Symptoms and Quality of Life in Patients With Heterotopic Gastric Mucosa (HGM)
Recruiting now
Conditions studied: Heterotopic Gastric Mucosa of the Proximal Esophagus, Gastric Inlet Patches, Dysphagia, Dyspepsia
In brief
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.
Key facts
- Study ID
- NCT07510984
- Run by
- Knappschaft Kliniken GmbH
- People needed
- 721
- Starts
- 2026-03-24
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Knappschaftskrankenhaus Bottrop — Bottrop, North Rhine-Westphalia, Germany (enrolling)
Full record on ClinicalTrials.gov
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