RecruitingNCT07510984

Symptoms and Quality of Life in Patients With Heterotopic Gastric Mucosa (HGM)

Prevalence and Characterization of Dysphagia and Dyspepsia Symptoms and Assessment of Quality of Life in Heterotopic Gastric Mucosa (HGM)


Sponsor

Knappschaft Kliniken GmbH

Enrollment

721 participants

Start Date

Mar 24, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria16

  • 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

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Locations(1)

Knappschaftskrankenhaus Bottrop

Bottrop, North Rhine-Westphalia, Germany

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NCT07510984


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