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Barrett EsophagusNCT06897540

Barrett's Esophagus in Patients with GERD

A study testing Upper endoscopy in people with Barrett Esophagus, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

To assess the prevalence and characteristics of BE in patients suffering of chronic GERD symptoms Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Barrett Esophagus
What is being tested?
Upper endoscopy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
1 Apr 2025to 1 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults diagnosed with GERD based on clinical symptoms and/or 24-hour pH monitoring or esophageal manometry.
  • Patients willing to undergo endoscopic examination
  • Exclusion criteria: Patients with a history of esophageal cancer.
  • Patients with other esophageal diseases, such as eosinophilic esophagitis, infections, or motility disorders.
  • Patients who are unable to consent or participate in the study

Who cannot join

None listed.

About this study

Official title: Screening for Barrett's Esophagus in Patients with Gastroesophageal Reflux Disease: Hospital Based Study

To assess the prevalence and characteristics of BE in patients suffering of chronic GERD symptoms

Read the detailed description

Barrett's esophagus (BE) is a metaplastic change of the lining of the esophagus with replacement of the normal squamous epithelium with columnar epithelium containing goblet cells. It is the most severe histological consequence of chronic gastroesophageal reflux and predisposes to the development of adenocarcinoma of the esophagus (Spechler SJ et al., 2001).

BE develops when metaplastic columnar mucosa replaces the normal esophageal squamous epithelium of the esophagus in response to damage caused by gastroesophageal reflux . The columnar-lined esophagus contains a mosaic of 3 different cell types: gastric fundic type epithelium, junctional cardiac epithelium, and specialized columnar epithelium with intestinal type goblet cells. Most professional guidelines from around the world agree that a diagnosis of BE requires the presence of Intestinal Metaplasia (IM) because of an increased risk of Esophageal Adenocarcinoma (EAC )associated with IM, although guidelines from the British Society of Gastroenterology and the Asia Pacific region do not require this (Shaheen NJ et al., 2022).

The poor prognosis of EAC has focused interest on BE. Identification of BE with treatment of dysplasia is important to prevent invasive cancer. On the other hand, gastroesophageal reflux disease (GERD) has been associated with an increased risk of BE. Despite recommendations against population-based screening, the majority of guidelines recommend considering screening of chronic GERD patients. However, 50% of EAC patients report no previous GERD (Marques de Sá I et al., 2020).

Current guidelines for the diagnosis and treatment of GERD state that empiric therapy should be given to patients with typical heartburn, and it is recommended that patients with chronic GERD symptoms undergo upper endoscopy (Sampliner R et al., 2005).

.The columnar metaplasia in BE causes no symptoms. Thus, patients are seen initially for symptoms of the associated GERD, such as heartburn and regurgitation. Endoscopically obvious BE can be seen in approximately 10% of patients who have endoscopic examinations for symptoms of GERD. However, approximately 25% of patients have no esophageal symptoms (Winters C Jr et al., 1987).

BE is usually discovered during endoscopic examination of middle-aged and older adults whose mean age at the time of diagnosis is approximately 55 years (Spechler SJ et al., 1996).

BE is best described by using the validated Prague criteria that includes both the circumferential and maximal extent of the columnar epithelium in the esophagus and the location of the proximal margin of the gastric folds and the diaphragmatic hiatus (Shaheen NJ et al., 2022). BE is associated with several risk factors. These include chronic reflux symptoms (defined as weekly symptoms for 5 or more years), male sex, age greater than 50 years, smoking, white race, central obesity, and family history. The prevalence in those with GERD and 1 additional risk factor was, however, substantially higher than GERD alone (12.2%). In addition, a positive linear relationship was also shown between the number of risk factors and BE prevalence, with each additional risk factor increasing the prevalence of BE by 1.2% (Shaheen NJ et al., 2022).

Being tested
Upper endoscopy
Medical subject headings
Barrett Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upper endoscopyDevice

    View mucosa of esophagus with upper endoscope

Study groups in NCT06897540
Study groupRoleWhat they receive
Patients with GERDOtherScreening for Barrett's esophagus in patients with GERD by upper endoscopy
Receives: Device: Upper endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the prevalence and characteristics of BE in patients suffering of chronic GERD symptoms.

    To assess the prevalence and characteristics of BE in patients suffering of chronic GERD symptoms.

    To evaluate demographic and clinical risk factors associated with BE in GERD patients.

    To assess the clinical features of GERD in patients who develop BE. To investigate the diagnostic methods used to detect BE in clinical settings. To assess the relationship between chronicity of GERD and development of BE.

    Measured: Assessment of patients with GERD take about 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2025
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06897540
Sponsor's protocol ID
Barrett's Esophagus
Status last verified
Mar 2025
First submitted
17 Mar 2025
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only patients who will be discovered having Barrett's esophagus will their IPD ba shared

Questions about this trial

What is this clinical trial studying?

A study testing Upper endoscopy in people with Barrett Esophagus, run by Assiut University.

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 5 inclusion and 0 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: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

To assess the prevalence and characteristics of BE in patients suffering of chronic GERD symptoms. (time frame: Assessment of patients with GERD take about 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Mar 2025.

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