Refractory Gastroesophageal Reflux Disease Research Articles

Budget Impact of RefluxStop™ as a Treatment for Patients with Refractory Gastro-oesophageal Reflux Disease in the United Kingdom.

Background: Gastro-oesophageal reflux disease (GORD) is a common condition associated with heartburn and regurgitation. Standard of care for GORD patients in the UK involves initial treatment with proton pump inhibitors (PPIs) and laparoscopic antireflux surgery in patients unwilling to continue or intolerant of long-term PPI treatment. Recently, RefluxStop™, a novel, implantable medical device, has proven to be an efficacious and cost-effective treatment for patients with GORD. The current analysis aimed to describe the budget impact of introducing RefluxStop™ within National Health Service (NHS) England and Wales. Objectives: To estimate the more immediate, short-term clinical and economic effects of introducing RefluxStop™ as a therapeutic option for patients with GORD treated within NHS England and Wales. Methods: A model adherent to international best practice guidelines was developed to estimate the budget impact of introducing RefluxStop™ over a 5-year time horizon, from an NHS perspective. Two hypothetical scenarios were considered, one without RefluxStop™ (comprising PPI treatment, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation using the LINX® system) and one with RefluxStop™ (adding RefluxStop™ to the aforementioned treatment options). Clinical benefits and costs associated with each intervention were included in the analysis. Results: Over 5 years, introducing RefluxStop™ allowed the avoidance of 347 surgical failures, 39 reoperations, and 239 endoscopic esophageal dilations. The financial impact of introducing RefluxStop™ was £3 029 702 in year 5, corresponding to a 1.68% increase in annual NHS spending on GORD treatment in England and Wales. Discussion: While the time horizon was too short to capture some of the adverse events of PPIs and complications of GORD, such as the development of Barrett's esophagus or esophageal cancer, the use of RefluxStop™ was associated with a substantial reduction in surgical complications, including surgical failures, reoperations, and endoscopic esophageal dilations. This favorable clinical profile resulted in cost offsets for the NHS and contributed to the marginal budget impact of RefluxStop™ estimated in the current analysis. Conclusions: Introducing RefluxStop™ as a treatment option for patients with GORD in England and Wales may be associated with clinical benefits at the expense of a marginal budget impact on the NHS.

Budget Impact of RefluxStopTM as a Treatment for Patients with Refractory Gastro-oesophageal Reflux Disease in the United Kingdom

Background: Gastro-oesophageal reflux disease (GORD) is a common condition associated with heartburn and regurgitation. Standard of care for GORD patients in the UK involves initial treatment with proton pump inhibitors (PPIs) and laparoscopic antireflux surgery in patients unwilling to continue or intolerant of long-term PPI treatment. Recently, RefluxStop™, a novel, implantable medical device, has proven to be an efficacious and cost-effective treatment for patients with GORD. The current analysis aimed to describe the budget impact of introducing RefluxStop™ within National Health Service (NHS) England and Wales. Objectives: To estimate the more immediate, short-term clinical and economic effects of introducing RefluxStop™ as a therapeutic option for patients with GORD treated within NHS England and Wales. Methods: A model adherent to international best practice guidelines was developed to estimate the budget impact of introducing RefluxStop™ over a 5-year time horizon, from an NHS perspective. Two hypothetical scenarios were considered, one without RefluxStop™ (comprising PPI treatment, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation using the LINX® system) and one with RefluxStop™ (adding RefluxStop™ to the aforementioned treatment options). Clinical benefits and costs associated with each intervention were included in the analysis. Results: Over 5 years, introducing RefluxStop™ allowed the avoidance of 347 surgical failures, 39 reoperations, and 239 endoscopic esophageal dilations. The financial impact of introducing RefluxStop™ was £3 029 702 in year 5, corresponding to a 1.68% increase in annual NHS spending on GORD treatment in England and Wales. Discussion: While the time horizon was too short to capture some of the adverse events of PPIs and complications of GORD, such as the development of Barrett’s esophagus or esophageal cancer, the use of RefluxStop™ was associated with a substantial reduction in surgical complications, including surgical failures, reoperations, and endoscopic esophageal dilations. This favorable clinical profile resulted in cost offsets for the NHS and contributed to the marginal budget impact of RefluxStop™ estimated in the current analysis. Conclusions: Introducing RefluxStop™ as a treatment option for patients with GORD in England and Wales may be associated with clinical benefits at the expense of a marginal budget impact on the NHS.

