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

NCT07510984 | Recruiting

• 2 other identifiers: SYM-HGM-01DRKS00039148
• Study Type: observational
• Target: 721
• Locations: 1 country
• Sites: 1

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.

Conditions

Heterotopic Gastric Mucosa of the Proximal Esophagus; Gastric Inlet Patches; Dysphagia; Dyspepsia

Keywords

Cervical Esophagus; Proximal Esophagus; Upper Endoscopy; Oropharyngeal Dysphagia; Eophageal Dysphagia; Sidney Swallowing Questionnaire; EAT-10; MDADI; GSRS; QOLRAD; Narrow Band Imaging; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Dysphagia Symptom Burdon (EAT-10 und SSQ)

  Dysphagia symptom burden is assessed using two patient-reported questionnaires completed prior to medically indicated gastroscopy: (1) the Sydney Swallow Questionnaire (SSQ/SSQ-G) and (2) the Eating Assessment Tool-10 (EAT-10). The SSQ total score ranges from 0 to 1700 (higher scores indicate worse swallowing-related symptoms); for descriptive/binary analyses, an SSQ-G total score \>234 is considered outside the normative range (pathological). The EAT-10 total score ranges from 0 to 40 (10 items scored 0-4; higher scores indicate greater dysphagia burden); an EAT-10 total score ≥3 is considered abnormal (indicative of dysphagia). Comparative analyses will be performed between participants with endoscopically detected heterotopic gastric mucosa (HGM) and participants without HGM.

  Baseline (prior to gastroscopy; single assessment at enrollment)

Secondary Outcomes (3)

• HGM & Dyspepsia (GSRS)

  Baseline (prior to gastroscopy; single assessment at enrollment)

• Type of Dysphagia (Oropharyngeal vs Esophageal)

  Baseline (prior to gastroscopy; single assessment at enrollment)

• Health-Related Quality of Life (HRQoL)

  Baseline (prior to gastroscopy; single assessment at enrollment)

Study Arms (2)

HGM present

Participants with endoscopic evidence of heterotrophic gastric mucosa

No HGM

Participants without endoscopic evidence of heterotrophic gastric mucosa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) undergoing clinically indicated upper gastrointestinal endoscopy (gastroscopy) at a single center will be consecutively screened and invited to participate over a 12-month period. After informed consent, participants complete symptom and health-related quality-of-life questionnaires prior to endoscopy. During routine gastroscopy, the presence or absence of heterotopic gastric mucosa (HGM) in the proximal esophagus is assessed based on endoscopic appearance (and histology from routine care if available). Participants are grouped as HGM present vs no HGM for comparative analyses.

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

Sponsors & Collaborators

• Knappschaft Kliniken GmbH: lead

Study Sites (1)

Knappschaftskrankenhaus Bottrop

Bottrop, North Rhine-Westphalia, 46240, Germany

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Dyspepsia

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Felix Horstmann, MD

CONTACT

02041151500; felix.horstmann@knappschaft-kliniken.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident Physician in the Department of Gastroenterology and Research Associate

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 6, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): March 24, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)