Barrett EsophagusNCT00576992
Demographics and Findings of Upper Endoscopy Patients
An observational study of Barrett Esophagus and Gastroesophageal Reflux, run by Midwest Biomedical Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the demographics, patients symptoms, and findings during endoscopy. Patients presenting for an endoscopy procedure to the KCVA GI endoscopy suite, will be asked to fill out questionnaires pertaining to their symptoms and indications for the procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Gastroesophageal Reflux
- How many people
- 1,177 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is a Veteran population presenting to a VA Hospital upper endoscopy unit
Who may be able to join
- Patients who present to the KCVA GI endoscopy unit with symptoms of reflux,upper abdominal pain, anemia (patients referred by their primary care physicians with a diagnosis of low hemoglobin (< 10 G/DL, and or dyspepsia
Who cannot join
- Weight loss (Weight loss of > 10% of their mean body weight over last 6 months)
- Dysphagia
- Gastrointestinal bleeding
- Gastrointestinal malignancy
- Recent EGD (in the past 5 years)
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Veterans Affairs Medical Center
Kansas City, Missouri, 64128
About this study
Official title: A Clinical Study of Demographics and Findings During Endoscopy in Patients With Abdominal Pain, Dyspepsia, GERD, and Associated Symptoms
The purpose of this study is to evaluate the demographics, patients symptoms, and findings during endoscopy. Patients presenting for an endoscopy procedure to the KCVA GI endoscopy suite, will be asked to fill out questionnaires pertaining to their symptoms and indications for the procedure. This will be done before their procedure during the interview period preceding endoscopy. The patient's answers to this questionnaire will aid us in determining the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms and to also determine whether the presence of any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above endoscopic diagnoses.
Read the detailed description
Barrett's esophagus is a pre-malignant condition associated with adenocarcinoma of the lower esophagus, and is found in 10-15% of patients with Gastroesophageal Reflux Disease (GERD). In prospective studies of patients undergoing endoscopy for reflux symptoms, the prevalence of long segments of Barrett's Esophagus (3cm or greater) is reported to be 3% and that of short segment Barrett's Esophagus (less than 3cm), to be approximately 7-8%. Early diagnosis with surveillance is considered the optimal approach in patients with Barrett's, given the poor survival of advanced adenocarcinoma of the esophagus. However, classic symptoms of GERD may be diminished in some patients with Barrett's esophagus, possibly leading to a lower incidence of endoscopy with early diagnosis.
Extraesophageal manifestations of GERD include hoarseness, wheezing, and globus sensation. Dyspepsia is defined as pain or discomfort centered in the upper abdomen. Some reports have quantified the incidence of dyspepsia as occurring in up to 40% of adults over a six-month period. The differential diagnosis of dyspepsia includes gastric or duodenal ulcer, gastroesophageal reflux disease, gastric cancer, and non-ulcer dyspepsia. The incidence of peptic ulcer disease appears to be decreasing in our population, largely due to the lower prevalence of Helicobacter pylori infection among the population. Thus, esophageal lesions are responsible for an increasing number of dyspeptic patients.
Controversies exist as to the proper management of patients presenting with dyspepsia. Empiric acid-suppression therapy is often the first step in the management of dyspeptic patients. Many physicians have adopted a test-and-treat strategy for Helicobacter pylori infection. Finally, upper endoscopy may be performed. This test is considered the gold standard for the diagnosis of esophageal and gastroduodenal lesions. The initial evaluation of dyspeptic patients may be modified by other factors in their presentation, i.e. age greater than 50 or the presence of alarm symptoms (weight loss, dysphagia, evidence of gastrointestinal bleeding, anemia, or previous gastric surgery).
A distinction between the various causes of dyspepsia is important to establish in view of the significant differences in treatment strategies. Several previously reported studies have established a correlation between dyspepsia, with or without peptic ulcer disease, and erosive esophagitis. These studies were limited by a high degree of patient selection and narrow patient populations. Although the prevalence of erosive esophagitis and Barrett's Esophagus has been reported in patients with typical GERD symptoms, i.e. heartburn and regurgitation, the exact prevalence in patients with atypical symptoms of GERD (cough, asthma, wheezing, dysphagia), abdominal pain and dyspepsia is not readily known, especially in a VA population. Given that these esophageal diseases affect mainly older Caucasian males, studying the prevalence of these diseases in a VA population would be of extreme significance and importance.