Anti-reflux mucosal ablation for refractory gastroesophageal reflux disease after Roux-en-Y gastric bypass.

Anti-reflux mucosal ablation for refractory gastroesophageal reflux disease after Roux-en-Y gastric bypass.

Transoral incisionless fundoplication with or without hiatal hernia repair for gastroesophageal reflux disease after peroral endoscopic myotomy.

Background and study aims Gastroesophageal reflux disease (GERD) following peroral endoscopic myotomy (POEM) occurs in 40% to 60% of patients. There are limited data evaluating antireflux surgery or transoral incisionless fundoplication (TIF) for refractory post-POEM GERD. Patients and methods In a single-center prospective cohort study, consecutive patients with medically refractory post-POEM regurgitation and/or GERD treated with TIF or combined laparoscopic hernia repair and TIF (cTIF) were evaluated. Baseline evaluation: GERD-Health Related Quality of Life (GERD-HQRL) and Reflux Symptom Questionnaire 7-day recall (RESQ-7) questionnaires, EGD, high-resolution manometry (HRM), 48-hour pH test off proton pump inhibitors (PPIs) and impedance planimetry of the esophagogastric junction (EGJ) to calculate the diameter distensibility index (EGJ-DI). A PPI was taken twice daily for 2 weeks after TIF and restarted later if required. Patients returned 9 to 12 months after treatment when all preoperative studies were repeated. Quality of life, pH studies and EGJ metrics before and after antireflux surgery were compared. Results Seventeen patients underwent TIF (n=2, 12%) or cTIF (n=15, 88%) a mean 25±15 months after POEM. At follow-up a mean of 9±1 months after TIF/cTIF, patients required less frequent daily PPIs (n=0.001), were more satisfied (P=0.008), had improved GERD-HQRL (P=0.001), less intensity and frequency of GERD (P=0.001) and fewer reflux episodes (P=0.04) by pH testing. There was no change in EGJ-DI, EGJ diameter, integrated relaxation pressure, % total time pH <4, or DeMeester score. Conclusions TIF and cTIF for difficult-to-control post-POEM GERD appear safe, decrease PPI use and reflux episodes, and improve QOL without significant change in IRP, EGJ compliance, diameter or esophageal acid exposure time.

Diagnosis of Celiac Disease in a Patient with Isolated Refractory Dyspepsia and GERD: A Case Report

Celiac disease is a chronic autoimmune illness that develops in genetically susceptible persons who consume gluten that causes damage to the small intestine. The average global prevalence of CD is between 0.5 and 1%, despite regional variations in the disease's frequency. In this report, we present a 34-year-old patient with a complaint of epigastric pain and burning with a history of nausea and vomiting. She complained of severe gastric pain, bloating, discomfort, burning, and digestive problems. Endoscopy and colonoscopy were performed due to her lower abdominal pain and it showed that the asymptomatic with isolated dyspepsia patient was diagnosed with celiac disease. Every six months, anti-TCG, IgG, and IgA levels were monitored and they improved at the same time that the patient's symptoms did. Endoscopy must be performed in young patients, who have no signs of celiac disease and have a positive laboratory test.

