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GERD clinical trials

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NCT ID: NCT01374074 Completed - Barrett's Esophagus Clinical Trials

Racial Disparity in Barrett's Esophagus

Start date: March 2011
Phase: N/A
Study type: Observational

The goal of the proposed research is to investigate the molecular mechanisms of racial disparity in Barrett's esophagus (BE), the premalignant lesion of esophageal adenocarcinoma. Specifically, the investigators hypothesize that environmental factors, genetic factors, and potentially gene environment interactions play crucial roles in the observed racial disparity in developing Barrett's esophagus. Patients are recruited through UNC hospitals prior to scheduled esophagogastroduodenoscopy (EGD). Participants complete a questionnaire, have body measurements obtained, and have blood, biopsies, and gastric aspirate collected. Participants also complete a 24 hour pH impedance test.

NCT ID: NCT01373125 Completed - Barrett's Esophagus Clinical Trials

Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?

Start date: June 2011
Phase: N/A
Study type: Observational

The investigators propose a study comparing the morphological and functional aspects of the neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE) to that of native squamous epithelium in normal controls as well as gastroesophageal reflux disease (GERD), non-Barrett's Esophagus (BE) subjects.

NCT ID: NCT01327963 Terminated - Clinical trials for Gastroesophageal Reflux Disease (GERD)

Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

RetroTIF
Start date: September 2010
Phase: N/A
Study type: Interventional

The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.

NCT ID: NCT01324986 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

A Study on the Effectiveness of Laparoscopic Fundoplication on Extraesophageal Manifestations of Gastroesophageal Reflux Disease (GERD)

Start date: n/a
Phase: N/A
Study type: Interventional

Available data regarding the effectiveness of laparoscopic antireflux surgery on extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly controversial. The aim of the present study was to evaluate the clinical effect of partial and total fundoplication on extraesophageal symptoms in a selected cohort of patients with GERD.

NCT ID: NCT01306799 Completed - Barrett's Esophagus Clinical Trials

To Learn How Bone Structure and Bone Mass Change After Long-term PPI Use

BE-CAST
Start date: January 2010
Phase: N/A
Study type: Observational

Patients with severe acid reflux and/or Barrett's esophagus are recommended to take Proton pump inhibitors (PPIs)indefinitely to prevent complications such as strictures or the development of a type of esophageal cancer. Recently, some studies suggested that taking these medications on a long-term basis may affect the bone. Therefore, it is important to learn whether these medications may lead to accelerated bone loss so that effective preventive measures can be developed for patients who require these medications for acid-related conditions. Several studies reported that patients receiving PPIs for many years may have increased risk of hip fractures. However, it is unclear whether this is because the PPIs cause reduced bone density or whether the increased risk of fractures has nothing to do with PPIs and is because patients who require PPIs have other illnesses that cause the increased fractures. The purpose of the study is to learn how bone structure and bone mass change after long-term PPI use.

NCT ID: NCT01286155 Completed - Barrett's Esophagus Clinical Trials

Epidemiology of Barrett's Esophagus: A Population Based Study

Start date: January 2010
Phase: N/A
Study type: Observational

To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's esophagus (BE) in the community. To develop a population based clinical risk factor prediction model for the diagnosis of BE and identify novel risk factors for BE which would make population based screening more efficient. This will be an important first step in identifying the target population for BE screening, another crucial component of making screening feasible and efficient

NCT ID: NCT01266551 Terminated - Clinical trials for Gastroesophageal Reflux Disease and Position

Car Safety Seat and Gastroesophageal Reflux Disease

Start date: October 2008
Phase: N/A
Study type: Interventional

What's known? Prone position is no longer a treatment option for GERD because of the association with SIDS. Originally, positioning in an infant seat was recommended for infants with GERD. However, Orenstein proved this position has a detrimental effect on GER, compared to prone positioning. What's new? Positioning in an infant seat caused no increase in GER, compared with the supine 15 degrees anti-Trendelenburg position. Except for the number of long reflux episodes, which was significantly higher in the car safety seat. Larger trials are needed for decisive conclusions.

