Symptoms and Quality of Life in Patients With Heterotopic Gastric Mucosa (HGM) (NCT07510984) | Clinical Trial Compass
RecruitingNot Applicable
Symptoms and Quality of Life in Patients With Heterotopic Gastric Mucosa (HGM)
Germany721 participantsStarted 2026-03-24
Plain-language summary
The goal of this observational study is to learn whether heterotopic gastric mucosa (HGM) in the upper esophagus is associated with swallowing difficulties (dysphagia) in adults undergoing a medically indicated gastroscopy. The main questions it aims to answer are:
* Is the presence of HGM associated with dysphagia?
* Is the presence of HGM associated with dyspepsia and reduced health-related quality of life? Among participants reporting dysphagia, what is the distribution of oropharyngeal versus esophageal dysphagia, and is this related to the presence of HGM? If there is a comparison group: Researchers will compare participants with endoscopically confirmed HGM to participants without HGM to determine whether dysphagia, dyspepsia symptoms, and quality-of-life measures differ between groups.
Participants will:
Complete pseudonymised questionnaires about dysphagia, dyspepsia symptoms, and quality of life before the gastroscopy.
Undergo the medically indicated gastroscopy as planned; the endoscopist will assess whether HGM is present based on the endoscopic appearance, and routine endoscopy findings will be documented.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Planned upper gastrointestinal endoscopy (gastroscopy) for clinical reasons (any indication)
* Age ≥ 18 years
* Written informed consent
* Ability to complete the study questionnaires prior to endoscopy
Exclusion Criteria:
* Previously known heterotopic gastric mucosa (HGM)
* Previously diagnosed dysphagia with prior therapeutic intervention (including pre-established diet modification, partial oral/enteral nutrition, steroid therapy, botulinum toxin injection, etc.)
* Mechanical ventilation
* Presence of a tracheostomy
* Inadequate endoscopic assessability of the proximal esophagus, including:
* General condition insufficient for careful endoscopic inspection (investigator's judgement)
* Increased risk of aspiration
* Inadequate visibility during the procedure (e.g., bleeding, food residue)
* Complications preventing careful inspection of the proximal esophagus
* History of surgery involving the pharynx or esophagus
* Relevant severe neurological disorder (e.g., ALS, stroke)
* Severe dementia
* Severe depressive disorder
* Lack of cooperation / inability to comply with study procedures
* Planned PEG placement
* Emergency endoscopy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dysphagia Symptom Burdon (EAT-10 und SSQ)
Timeframe: Baseline (prior to gastroscopy; single assessment at enrollment)