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Trial record 3 of 6 for:    10403727 [PUBMED-IDS]

Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study

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ClinicalTrials.gov Identifier: NCT02081404
Recruitment Status : Recruiting
First Posted : March 7, 2014
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
PRATEEK SHARMA, Midwest Biomedical Research Foundation

Brief Summary:
Gastroesophageal reflux disease (GERD), a common chronic disorder in the veteran population, is associated with drug costs exceeding $ 10 billion/year. Only 30-40% of patients with reflux symptoms have erosive esophagitis. The vast majority suffers from non erosive reflux disease (NERD), a condition in which standard endoscopy fails to identify any mucosal breaks and is unable to confirm the diagnosis. Unfortunately, a gold standard for the diagnosis of NERD does not exist. Narrow band imaging (NBI) utilizes spectral narrow band filters (incorporated into standard endoscopes) and helps to see abnormal areas not identified during standard endoscopy. Preliminary results have shown that NBI endoscopy may represent a significant improvement over standard endoscopy for the diagnosis of NERD. The purpose of this study is to accurately diagnosis non acid reflux disease by using a blue light (also known as NBI)upper endoscopy technique.

Condition or disease Intervention/treatment Phase
Non-erosive Reflux Disease Drug: Esomeprazole Drug: Placebo Not Applicable

Detailed Description:

Gastroesophageal reflux disease (GERD), a common chronic disorder in the veteran population, is associated with drug costs exceeding $ 10 billion/year. Only 30-40% of patients with reflux symptoms have erosive esophagitis. The vast majority suffers from NERD; a condition in which standard endoscopy fails to identify any mucosal breaks and is unable to confirm the diagnosis. Unfortunately, a gold standard for the diagnosis of NERD does not exist. 24-hour esophageal pH monitoring and histologic esophageal mucosal changes in NERD patients have limited accuracy to be routinely used in clinical practice.

Narrow band imaging (NBI) utilizes spectral narrow band filters (incorporated into standard endoscopes) and enables imaging of features such as intrapapillary capillary loops (IPCLs); features not identified during standard endoscopy. Preliminary results have shown that NBI endoscopy may represent a significant improvement over standard endoscopy for the diagnosis of NERD. Our hypothesis is that NBI identifies changes in the distal esophagus that are specific for diagnosing patients with NERD. Specific Aim #1: To compare NBI features in the distal esophagus in patients with NERD (cases) and controls. Specific Aim #2: To determine whether the NBI features in NERD patients resolve after PPI therapy. Specific Aim #3: To correlate NBI findings with esophageal histology. Specific Aim #4: To assess the intra- and interobserver agreement for recognition of the proposed criteria for diagnosing NERD. Cases will be defined as patients with reflux symptoms (assessed by two validated questionnaires) with absent macroscopic erosions and abnormal esophageal pH results (NERD group). Control subjects will include patients with no reflux symptoms, absent macroscopic erosions and a normal esophageal pH result. To identify NBI findings as predictors of response, response to therapy in cases randomized to the PPI arm will be assessed using a validated GERD questionnaire and correlated with IPCL number and presence of microerosion. In addition, NBI findings in patients with reflux symptoms, no macroscopic erosions and normal esophageal pH result will also be compared with controls. Two biopsies will be obtained from the distal esophagus along with digital images and videorecordings.

Statistical analysis will be done as follows: Aim 1 - chi-square and t-test; with logistic regression and calculation of odds ratios, Aim 2- McNemar's test and kappa statistic, Aim 3- Spearman's correlation coefficient and Aim 4- intraclass correlation coefficient. Potential impact on Health Care: GERD is common among patients and by obviating the need for additional investigations and reducing unnecessary drug costs, NBI endoscopy could have a considerable positive impact on patients with NERD.

VA Project


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Diagnosis of Acid Reflux Disease Using Novel Imaging: A Prospective Study
Study Start Date : March 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Heartburn

Arm Intervention/treatment
Active Comparator: Esomeprazole
proton pump inhibitor
Drug: Esomeprazole
standard dose of proton pump inhibitor by mouth once a day for 30 days
Other Name: Nexium

Placebo Comparator: Placebo
placebo
Drug: Placebo
placebo
Other Name: inactive substance




Primary Outcome Measures :
  1. NBI endoscopy identifies changes in the distal esophagus that are specific for diagnosing patients with Non-Esophageal Reflux Disease. [ Time Frame: 10 weeks ]
    1. Proportion of patients with NBI abnormalities in the NERD group vs. controls.
    2. Proportion of patients with resolution of NBI abnormalities after PPI therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age
  • Capable of giving informed consents.
  • Cases of NERD will be recruited on the basis of presence of heartburn and/or regurgitation using two validated GERD questionnaires in conjunction with an abnormal esophageal pH result and absence of erosions at standard endoscopy.
  • Control subjects will include patients referred for an upper endoscopy for evaluation of non-reflux symptoms such as iron deficiency anemia, heme positive stools, screening of esophageal varices amongst others. A negative esophageal pH result and absence of erosions will be inclusion criteria for these patients.

Exclusion Criteria:

  • Presence of macroscopic erosive esophagitis
  • Pregnancy/lactation
  • Chronic anticoagulation
  • Patients with significant medical comorbidities (oxygen dependent chronic obstructive pulmonary disease, NYHA class III or IV congestive heart failure, recent diagnosis of cancer with a life-expectancy < 5 years)
  • History of Barrett's esophagus
  • Presence of columnar lined distal esophagus on endoscopy with intestinal metaplasia
  • Presence of cancer or mass lesion in the esophagus or stomach
  • Esophageal strictures
  • Peptic ulcer disease and Helicobacter pylori infection
  • Prior history of esophageal surgery
  • Allergic to PPIs
  • Patients on drugs known to cause pill-related esophagitis (e.g. potassium supplements)
  • Patients with HIV or other immunocompromised conditions who may have infectious esophagitis
  • Eosinophilic esophagitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081404


Contacts
Contact: April D Higbee, RN, BSN 816-861-4700 ext 57456 april.higbee@va.gov

Locations
United States, Missouri
Department of Veterans Affairs Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact: April D. Higbee, R.N., B.S.N.    816-861-4700 ext 7456    april.higbee@va.gov   
Principal Investigator: Prateek Sharma, MD         
United Kingdom
Queen Medical Center Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Sarmed S Sami, MRCP    01158231039    sarmed.sami@nottingham.ac.uk   
Principal Investigator: Krish Raghunath         
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Prateek Sharma, M.D. VA Office of Research and Development

Publications:

Responsible Party: PRATEEK SHARMA, Principal Investigator,, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT02081404     History of Changes
Other Study ID Numbers: 3155105
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants individual participant data collected in the study will be available to other researchers upon request. Participants will be identified by participant number, age, race and gender. This information will be available at the end of the study and may be requested via email to april.higbee@va.gov.

Keywords provided by PRATEEK SHARMA, Midwest Biomedical Research Foundation:
Non-erosive Reflux Disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action