Symptoms and quality of life in people with gastric inlet patches
Prevalence and Characterization of Dysphagia and Dyspepsia Symptoms and Assessment of Quality of Life in Heterotopic Gastric Mucosa (HGM)
This study will see if adults having a medically indicated gastroscopy who have heterotopic gastric mucosa (gastric inlet patches) are more likely to have swallowing problems, indigestion, or lower quality of life than those without it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 721 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Knappschaft Kliniken GmbH Academic / other |
| Locations | 1 site (Bottrop, North Rhine-Westphalia) |
| Trial ID | NCT07510984 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational, single-center study enrolling adults undergoing clinically indicated gastroscopy. Participants complete pseudonymized questionnaires about oropharyngeal and esophageal dysphagia, dyspepsia symptoms, and health-related quality of life before their procedure. Endoscopic findings will classify participants as having endoscopically confirmed heterotopic gastric mucosa (HGM) or not, and the study will compare symptom patterns and quality-of-life measures between these groups. An exploratory analysis will examine symptom differences by histologic subtype when routine histology is available.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for an upper gastrointestinal endoscopy who can give informed consent and complete the pre-procedure questionnaires are ideal candidates.
Not a fit: People with previously known HGM, prior treated dysphagia, inability to undergo careful proximal esophageal inspection, or inability to complete questionnaires are unlikely to benefit from participation.
Why it matters
Potential benefit: If a clear link between HGM and symptoms is found, clinicians may better recognize a treatable cause of dysphagia or dyspepsia and target follow-up or therapy.
How similar studies have performed: Retrospective reports have suggested associations between HGM and symptoms, but prospective data and formal quality-of-life comparisons are limited, so this question remains only partially explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bottrop, North Rhine-Westphalia
- Knappschaftskrankenhaus Bottrop — Bottrop, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Study coordinator: Felix Horstmann, MD
- Email: felix.horstmann@knappschaft-kliniken.de
- Phone: 02041151500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.