Actively Recruiting
Prevalence and Characterization of Dysphagia and Dyspepsia Symptoms and Assessment of Quality of Life in Heterotopic Gastric Mucosa (HGM)
Led by Knappschaft Kliniken GmbH · Updated on 2026-04-14
721
Participants Needed
1
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether heterotopic gastric mucosa (HGM), which are islands of stomach-like tissue in the upper esophagus, is linked to swallowing difficulties (dysphagia) in adults undergoing medically needed gastroscopy. The study also looks at connections between HGM and indigestion symptoms (dyspepsia) and their impact on quality of life. Participants with and without HGM will be compared to see if symptoms and quality-of-life measures differ between these groups. This is a prospective, observational study involving adults aged 18 and older who are scheduled for gastroscopy for any medical reason. Before the procedure, participants fill out questionnaires about dysphagia, dyspepsia, and quality of life. During the planned gastroscopy, doctors check for HGM without influencing the procedure. No extra procedures are required beyond the routine gastroscopy and any clinical tissue sampling. Participants complete detailed symptom and quality-of-life questionnaires before gastroscopy. The study collects data on swallowing difficulties, indigestion symptoms, and health-related quality of life using validated tools. The presence of HGM is recorded during routine endoscopy without revealing questionnaire answers to the doctor. Data will be analyzed to understand the relationship between HGM and symptoms. Total participation involves a single assessment before gastroscopy, with no additional follow-up required.
CONDITIONS
Brief Title
Symptoms and Quality of Life in Patients With Heterotopic Gastric Mucosa (HGM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned upper gastrointestinal endoscopy (gastroscopy) for clinical reasons (any indication)
- Age 18 years or older
- Written informed consent
- Ability to complete the study questionnaires before endoscopy
You will not qualify if you...
- Previously known heterotopic gastric mucosa (HGM)
- Previously diagnosed swallowing difficulties with prior treatment such as diet modification, nutrition support, steroid therapy, or botulinum toxin injection
- Mechanical ventilation
- Presence of a tracheostomy
- Inadequate endoscopic access or visibility of the proximal esophagus
- General condition insufficient for careful endoscopic inspection
- Increased risk of aspiration
- Complications preventing careful inspection of the proximal esophagus
- History of surgery involving the pharynx or esophagus
- Severe neurological disorders like ALS or stroke
- Severe dementia
- Severe depressive disorder
- Inability or unwillingness to comply with study procedures
- Planned PEG placement
- Emergency endoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and questionnaire completion prior to gastroscopy
Duration - Single day
Participants undergo routine upper gastrointestinal endoscopy to inspect the proximal esophagus for heterotopic gastric mucosa (HGM). No additional procedures beyond routine care are performed.
1 visit (in-person) for clinically indicated gastroscopy
Duration - Up to 12 months
Participants' symptoms and quality of life related to dysphagia and dyspepsia are assessed through questionnaires completed at baseline prior to endoscopy. Participants are observed based on routine clinical data and any histology available from routine care.
No additional study visits; data collected from routine care and questionnaires
Trial Site Locations
Total: 1 location
1
Knappschaftskrankenhaus Bottrop
Bottrop, North Rhine-Westphalia, Germany, 46240
Actively Recruiting
Research Team
F
Felix Horstmann, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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