Barrett EsophagusNCT06897540
Barrett's Esophagus in Patients with GERD
A study testing Upper endoscopy in people with Barrett Esophagus, run by Assiut University.
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).
- Conditions
- Barrett Esophagus
- 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 group | Role | What they receive |
|---|---|---|
| Patients with GERD | Other | Screening 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.
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.
- First posted27 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nervana Nasrat Habib Abd ElMalak, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Barrett's Esophagus in Patients with Gastroesophageal Reflux Disease: Hospital Based Study
- ClinicalTrials.gov ID
- NCT06897540
- Acronym / sponsor ID
- Barrett's Esophagus
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Mar 2025 (actual)
- 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.
To assess the prevalence and characteristics of BE in patients suffering of chronic GERD symptoms
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).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with GERD | Other | Device: Upper endoscopyScreening for Barrett's esophagus in patients with GERD by upper endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper endoscopyView mucosa of esophagus with upper endoscope | Device | Patients with GERD |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No. Only patients who will be discovered having Barrett's esophagus will their IPD ba shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
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.