- Conditions
- Barrett Esophagus, Gastroesophageal Reflux
- Keywords
- Barrett's Esophagus, Demographics, Questionnaire, Heartburn
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GI observation | Patients presenting for an upper endoscopy procedure with gastrointestinal symptoms or complaints. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms
Measured: 1 year
Secondary outcomes (1)
Determine whether the presence of any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above endoscopic diagnoses
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startJan 2003
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Recruitment not being met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Biomedical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas City Veteran Affairs Medical Center
- Responsible party
- Principal investigator, PRATEEK SHARMA, Midwest Biomedical Research
- Investigators
- Prateek Sharma, MD, Principal investigator, Department of Veterans Affairs Medical Center of Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576992
- Sponsor's protocol ID
- PS0014
- Status last verified
- May 2017
- First submitted
- 18 Dec 2007
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sonnenberg A, El-Serag HB. Clinical epidemiology and natural history of gastroesophageal reflux disease. Yale J Biol Med. 1999 Mar-Jun;72(2-3):81-92.
PubMed 10780569Winters C Jr, Spurling TJ, Chobanian SJ, Curtis DJ, Esposito RL, Hacker JF 3rd, Johnson DA, Cruess DF, Cotelingam JD, Gurney MS, et al. Barrett's esophagus. A prevalent, occult complication of gastroesophageal reflux disease. Gastroenterology. 1987 Jan;92(1):118-24.
PubMed 3781178Johnston MH, Hammond AS, Laskin W, Jones DM. The prevalence and clinical characteristics of short segments of specialized intestinal metaplasia in the distal esophagus on routine endoscopy. Am J Gastroenterol. 1996 Aug;91(8):1507-11.
PubMed 8759651Hirota WK, Loughney TM, Lazas DJ, Maydonovitch CL, Rholl V, Wong RK. Specialized intestinal metaplasia, dysplasia, and cancer of the esophagus and esophagogastric junction: prevalence and clinical data. Gastroenterology. 1999 Feb;116(2):277-85. doi: 10.1016/s0016-5085(99)70123-x.
PubMed 9922307Knill-Jones RP. Geographical differences in the prevalence of dyspepsia. Scand J Gastroenterol Suppl. 1991;182:17-24. doi: 10.3109/00365529109109532.
PubMed 1896825Jones R, Lydeard S. Dyspepsia in the community: a follow-up study. Br J Clin Pract. 1992 Summer;46(2):95-7.
PubMed 1457318Voutilainen M, Sipponen P, Mecklin JP, Juhola M, Farkkila M. Gastroesophageal reflux disease: prevalence, clinical, endoscopic and histopathological findings in 1,128 consecutive patients referred for endoscopy due to dyspeptic and reflux symptoms. Digestion. 2000;61(1):6-13. doi: 10.1159/000007730.
PubMed 10671769de Moraes-Filho JP, Zaterka S, Pinotti HW, Bettarello A. Esophagitis and duodenal ulcer. Digestion. 1974;11(5-6):338-46. doi: 10.1159/000197601. No abstract available.
PubMed 4463131de Moraes-Filho JP. Lack of specificity of the acid perfusion test in duodenal ulcer patients. Am J Dig Dis. 1974 Sep;19(9):785-90. doi: 10.1007/BF01071936. No abstract available.
PubMed 4852636Flook D, Stoddard CJ. Gastro-oesophageal reflux and oesophagitis before and after vagotomy for duodenal ulcer. Br J Surg. 1985 Oct;72(10):804-7. doi: 10.1002/bjs.1800721010.
PubMed 4041712Earlam RJ, Amerigo J, Kakavoulis T, Pollock DJ. Histological appearances of oesophagus, antrum and duodenum and their correlation with symptoms in patients with a duodenal ulcer. Gut. 1985 Jan;26(1):95-100. doi: 10.1136/gut.26.1.95.
PubMed 3965370Goldman MS Jr, Rasch JR, Wiltsie DS, Finkel M. The incidence of esophagitis in peptic ulcer disease. Am J Dig Dis. 1967 Oct;12(10):994-9. doi: 10.1007/BF02233258. No abstract available.
