CClinicalTrials.gg
Not yet recruitingNCT06897540Updated Mar 27, 2025

Barrett's Esophagus in Patients with GERD

An interventional study of Upper endoscopy in Barrett Esophagus, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Assiut University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Barrett Esophagus

Browse trials for

03

In context

Barrett Esophagus

310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.

This study's planned enrollment of 70 is above the median of 62 across 186 interventional studies indexed under Barrett Esophagus.

Browse Barrett Esophagus studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Other
    Patients with GERD

    Screening for Barrett's esophagus in patients with GERD by upper endoscopy

    Device: Upper endoscopy

Interventions

  • DeviceUpper endoscopy

    View mucosa of esophagus with upper endoscope

06

What researchers measure

Primary outcomes

  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.

    Time frame: Assessment of patients with GERD take about 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Only patients who will be discovered having Barrett's esophagus will their IPD ba shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06897540
Lead sponsor
Assiut University
Responsible party
Nervana Nasrat Habib Abd ElMalak (Resident doctor at Assiut University Hospitals, Assiut University) — Principal investigator
First posted
Mar 27, 2025
Start date
Apr 1, 2025 (estimated)
Primary completion
Mar 31, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Mar 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion