NCT07510984 Symptoms and Quality of Life in Patients With Heterotopic Gastric Mucosa (HGM)
| NCT ID | NCT07510984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Knappschaft Kliniken GmbH |
| Condition | Heterotopic Gastric Mucosa of the Proximal Esophagus |
| Study Type | OBSERVATIONAL |
| Enrollment | 721 participants |
| Start Date | 2026-03-24 |
| Primary Completion | 2027-03-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 721 participants in total. It began in 2026-03-24 with a primary completion date of 2027-03-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07510984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heterotopic Gastric Mucosa of the Proximal Esophagus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07510984 currently recruiting?
Yes, NCT07510984 is actively recruiting participants. Contact the research team at felix.horstmann@knappschaft-kliniken.de for enrollment information.
Where is the NCT07510984 trial being conducted?
This trial is being conducted at Bottrop, Germany.
Who is sponsoring the NCT07510984 clinical trial?
NCT07510984 is sponsored by Knappschaft Kliniken GmbH. The trial plans to enroll 721 participants.