NCT00576992

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,177

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

14.3 years

First QC Date

December 18, 2007

Last Update Submit

May 24, 2017

Conditions

Barrett EsophagusGastroesophageal Reflux

Keywords

Barrett's EsophagusDemographicsQuestionnaireHeartburn

Outcome Measures

Primary Outcomes (1)

  • Determine the prevalence of gastric and esophageal disease in patients presenting with the complaints of dyspepsia, GERD, or extraesophageal symptoms

    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

    1 year

Study Arms (1)

GI observation

Patients presenting for an upper endoscopy procedure with gastrointestinal symptoms or complaints.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is a Veteran population presenting to a VA Hospital upper endoscopy unit

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

Location

Related Publications (12)

  • 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.

    PMID: 10780569BACKGROUND

  • Winters 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.

    PMID: 3781178BACKGROUND

  • Johnston 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.

    PMID: 8759651BACKGROUND

  • Hirota 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.

    PMID: 9922307BACKGROUND

  • Knill-Jones RP. Geographical differences in the prevalence of dyspepsia. Scand J Gastroenterol Suppl. 1991;182:17-24. doi: 10.3109/00365529109109532.

    PMID: 1896825BACKGROUND

  • Jones R, Lydeard S. Dyspepsia in the community: a follow-up study. Br J Clin Pract. 1992 Summer;46(2):95-7.

    PMID: 1457318BACKGROUND

  • Voutilainen 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.

    PMID: 10671769BACKGROUND

  • de 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.

    PMID: 4463131BACKGROUND

  • de 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.

    PMID: 4852636BACKGROUND

  • Flook 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.

    PMID: 4041712BACKGROUND

  • Earlam 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.

    PMID: 3965370BACKGROUND

  • Goldman 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.

    PMID: 6045993BACKGROUND

MeSH Terms

Conditions

Barrett EsophagusGastroesophageal RefluxHeartburn

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesEsophageal Motility DisordersDeglutition DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prateek Sharma, MD

    Department of Veterans Affairs Medical Center of Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

January 1, 2003

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)