Comparison of Anti-Reflux Mucosal Ablation(ARMA) With Anti- Reflux Mucosectomy(ARMS) in Treatment of Gastroesophageal Reflux Disease- A Randomized Controlled Trial
According to the current published data and treatment mechanism, ARMS may led to more stenosis while ARMA may be less effective in long term follow-up. The changes of patient's life quality , UGI tract microbiota before and after different endoscopic treatment are also limited. So we want to conduct a exploratory prospective randomized controlled study in evaluating the mucosal healing, demand of PPI, life quality, emotion status, sleep quality, esophageal motility/ acid exposure and saliva microbiota between chronic GERD patients receiving ARMS and ARMA treatment.
NCT05422404 — Gastroesophageal Reflux Disease
Status: Not yet recruiting
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT05422404/
Important Correlation Between Anxiety and Reflux Symptoms in Patients With Gastroesophageal Reflux Disease
Gastroesophageal reflux disease (GERD) is one of the most common gastroenterological disorders with a reported prevalence of 10% to 20% percent in Europe and the USA and less than 5% in Asia. GERD manifests as heartburn, regurgitation, retrosternal pain, cough, and in some cases dysphagia and holds the possible complication of a Barrett´s esophagus. GERD can appear as non-erosive (NERD) or erosive (ERD). Comorbid symptoms of anxiety and depression are common in GERD patients: The association between anxiety or depression and reflux symptoms has been investigated in previous studies under the aspects of whether existing reflux symptomatology leads to increased anxiety and depression or whether anxiety and depression lead to more severe reflux symptoms. There is a an interaction between GERD and psychosocial disorders. A long duration of GERD was associated with higher levels of anxiety and depression, and women were more likely to have these symptoms. In patients with Barrett's esophagus, a complication of GERD in which the mucosal cells of the esophagus, under constant exposure to stomach acid, change into a different type of cell normally found in the intestinal tract, rates of anxiety and depression have been reported to be three to five times higher than in the general population. Anxiety and depression as well as adverse events in life are also independent risk factors for NERD. Patients with NERD show an increased risk for anxiety compared with patients with ERD. The reporting of somatic symptoms is multifactorial and influenced by psychosocial factors such as socioeconomic status, sex and mental distress. A high somatic symptom load is known to increase anxiety related to health issues, psychological distress and health care utilization. The increased sensation to visceral stimuli in which anxiety and depression play an important role has been discussed as visceral hypersensitivity. Several studies of patients with reflux symptoms have used the Hopsital Anxiety and Depression Scale (HADS) score as a measure of anxiety and depression and have reported higher anxiety scores than depression scores for this cohort. The aim of this study was to assess anxiety and depression levels of patients with physiological as well as with pathological DeMeester scores. Further the modulation of anxiety on the severity of reflux symptoms such as fullness, heartburn and dysphagia is examined.
NCT06151067 — Anxiety Disorders
Status: Completed
http://inclinicaltrials.com/anxiety-disorders/NCT06151067/
Efficacy and Safety of Endoscopic Anti-reflux Mucosal Ablation Therapy for Gastroesophageal reflux Disease: a Single Blind Randomized Sham Controlled Trial
The goal of this randomized clinical trial is to investigate the efficacy and safety of antireflux mucosal ablation (ARMA) for patients with refractory gastroesophageal reflux disease (GERD). The trial aim to evaluate : - Efficacy of ARMA comparing with medical treatment alone (proton pump inhibitor (PPI)), using GERD-Health Related Quality of Life Questionnaire (GERD- HRQL questionnaire), improvement of acid exposure time and DeMeester score - Safety and complications of ARMA Participants will be randomly divided into 2 groups. The intervention group will be undergone ARMA, and the control group will be undergone sham endoscopic treatment. The primary endpoint will be symptoms relief (GERD-HRQL decreases > 50%). The secondary endpoint will be dosage adjustment of PPI, complications, improvement of acid exposure time and DeMeester score.