Clinical efficacy of Yukgunja-tang combined with a proton pump inhibitor for refractory gastroesophageal reflux disease: study protocol for randomized, double-blind, double-dummy clinical trial

BackgroundYukgunja-tang (YGJ) is an herbal prescription used to treat the symptoms of gastroesophageal reflux disease (GERD). Although many preclinical and clinical studies on YGJ have been conducted on GERD, there is a lack of evidence from blinded studies to exclude placebo effects. Therefore, this protocol proposes a clinical trial that is single-centered, randomized, double-blinded, double-dummy to objectively evaluate the efficacy and safety of co-administered YGJ and rabeprazole (RPZ) in patients with GERD previously treated with proton pump inhibitors (PPIs) and still experiencing symptoms.MethodsA total of 86 participants with refractory GERD (rGERD) will be randomized in a 1:1 ratio to the treatment [YGJ and RPZ (10 mg/d)] and control groups [double-dose RPZ (20 mg/d)] for 4 weeks of treatment (weeks 0–4) followed by 4 weeks of follow-up (weeks 4–8). The Frequency Scale for the Symptoms of GERD will be analyzed for the primary endpoint. Reflux Disease Questionnaire, Reflux Symptom Score, GERD-Health Related Quality of Life, Overall Treatment Evaluation, Spleen Qi Deficiency Questionnaire, Damum Questionnaire, and dyspepsia Visual Analogue Scale will be used to evaluate treatment effects on GERD related symptoms and quality of life and to compare treatment effects by subgroups. Safety tests will be analyzed by investigating adverse events.DiscussionThis clinical trial will be the first rigorous double-blind, double-dummy, placebo-controlled study to precisely evaluate the efficacy and safety of the combination of YGJ and PPIs in the treatment of rGERD. The results of this study will provide a reliable clinical basis for selecting botanical drug treatments for patients with rGERD.Trial registrationClinical Research Information Service (registration number: KCT0008600, July 13, 2023, https://cris.nih.go.kr).

Endoscopic anti-reflux mucosectomy (ARMS) and endoscopic anti-reflux ablation (ARMA) as a potential treatment for gastroesophageal reflux - preliminary report.

&lt;b&gt;&lt;br&gt;Introduction:&lt;/b&gt; Gastroesophageal reflux (GERD) is one of the most common disorders of the alimentary tract. Apart from troublesome symptoms, untreated GERD can lead to Barrett's esophagus and, as a consequence, esophageal adenocarcinoma. As for now, the most common treatment of GERD is PPI pharmacotherapy. However, in a number of cases, this treatment is not sufficient or the patient does not tolerate PPI-group drugs. In such cases, interventional therapy is recommended. So far, laparoscopic fundoplication has been the only suggested option. Other, minimally invasive procedures such as Stretta, MUSE, TIFF, or EsophyX were not recommended due to the lack of clinical data. In 2014, Professor H.Inoue from the Digestive Diseases Center, Showa University in Japan reported on the first series of novel, endoscopic, anti-reflux procedures: anti-reflux mucosectomy (ARMS) and anti-reflux mucosal ablation (ARMA).&lt;/br&gt; &lt;b&gt;&lt;br&gt;Methods:&lt;/b&gt; We conducted our prospective, single-center study in 30 patients (14 female, 16 male) with PPI-refractory GERD. All patients underwent FSSG and GERD-HRQL evaluation and GE junction pressure study prior, 6 weeks and 6 months after the procedures. After the procedure, all patients received PPI treatment for 4 weeks.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Results:&lt;/b&gt; We successfully completed the procedures in all 30 patients. The mean procedure time was 42 minutes. No complications occurred. In 86.67% (26) of our patients, we achieved total remission of GERD symptoms, FSSG scores &lt; 6 and GERD-HRQL scores &lt; 8.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Conclusions:&lt;/b&gt; The results of our study show that ARMS and ARMA are simple, safe, improve GERD-related symptoms, and restore the GE junction's anti-reflux capacity.&lt;/br&gt.

Antireflux mucoplasty, an evolution of endoscopic antireflux therapy for refractory GERD

Video 1We present a new therapeutic approach called antireflux mucoplasty for proton pump inhibitor-refractory GERD.