NCT ID: NCT01265550 Completed - GERD Clinical Trials

A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors

Start date: August 13, 2012
Phase: Phase 3
Study type: Interventional

Background: Gastroesophageal reflux disease (GERD), which affects at least 20% of adult Americans, may be especially common and severe in Veteran patients. Proton pump inhibitors (PPIs), which block gastric acid production, are the most effective medications for GERD, and the VA spends more than $177 million each year on outpatient PPI prescriptions. PPIs do not prevent the reflux of non-acidic material and do not completely eliminate esophageal acid exposure, however, and bothersome GERD symptoms persist in approximately 40% of patients treated with PPIs. Recent studies using the new technique of esophageal pH/ impedance monitoring, which detects the reflux of both acidic and non-acidic materials, have shown that PPI-resistant GERD symptoms correlate with episodes of reflux (acidic and/or non-acidic) in approximately one-half of patients. For those patients, an antireflux operation might relieve symptoms and obviate the expense of ineffective PPI therapy, but the efficacy of modern, laparoscopic fundoplication in this regard is not clear. For patients with PPI-resistant GERD symptoms, furthermore, the efficacy of medications that that can prevent gastroesophageal reflux (e.g. baclofen) or diminish pain of esophageal origin (e.g. neurotropic agents like desipramine) also is not clear. Study Hypothesis: Laparoscopic antireflux surgery (Nissen fundoplication) is superior to medical therapy (PPIs plus baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring. Study Goals: The primary goal is to compare the efficacy of laparoscopic Nissen fundoplication and medical therapy (PPIs plus baclofen and desipramine) for GERD patients who, while on PPIs, have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring, and to compare the efficacy of each therapy with placebo. Secondary goals are: 1) To determine the frequency with which non-GERD disorders underlie "PPI failure," 2) To determine the frequency of functional gastrointestinal symptoms, anxiety and depression in patients who have persistent heartburn while on PPIs, 3) To determine whether functional gastrointestinal symptoms, anxiety and depression is associated with the outcomes of medical and surgical therapies, and 4) To determine whether the outcome of Nissen fundoplication is associated with adherence to technical aspects of the operation. Study Design: Up to 16 VA medical centers, there will be a 30-month recruitment period to enroll 108 patients with heartburn that is refractory to PPI therapy. Patients will have their baseline GERD symptoms scored using the GERD Health-Related Quality of Life (GERD-HRQL) index, and will have endoscopy, esophageal manometry and esophageal pH/impedance monitoring while on PPI therapy. Patients who have episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/impedance monitoring will be randomized to one of three treatment groups: Surgical Treatment (laparoscopic Nissen fundoplication), Active Medical Treatment (omeprazole and baclofen initially; desipramine for baclofen failures) or Placebo Medical Treatment (omeprazole, placebo baclofen, placebo desipramine). All patients will have quarterly clinic visits for symptom scoring and laboratory testing. At one year, patients will have a final symptom scoring and repeat endoscopy, esophageal manometry and esophageal pH/impedance monitoring. Treatment success will be defined as 50% improvement in the GERD-HRQL score at 12 months. Patients also will complete the Hospital Anxiety and Depression Scale (HADS), Rome III Functional GI Disorders Questionnaire and the Short-Form Health Survey (SF-36) at baseline and one year. The results will be correlated with treatment outcomes.

NCT ID: NCT01260935 Completed - Clinical trials for Gastroesophageal Reflux Disease

Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

Start date: November 2002
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other.

NCT ID: NCT01230944 Completed - GERD Clinical Trials

Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication

Start date: December 2004
Phase: N/A
Study type: Interventional

This is a long-term follow-up of a prospective randomized trial comparing open and laparoscopic Nissen fundoplication.