TIF) is a novel endoscopic technique which has shown some promise in early studies; however, its safety profile and efficacy remain uncertain. We aimed to assess the efficacy and safety of TIF in refractory GERD through a systematic review and meta-analysis. METHODS: We performed a thorough literature search using PubMed, EMBASE, Cochrane library, Medline, Google Scholar and Science citation index between January 2010 to January 2018. Search terms included MeSH and non-MeSH terms relating to gastroesophageal reflux disease, refractory gastroesophageal reflux disease, endoscopic techniques in gastroesophageal reflux disease and transoral incisionless fundoplication. Additional case-reports, case series, and abstracts were retrieved by searching from references of relevant studies. Primary outcomes measured were cumulative technical success rate and adverse events. Secondary outcomes measured were the improvement in Gastroesophageal Reflux Symptom Score (GERSS), DeMeester score and Reflux symptom index (RSI). RESULTS: Based on our search criteria, 41 studies were identified and 6 were excluded after careful review. 35 studies which included 1586 patients (49.4% males) were analyzed. The overall technical success rate of TIF was 98.4% (95% confidence interval [CI] 96 to 99, P &lt; 0.001) and had an adverse event rate of 3.2% (95% CI 1 to 4, P &lt; 0.001). Post TIF, there was a significant improvement in GERSS score (mean difference 17.29, 95% CI 17.26 to 18.28, P &lt; 0.001), RSI (mean difference 14.37, 95% CI 13.39 to 15.19, P &lt; 0.001) and DeMeester score (mean difference 9.78, 95 % CI 8.12 to 11.89, P &lt; 0.001). CONCLUSION: TIF is a technically feasible and effective endoscopic therapeutic option for refractory GERD with good clinical responses. However, more controlled trials are required in future to compare the efficacy and safety between TIF and Nissen fundoplication.

2872 Efficacy of Robotic Dor Fundoplication on Severe Nocturnal Gastroesophageal Reflux Disease in Patients With Scleroderma

INTRODUCTION: Scleroderma is a systemic disease and its effect on the GI tract is atrophy and replacement fibrosis of the smooth muscles. The esophagus is invariably involved and approximately eighty percent of patients with scleroderma develop both gastroesophageal reflux disease (GERD) and dysphagia. The nocturnal GERD can lead to regurgitation and aspiration which further worsens the pulmonary fibrosis from scleroderma. Performing the standard fundoplication would worsen their dysphagia. Aim- Our goal was to investigate whether a Dor fundoplication (a 270-degree anterior wrap) can reduce nocturnal heartburn and regurgitation without worsening of the dysphagia in patients with scleroderma and severe GERD. METHODS: 5 scleroderma patients with drug refractory severe GERD underwent Dor fundoplication procedure (Figure 1) with a median follow up of 18 months. All had undergone a preoperative high-resolution manometry documenting very impaired esophageal motility. Patients were interviewed post operatively and were assessed for nocturnal and diurnal GERD symptoms and treatment response, status of dysphagia and adverse effects of surgery. RESULTS: All 5 patients were female with average age 50 years (range 36-65). 4 of the 5 patients (80%) reported 90% improvement in both diurnal and nocturnal GERD symptoms since surgery, they no longer suffered from nocturnal reflux, heart burn or regurgitation and that they are able to sleep well at night without requiring any more pillows or wedges. 50% of patients reported decrease in their proton pump inhibitor dosage after surgery compared to before surgery. There was no surgical complication reported and specifically no worsening of dysphagia. 100% of the patients were able to belch, burp better effectively after surgery. 4 out of 5 patients reported that they would strongly recommend this surgery to another scleroderma patient suffering from drug refractory GERD symptoms. In one patient, there was no change in symptoms after the surgery but no worsening of dysphagia. CONCLUSION: Robotic Dor fundoplication is very effective in drug refractory GERD secondary to scleroderma dominated by nocturnal regurgitation. This procedure resulted in significant symptom reduction in 80% of our patient group which in turn improved their quality of life and nocturnal sleep without affecting dysphagia.