S512 Effect of Esomeprazole Dual Release Gastro-Resistant Tablets in Patients With Refractory Gastroesophageal Reflux Disease in Comparison to Esomeprazole Tablets: A Double-Blind Randomized, Phase 3 Active-Controlled Trial

S512 Effect of Esomeprazole Dual Release Gastro-Resistant Tablets in Patients With Refractory Gastroesophageal Reflux Disease in Comparison to Esomeprazole Tablets: A Double-Blind Randomized, Phase 3 Active-Controlled Trial

S613 Treatment of Bile Reflux Phenotype Improved Response to Treatment in PPI Refractory GERD Patients

S613 Treatment of Bile Reflux Phenotype Improved Response to Treatment in PPI Refractory GERD Patients

The Safety and Efficacy of Acid Suppression Therapy in Neonatal GERD

Gastroesophageal reflux (GER) is a common physiologic process in infants that often resolves with growth and maturation, while gastroesophageal reflux disease (GERD) is a serious and common referral disease in infants and neonates. The first-line treatment for both GER and GERD is conservative therapy. H2RAs and PPIs are the two basic pharmacologic agents in the treatment of GERD in pediatrics and adults. The efficacy of PPIs is higher than that of H2RAs in GERD treatment. There are controversies in the pharmacologic treatment of neonatal GERD, and performing more clinical trials to survey the effect of PPIs and H2RAs and compare them with each other is necessary in this age group. We conducted three different clinical trials to compare the efficacy and safety of ranitidine with omeprazole or lansoprazole in refractory neonatal GERD.

Correlation between Psychosomatic Assessment, Heart Rate Variability, and Refractory GERD: A Prospective Study in Patients with Acid Reflux Esophagitis.

Gastroesophageal reflux disease (GERD) affects a significant proportion of individuals, with life stress being a contributing factor. This study aimed to investigate the correlation between psychosomatic evaluations, heart rate variability (HRV), and GERD in a cohort of individuals. Additionally, the study aimed to analyze the sequencing changes following proton pump inhibitor (PPI) treatment and identify predictive factors associated with refractory GERD. A prospective cohort of 105 individuals with reflux esophagitis and a control group of 50 participants without acid reflux symptoms were enrolled. Psychosomatic evaluations, including GERDQ, GERDQLQ, RSI, BAI, BDI, and SSS-8, were assessed at baseline and during treatment. HRV parameters were also evaluated. Multivariate analysis was used to identify predictive factors for refractory GERD. PPIs were administered regularly for the initial 2 months and then used on-demand. Refractory GERD was defined as less than 50% improvement in symptom relief or GERDQLQ score ≥ 20 after 8 weeks of PPI treatment. The GERD group had higher scores in all psychosomatic evaluations compared to the control group (all p-values < 0.001). There were no significant changes in any parameters of HRV before and after treatment in the GERD group. Strong and consistent correlations were observed between GERD symptoms and psychological scores (BAI, BDI, and SSS-8) across all time points (W0, W4, and W8). Sequential reductions in GERD symptom scores and psychosomatic evaluations were observed during the initial eight weeks of treatment. Higher GERDQ (≥10) and SSS-8 (≥12) scores were predictive of refractory GERD (p = 0.004 and p = 0.009, respectively). This study emphasizes the importance of considering physiological and psychological factors in the management of GERD. Psychosomatic evaluations provide valuable insights for assessing and treating GERD patients. Integrating stress management and comprehensive assessments into personalized treatment strategies is crucial.

Revisional Roux-en-Y Gastric Bypass After Sleeve Gastrectomy for Gastro-esophageal Reflux Disease and or Insufficient Weight-Loss: a Comparative Study.