NCT06106100 — Gastroesophageal Reflux Disease
Status: Not yet recruiting
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT06106100/
Anti-Reflux Mucosectomy (ARMS) in the Treatment of Refractory Gastro-esophageal Reflux (GERD): a Prospective Randomized Comparative Study
Gastroesophageal reflux disease (GERD) is one of the most common digestive diseases in Western countries, affecting 8% of the population in its typical and frequent form. For typical GERD without alarming symptoms, treatment combines PPI therapy and lifestyle modifications. Patients with an incomplete response to optimized PPI therapy have so-called refractory GERD. Anti-reflux mucosectomy (ARMS) is a recent technique that achieves endoscopic fundoplication by scar-induced tissue retraction using a mucosal ligation system combined with resection, known as the banded ligation system (ARM-b) [6]. Several studies have shown efficacy of approximately 65-70% on symptom resolution and quality of life improvement, including our pilot study of 21 patients, and without serious adverse events. The purpose of this study is therefore to prospectively evaluate in a randomized blinded comparison to a sham procedure and conventional medical follow-up, the efficacy of anti-reflux mucosectomy (ARMS) in the treatment of refractory GERD. The hypothesis is that we can achieve a clinical efficacy rate of 65% in the treatment group versus 35% in the control group. The primary objective is to demonstrate the superiority in terms of clinical efficacy (self-reported symptom-related GERD rate, GERD-SLR) of RAS compared to the sham procedure combined with optimized medical treatment at 1 year. The primary endpoint will be clinical efficacy, defined as a greater than 50% decrease in the number of GERD-associated symptoms, assessed using the GERD-HRQL score. Secondary objectives will be: Assessing clinical efficacy at 6 months. Assess the impact on PPI use Assess changes in procedure-induced abnormal esophageal acid exposure by Ph-metry Assess the impact of this technique on patient quality of life; To document the adverse effects of the technique (AGREE, Clavien Dindo and ASGE score) The duration of follow-up will be 1 year, and based on our hypothesis the number of patients to be included will be 130.
NCT05745012 — Gastroesophageal Reflux Disease With Ulceration
Status: Recruiting
http://inclinicaltrials.com/gastroesophageal-reflux-disease-with-ulceration/NCT05745012/
Simultaneous Evaluation of Endoscopic Features in Patients Suffering From Gastroesophageal Reflux: Functional Endoscopy Gives Insight for ENT (Ear-nose-throat) and GI Alterations - a Prospective Study
Patients suffering from gastroesophageal reflux may suffer from both esophageal and laryngeal irritations. The investigators developed an endoscopic technique called functional endoscopy to evaluate alterations in the larynx and pharynx as well as in the esophagus simultaneously as one-stop-shop.
NCT05634187 — Reflux, Gastroesophageal
Status: Completed
http://inclinicaltrials.com/reflux-gastroesophageal/NCT05634187/
Evaluating Gastro-oesophageal Reflux After Palliative Stenting for Malignant Distal Oesophageal Obstruction Using Anti-Reflux Stents: a Randomised Controlled Trial
Incurable oesophageal cancer remains a global problem and in South Africa the vast majority of patients with oesophageal cancer have advanced disease at first presentation and are not curable. Likely the most distressing symptom of advanced cancer in the oesophagus is dysphagia, which is the inability to swallow solids and later also liquids. This is successfully addressed in most cases by the placement of a stent in the oesophagus which opens the area of obstruction. When placed in the lower oesophagus, one of the major drawbacks of these stents is that they disrupt the anti-reflux mechanism of the oesophago-gastric junction, which can result in severe acid reflux, severely impacting the quality of life of the patient. To address this problem, a range of approved anti-reflux stents have been developed and tested in numerous trials. To date, the evidence is conflicting and there is insufficient current evidence to support the routine use of these stents. However, the trials are not all similar in how the acid reflux was measured or what type of stent was used. Furthermore, the use of anti-reflux medication, such as proton pump inhibitors, which may help reduce reflux, are not standardised across the trials and make further conclusions about these stents difficult to interpret. No data from Sub-Saharan Africa on the use of anti-reflux stents in these patients is available. South Africa faces a large burden of incurable oesophageal cancer and improving the quality of life of these patients is of paramount importance. This randomised controlled trial aims to investigate whether anti-reflux stents do indeed reduce acid reflux in patients with incurable oesophageal cancer compared to conventional oesophageal stents that do not have such an anti-reflux mechanism. Reflux will be measured using patient questionnaires about reflux, and other quality of life parameters, and will also be objectively measured using oesophageal scintigraphy, which has not been used in previous similar trials.