A570 Combined Magnetic Sphincter Augmentation and Hiatal Hernia Repair for Treatment of Refractory GERD after Sleeve Gastrectomy

Magnetic sphincter augmentation (MSA) has been shown to be a safe and effective surgical option in treating medically refractory GERD. However, there is limited data evaluating the efficacy of this technique in patients with previous laparoscopic sleeve gastrectomy (LSG) and concurrent hiatal hernia. We present a novel case of managing GERD with laparoscopic MSA and hiatal hernia repair after LSG.

A560 Laparoscopic magnetic sphincter augmentation system for the treatment of severe GERD post Sleeve Gastrectomy

The laparoscopic Magnetic Sphincter Augmentation System (MSA) is a surgical technique with mid-term evidence demonstrating efficacy in the treatment of medically refractory or chronic gastroesophageal reflux disease (GERD). We present the first series of cases with severe GERD post Sleeve, that underwent this surgery. To verify the efficacy of the MSA for the treatment of pathological GERD in patients with previous sleeve gastrectomy, with no weight regain.

391 How Useful Is Prolonged 96 Hr versus 48 Hr Wireless pH Monitoring in PPI Refractory GERD?

INTRODUCTION: Gastroesophageal reflux disease (GERD) is a common problem. Ambulatory pH monitoring has been used to identify pathological esophageal acid exposure and reflux-symptoms association in GERD, especially when endoscopy is normal, but the utility of prolonged 96 hr monitoring and if PPI therapy during study facilitates better management is unclear. The purpose of the study is to evaluate the clinical utility of prolonged 96 hr wireless pH monitoring, before and after PPI therapy. METHODS: We conducted a retrospective study of adult patients presenting to our center between January 2015 and June 2018 with suspected diagnosis of GERD and refractory to PPI therapy. Consecutive patients who underwent 96 hr wireless pH monitoring (Bravo®, Medtronics, Minneapolis, MN) placed endoscopically, 6 cm above LES zone were enrolled. Patients were instructed to stop PPI therapy 7 days prior to the study and to resume their usual PPI therapy on day 3 and day 4 of study. The percent time of esophageal acid exposure (pH &lt; 4) for each day during supine and upright positions and GI symptoms were analyzed using (SPSS™) version 22. Patients were excluded if the entire 96 hr study was not recorded either from battery malfunction or capsule detachment. Data compared between those with normal and abnormal pH study, and between first 48 hrs and next 48 hrs. RESULTS: 64 patients met inclusion criteria (Table 1). 42 (65%) patients had elevated &gt;4.5%. Total 24 hr acid exposure time; 38% on either D1 or D2 and 62 % on both days and 22 (35 %) had normal acid reflux study (Figure 1, Table 2). Of patients with abnormal study, 23/42 (54.7%) had persistent increase in % acid exposure time on D3 and 17/42 (40.4%) patients on D4 following PPI therapy. CONCLUSION: Our study demonstrates that prolonged 96 hr pH monitoring is feasible and clinically useful. We confirmed abnormal acid reflux in 65% of patients and normal acid reflux in 35%. Also, the abnormal reflux profile normalized in 36% of patients on their usual PPI whereas 64% had persistent abnormal acid reflux, despite their usual PPI therapy. Thus 96 hr testing allows improved diagnosis of day time or supine acid reflux symptoms, and identifies patients who are either refractory or responsive to current PPI therapy. This test could improve management of patients with PPI refractory GERD.