PubMed 6045993
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Demographics and Findings During Endoscopy in Patients With Abdominal Pain, Dyspepsia, GERD, and Associated Symptoms
- ClinicalTrials.gov ID
- NCT00576992
- Acronym / sponsor ID
- PS0014
- Conditions
- Barrett Esophagus, Gastroesophageal Reflux
- Keywords
- Barrett's Esophagus, Demographics, Questionnaire, Heartburn
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment not being met
- Enrolment
- 1,177 participants (actual)
- Lead sponsor
- Midwest Biomedical ResearchUniversity, hospital or other
- Collaborators
- Kansas City Veteran Affairs Medical Center
- Study start
- Jan 2003
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the demographics, patients symptoms, and findings during endoscopy. Patients presenting for an endoscopy procedure to the KCVA GI endoscopy suite, will be asked to fill out questionnaires pertaining to their symptoms and indications for the procedure. This will be done before their procedure during the interview period preceding endoscopy. The patient's answers to this questionnaire will aid us in determining the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms and to also determine whether the presence of any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above endoscopic diagnoses.
Detailed description
Barrett's esophagus is a pre-malignant condition associated with adenocarcinoma of the lower esophagus, and is found in 10-15% of patients with Gastroesophageal Reflux Disease (GERD). In prospective studies of patients undergoing endoscopy for reflux symptoms, the prevalence of long segments of Barrett's Esophagus (3cm or greater) is reported to be 3% and that of short segment Barrett's Esophagus (less than 3cm), to be approximately 7-8%. Early diagnosis with surveillance is considered the optimal approach in patients with Barrett's, given the poor survival of advanced adenocarcinoma of the esophagus. However, classic symptoms of GERD may be diminished in some patients with Barrett's esophagus, possibly leading to a lower incidence of endoscopy with early diagnosis.
Extraesophageal manifestations of GERD include hoarseness, wheezing, and globus sensation. Dyspepsia is defined as pain or discomfort centered in the upper abdomen. Some reports have quantified the incidence of dyspepsia as occurring in up to 40% of adults over a six-month period. The differential diagnosis of dyspepsia includes gastric or duodenal ulcer, gastroesophageal reflux disease, gastric cancer, and non-ulcer dyspepsia. The incidence of peptic ulcer disease appears to be decreasing in our population, largely due to the lower prevalence of Helicobacter pylori infection among the population. Thus, esophageal lesions are responsible for an increasing number of dyspeptic patients.
Controversies exist as to the proper management of patients presenting with dyspepsia. Empiric acid-suppression therapy is often the first step in the management of dyspeptic patients. Many physicians have adopted a test-and-treat strategy for Helicobacter pylori infection. Finally, upper endoscopy may be performed. This test is considered the gold standard for the diagnosis of esophageal and gastroduodenal lesions. The initial evaluation of dyspeptic patients may be modified by other factors in their presentation, i.e. age greater than 50 or the presence of alarm symptoms (weight loss, dysphagia, evidence of gastrointestinal bleeding, anemia, or previous gastric surgery).
A distinction between the various causes of dyspepsia is important to establish in view of the significant differences in treatment strategies. Several previously reported studies have established a correlation between dyspepsia, with or without peptic ulcer disease, and erosive esophagitis. These studies were limited by a high degree of patient selection and narrow patient populations. Although the prevalence of erosive esophagitis and Barrett's Esophagus has been reported in patients with typical GERD symptoms, i.e. heartburn and regurgitation, the exact prevalence in patients with atypical symptoms of GERD (cough, asthma, wheezing, dysphagia), abdominal pain and dyspepsia is not readily known, especially in a VA population. Given that these esophageal diseases affect mainly older Caucasian males, studying the prevalence of these diseases in a VA population would be of extreme significance and importance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GI observation | – | –Patients presenting for an upper endoscopy procedure with gastrointestinal symptoms or complaints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is a Veteran population presenting to a VA Hospital upper endoscopy unit
Key inclusion criteria (1 listed)
- Patients who present to the KCVA GI endoscopy unit with symptoms of reflux,upper abdominal pain, anemia (patients referred by their primary care physicians with a diagnosis of low hemoglobin (< 10 G/DL, and or dyspepsia
Key exclusion criteria (5 listed)
- Weight loss (Weight loss of > 10% of their mean body weight over last 6 months)
- Dysphagia
- Gastrointestinal bleeding
- Gastrointestinal malignancy
- Recent EGD (in the past 5 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms
Time frame: 1 year
1 secondary outcome
Determine whether the presence of any factors (hiatal hernia, NSAID use, age, race, gender, etc.) contribute to the above endoscopic diagnoses
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Recruitment not being met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Background: PubMed 10780569Sonnenberg A, El-Serag HB. Clinical epidemiology and natural history of gastroesophageal reflux disease. Yale J Biol Med. 1999 Mar-Jun;72(2-3):81-92.