NCT05303298 — Esophageal Cancer
Status: Recruiting
http://inclinicaltrials.com/esophageal-cancer/NCT05303298/
A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux Before Anti-Reflux Surgery or Endoscopic Treatment
The purpose of this study was to evaluate the safety and efficacy of endoscopic endoloop pre-test for gastroesophageal reflux before anti-reflux surgery or endoscopic treatment. In the study, the investigators used the novel pre-test to narrow the gastric cardia to control symptoms temporarily to decide whether to undergo irreversible surgery or endoscopic treatment.Thirty patients were enrolled and underwent endoscopic endoloop pre-test treatment. The Primary outcome in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. The secondary outcomes included improvement in esophageal 24-hr pH monitoring, improvement in quality of life questionnaires and safety. Patient follow-up assessments were completed at 7 and 14 days post treatment.
NCT05192538 — GERD
Status: Recruiting
http://inclinicaltrials.com/gerd/NCT05192538/
Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
MGB is considered to be the best alternative to Roux-en-Y gastric bypass (RYGB) due to the shorter operation time and fewer possible complications. The purpose of this study was to determine biliary reflux in patients undergoing MGB/OAGB with a hand-sewn gastroenteroanastomosis, and MGB/OAGB with a stapler gastroenteroanastomosis.
NCT04845438 — Bile Reflux
Status: Recruiting
http://inclinicaltrials.com/bile-reflux/NCT04845438/
Randomized Sham-Controlled Trial of the Reflux Band in Laryngopharyngeal Reflux (LPR)
This 12 week biomarker targeted double blind randomized controlled trial (RCT) will enroll subjects with salivary pepsin positive laryngopharyngeal reflux (LPR) to assess efficacy of the external upper esophageal sphincter (UES) compression device, also known as the Reflux Band. Subjects will be randomized to one of two arms: control or experimental. Following the 8 week intervention period subjects in both arms will continue in a 4 week unblinded period. The primary hypothesis is that a significantly higher proportion of subjects in the experimental arm will meet the primary endpoint for symptom response, compared to subjects in the control arm.
NCT04827355 — Laryngopharyngeal Reflux
Status: Recruiting
http://inclinicaltrials.com/laryngopharyngeal-reflux/NCT04827355/
Oesophageal Manometry and Ambulatory Reflux Monitoring Predictors of Clinical Outcomes After Anti-Reflux Surgery
Gastro-oesophageal reflux disease (GORD) is a common condition, where acid from the stomach leaks up into the oesophagus (gullet) and causes symptoms such as heartburn and an unpleasant taste in the back of the mouth. GORD can often be controlled with self-help measures and medication. Occasionally, surgery to correct the problem may be needed. A laparoscopic fundoplication is a keyhole (laparoscopic) procedure which is a highly effective treatment. Although reflux-related symptoms are absent or well controlled in over 85% of patients at 5 years after the operation, younger patients may have higher expectations that such an operation would hopefully last decades. Oesophageal physiology tests such as 24-hour catheter pH (potential of hydrogen) and impedance involve passing a small tube into oesophagus via patients' nose to monitor the presence of stomach content (acid or non-acid) in the oesophagus. The manometry test measures the pressures and coordination of pressure activity within the oesophagus. Bravo™ wireless pH monitoring uses a capsule that is attached to the oesophageal lining. These tests are often used as part of a pre-operative evaluation before anti-reflux surgery (ARS). Several measurements in these tests (also called parameters) could potentially anticipate clinical outcomes following anti-reflux surgery. The evidence for parameters like duration of acid exposure, number of reflux episodes and association with symptoms, pressures and co-ordination of pressure activity in the oesophagus, came from studies which were not designed in the most rigorous way to determine whether a cause-effect relation exists between treatment and outcome. This is a single centre, retrospective, observational study in which patients who had pre-operative physiology testing and anti-reflux surgery at a tertiary centre in the last 10 years will be assessed for reflux symptoms and quality of life over the phone, based on three validated questionnaires. The study is designed to evaluate correlations between oesophageal physiology parameters and symptomatic response to ARS.
NCT03390634 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT03390634/