1723 Esophageal Granular Cell Tumour: An Unusual Polypoid Lesion

INTRODUCTION: Esophageal granular cell tumours (GCTs) account for 1% of all Esophageal tumors and up to two-third occur in the distal third of Esophagus. Since first reported in 1931 approximately 400 cases have been reported so far. We report a case of Esophageal GCT incidentally found on endoscopic evaluation for resistant GERD. CASE DESCRIPTION/METHODS: A 42-year-old Hispanic male was seen for evaluation of refractory GERD and occasional dysphagia to solids of 3-month duration. There were no alarm symptoms or use of NSAIDs. Physical examination and labs were unremarkable. EGD was performed that showed a 4mm yellowish, sessile, subepithelial nodule with intact mucosa in the distal Esophagus (Figure 1). Biopsy showed clusters of polygonal cells with abundant granular cytoplasm that was Periodic acid–Schiff (PAS) positive suggestive of GCT. Immunohistochemical staining was positive for S100, CD 68, CD56 and Vimentin, thus conforming the diagnosis of GCT (Figure 2). EUS performed subsequently showed a 4mm, submucosal, hypoechoic, homogenous mass with no extension into muscularis propria (Figure 3); completely removed by hot snare technique with pathological conformation. Patient was discharged home with close endoscopic surveillance. DISCUSSION: Granular Cell Tumors (GCTs) arise from Schwann cells of the nerve sheath with incidence of about 0.03% and has a predilection towards skin, oral cavity and breasts. Of all GCTs, 6-8% occur in the GI tract with esophagus (65%) being the most common site. It has predilection towards females and African Americans between 40-60 years of age. Generally asymptomatic and found incidentally during endoscopy. However, GERD and dysphagia are associated with GCTs of more than 2 cm in size. EUS is invaluable in differentiating GCTs from other subepithelial tumors, determining size, depth and invasion. Biopsy/FNA can be performed during the initial endoscopy or during EUS. Definitive diagnosis is by histopathology and immunohistochemical staining. The treatment of esophageal GCTs is controversial. Conservative management is recommended for tumors &lt;1 cm, asymptomatic, no deep tissue invasion or malignancy. However, resection is warranted for symptomatic tumors, &gt;1 cm size, with deep tissue invasion or malignancy. Endoscopic removal is preferred over surgery for tumors without deep tissue infiltration or malignant. Endoscopic and histologic surveillance every 1-2 years is recommended.

370 Can Subjective GERD Questionnaires Predict Abnormal Findings in pH Impedance Testing?

INTRODUCTION: Subjective and objective tools are used to diagnose GERD, including questionnaires and 24 hour pH impedance. We examined correlations between the GERD questionnaire (GERDQ) and Reflux Symptom Index (RSI) questionnaires against component metrics of 24-hour pH impedance testing (number of reflux events, esophageal acid exposure, and symptom association). METHODS: 117 consecutive adult patients referred for PPI refractory GERD symptoms were included. All patients completed GERDQ and RSI, which are validated questionnaires for predicting GERD based on typical and atypical reflux symptoms, respectively. Patients then underwent 24 hour pH impedance testing. RSI score, GERDQ grade, pH impedance results (positive, negative), esophageal acid exposure (EAE), number of reflux events, and symptom association were variables of interest analyzed using Chi-square tests. RESULTS: A positive GERDQ result (grade C or D) was not significantly associated with abnormal pH impedance (P = 0.08). There was no correlation between positive GERDQ and abnormal EAE (P = 0.79) or number of reflux events (P = 0.26). However, positive symptom association was associated with an abnormal GERDQ (P = 0.01). Similarly, there was no significant correlation between positive RSI and abnormal pH-Imp (P = 0.06), abnormal EAE (P = 0.19), or number of reflux events (P = 0.09). Positive RSI was significantly associated with positive symptom association (P = 0.04). 58% (52/90) of patients with positive GERDQ also had positive RSI (P = 0.001). CONCLUSION: Our data suggest that positive subjective GERD assessment tools (GERDQ and RSI) are associated with positive symptom association component of pH impedance testing. However abnormal acid exposure or number of reflux episodes are more difficult to predict. Many patients report typical and atypical GERD symptoms, suggesting an overlap of symptoms. This may be exaggerated by self-report bias, and is not predictive of pH-impedance result.