- Background: PubMed 3781178Winters C Jr, Spurling TJ, Chobanian SJ, Curtis DJ, Esposito RL, Hacker JF 3rd, Johnson DA, Cruess DF, Cotelingam JD, Gurney MS, et al. Barrett's esophagus. A prevalent, occult complication of gastroesophageal reflux disease. Gastroenterology. 1987 Jan;92(1):118-24.
- Background: PubMed 8759651Johnston MH, Hammond AS, Laskin W, Jones DM. The prevalence and clinical characteristics of short segments of specialized intestinal metaplasia in the distal esophagus on routine endoscopy. Am J Gastroenterol. 1996 Aug;91(8):1507-11.
- Background: PubMed 9922307Hirota WK, Loughney TM, Lazas DJ, Maydonovitch CL, Rholl V, Wong RK. Specialized intestinal metaplasia, dysplasia, and cancer of the esophagus and esophagogastric junction: prevalence and clinical data. Gastroenterology. 1999 Feb;116(2):277-85. doi: 10.1016/s0016-5085(99)70123-x.
- Background: PubMed 1896825Knill-Jones RP. Geographical differences in the prevalence of dyspepsia. Scand J Gastroenterol Suppl. 1991;182:17-24. doi: 10.3109/00365529109109532.
- Background: PubMed 1457318Jones R, Lydeard S. Dyspepsia in the community: a follow-up study. Br J Clin Pract. 1992 Summer;46(2):95-7.
- Background: PubMed 10671769Voutilainen M, Sipponen P, Mecklin JP, Juhola M, Farkkila M. Gastroesophageal reflux disease: prevalence, clinical, endoscopic and histopathological findings in 1,128 consecutive patients referred for endoscopy due to dyspeptic and reflux symptoms. Digestion. 2000;61(1):6-13. doi: 10.1159/000007730.
- Background: PubMed 4463131de Moraes-Filho JP, Zaterka S, Pinotti HW, Bettarello A. Esophagitis and duodenal ulcer. Digestion. 1974;11(5-6):338-46. doi: 10.1159/000197601. No abstract available.
- Background: PubMed 4852636de Moraes-Filho JP. Lack of specificity of the acid perfusion test in duodenal ulcer patients. Am J Dig Dis. 1974 Sep;19(9):785-90. doi: 10.1007/BF01071936. No abstract available.
- Background: PubMed 4041712Flook D, Stoddard CJ. Gastro-oesophageal reflux and oesophagitis before and after vagotomy for duodenal ulcer. Br J Surg. 1985 Oct;72(10):804-7. doi: 10.1002/bjs.1800721010.
- Background: PubMed 3965370Earlam RJ, Amerigo J, Kakavoulis T, Pollock DJ. Histological appearances of oesophagus, antrum and duodenum and their correlation with symptoms in patients with a duodenal ulcer. Gut. 1985 Jan;26(1):95-100. doi: 10.1136/gut.26.1.95.
- Background: PubMed 6045993Goldman MS Jr, Rasch JR, Wiltsie DS, Finkel M. The incidence of esophagitis in peptic ulcer disease. Am J Dig Dis. 1967 Oct;12(10):994-9. doi: 10.1007/BF02233258. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prateek Sharma, MD principal investigator
Department of Veterans Affairs Medical Center of Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus and Gastroesophageal Reflux, run by Midwest Biomedical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment not being met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00576992, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.