Sleeve gastrectomy (SG) is a popular surgical weight-loss procedure, but there are increasing reports of revisional Roux-Y-gastric-bypass (R-RYGB) to manage weight-loss failure (WLF) or proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) after SG, with little data available in these settings. This retrospective study included all consecutive patients undergoing R-RYGB for WLF or RGERD after SG in two bariatric care centers from 2012 to 2018. Of 720 patients, 46 (3.6%) underwent R-RYGB (RGERD, n = 25; 54.4%; WLF, n = 21; 45.6%) within 44.8 ± 27.5months post-SG. SG had enabled 27% ± 11.6 total weight loss (TWL) in the RGERD group vs. 7.2% ± 12.5% TWL in the WLF group (p < 0.001). At R-RYGB, WLF-group patients had a higher BMI (47.8 ± 8.4 vs. 34.7 ± 6.1kg/m2; p < 0.001) and a higher number of comorbidities (2.4 ± 1.5 vs 1.5 ± 1.2; p < 0.02) compared to RGERD-group patients, while severe morbidity (Clavien-Dindo ≥ IIIb) was not significantly different between groups (6.5% vs 2.1%, p = 0.6). %TWL was still higher in the RGERD group at 12months post-R-RYGB (35.6% ± 10.4 vs. 23.8% ± 9.2; p < 0.01) but not after 24months post-R-RYGB. R-RYGB corrected reflux symptoms in 32 (94%) patients and reduced PPI use in 29 (97%) patients (p < 0.001), with no significant between-group difference. A history of adjustable gastric banding (AGB) (N = 8;17.4%) prior to SG was associated with a similar prevalence of GERD at R-RYGB and a lower %TWL (AGB:13.1 ± 10.2 vs. No AGB:31.6 ± 8.5; p < 0.05) at 3years post-R-RYGB. R-RYGB following SG provides remission of reflux symptoms in 94% of patients and extra weight loss in patients with WLF, except in patients with a history of AGB prior to SG.

Diagnosis and Treatment of Refractory GERD

Diagnosis and Treatment of Refractory GERD

Gastroesophageal reflux disease in bronchial asthma: What we need to know?

Gastroesophageal reflux disease (GERD) is most common disease with variable presentation from asymptomatic to frank symptomatic disease having impact on various respiratory disease such as cough, bronchitis, bronchial asthma, chronic obstructive pulmonary disease, and interstitial lung diseases. GERD is defined by retrograde reflux of gastric contents to the esophagus leading to various signs and symptoms that range from heartburn/ regurgitation to the development of extraesophageal respiratory syndromes like asthma. Bronchial asthma and GERD are more common diseases and usually reported more frequently as “two side sides of same coin.” GERD has been associated with a causal link for asthma, worsening of asthma control, one of the causes for refractory asthma, and a main factor in asthma cases with recurrent asthma exacerbation. Asthma itself and medicines used for the treatment of asthma are associated with GERD, worsening of GERD and one of the causes for refractory GERD. However, asthmatics have been found to have a much greater prevalence of GERD symptoms than the general population. There remains debate regarding the underlying physiologic mechanism of this relationship and whether treatment of GERD actually translates into improved asthma outcomes. The clinical prevalence of the two conditions in many patients cannot be ignored, and multiple theories highlighting plausible pathogenic explanations for these associations have been described. The treatment of symptomatic GERD in patients with asthma is important to control the underlying GERD and should be undertaken based on current guidelines for the treatment of the GERD.

Ligamentum teres cardiopexy for post vertical sleeve gastrectomy gastroesophageal reflux.

Vertical sleeve gastrectomy (VSG) evolved in the early 2000s into the standalone weight loss procedure we see today. While numerous studies highlight VSG's durability for weight loss, and improvements co-morbidities such as type 2 diabetes mellitus and cardiovascular disease, patients with gastroesophageal reflux disease (GERD) have been counseled against VSG due to the concern for worsening reflux symptoms. When considering anti-reflux procedures, VSG patients are unable to undergo traditional fundoplication due to lack of gastric cardia redundancy. Magnetic sphincter augmentation lacks long-term safety data and endoscopic approaches have undetermined longitudinal benefits. Until recently, the only option for patients with a history of VSG with medically refractory GERD has been conversion to roux en Y gastric bypass (RNYGB), however, this poses other risks including marginal ulcers, internal hernias, hypoglycemia, dumping syndrome, and nutritional deficiencies. Given the risks associated with conversion to RNYGB, we have adopted the ligamentum teres cardiopexy as an option for patients with intractable GERD following VSG. A retrospective chart review was conducted of patients who had prior laparoscopicor robotic VSG and subsequently GERD symptoms refectory to pharmacological management who underwent ligamentum teres cardiopexy between 2017 and 2022. Pre-operative GERD disease burden, intraoperative cardiopexy characteristics, post-operative GERD symptomatology and changes in H2 blocker or PPI requirements were reviewed. Of the study's 60 patients the median age was 50years old, and 86% were female. All patients had a diagnosis of GERD through pre-operative assessments and were taking antisecretory medication. Of the 36 patients who have completed their one year follow up, 81% of patients had either a decrease in dosage or cessation of the antisecretory medication at one year following ligamentum teres cardiopexy. Ligamentum teres cardiopexy is a viable alternative to RNYGB in patients with a prior vertical sleeve gastrectomy with medical refractory GERD.

Endoscopic treatment of gastroesophageal reflux: a narrative review.

Gastroesophageal reflux disease (GERD) is a common chronic disease that affects one-third of the population worldwide. In recent years, there have been significant advances for diagnostic workup, which leads to better identification of reflux-related complications. Classically, the mainstay of therapy has been proton pump inhibitor and lifestyle and dietary modifications. For refractory GERD the gold-standard therapies are surgical antireflux procedures. Recently, endoscopic procedures have emerged as safe and efficient alternatives to surgery. These could represent a less invasive approach, with scarce morbidity and with a well-tolerated profile. Each of the existing endoscopic techniques for the treatment of GERD are addressed in this report, highlighting their potential advantages, aiming at helping decide the best management of these patients. Future studies, with larger numbers of patients, may allow a definitive role for these techniques in the management of GERD to be established.

Psychological symptoms do not discriminate between reflux phenotypes along the organic-functional refractory GERD spectrum

ObjectiveHistorically, psychological processes are associated with disorders at the functional end of the gastro-oesophageal reflux disease (GERD) spectrum. However, recent research suggests that psychological symptoms are relevant across the entire...

Randomized Controlled Trial of Anti-reflux Mucosectomy Versus Radiofrequency Energy Delivery for Proton Pump Inhibitor-refractory Gastroesophageal Reflux Disease.

The efficacy and safety of anti-reflux mucosectomy (ARMS) or radiofrequency energy delivery in the treatment of gastroesophageal reflux disease (GERD) have been reported, but the difference between the 2 remains unclear. This was a single center, randomized, comparative clinical study. Patients with symptoms of heartburn and/or regurgitation despite proton pump inhibitor treatment were randomly assigned to either ARMS group (n = 20) or radiofrequency group (n = 20). Primary outcome was the standardized GERD questionnaire (GERDQ) at 2 years after the procedures. Secondary outcomes were the proportions of patients with complete proton pump inhibitor (PPI) cessation and patients satisfied with the treatment. A total of 18 patients randomized to ARMS and 16 to radiofrequency were analyzed in this study. The operation success rate of the 2 groups was 100%. In both ARMS and radiofrequency groups, GERDQ scores at 2 years after the procedures were significantly lower than that before operation (P = 0.044 and P = 0.046). At 2 years postoperatively, the scores of GERDQ did not differ between the 2 groups (P = 0.755). There was no significant difference in the rate of discontinuation of PPIs and patient satisfaction in the ARMS and radiofrequency groups (P = 0.642 and P = 0.934). The clinical efficacy of ARMS and radiofrequency for the PPI-refractory GERD is equivalent. ARMS, the efficacy of which could be maintained for at least 2 years, is promising endoscopic management for the treatment of refractory GERD.

A038 Recurrent, Refractory GERD and Dysphagia after Roux-en-y Gastric Bypass with Preserved Nissen Fundoplication: A Demonstration of Fundoplication Reversal, Hiatal Hernia Repair, and Revision Gastrojejunostomy

A038 Recurrent, Refractory GERD and Dysphagia after Roux-en-y Gastric Bypass with Preserved Nissen Fundoplication: A Demonstration of Fundoplication Reversal, Hiatal Hernia Repair, and Revision Gastrojejunostomy