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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia; Dysphagia; Heterotopic Gastric Mucosa of the Proximal Esophagus; Gastric Inlet Patches

Detailed Description

Heterotopic gastric mucosa (HGM) consists of islands of gastric-type mucosa located in the proximal esophagus, typically just below the upper esophageal sphincter. HGM is frequently detected incidentally during upper GI endoscopy, and its clinical relevance remains incompletely understood. Retrospective data suggest that HGM may be associated with symptoms such as dysphagia and dyspepsia; however, prospective data and information on health-related quality of life are limited.

This is a prospective, observational, single-center study conducted in adults (≥18 years) undergoing clinically indicated gastroscopy for any indication. The primary objective is to investigate the association between HGM and dysphagia. Secondary objectives are to evaluate associations between HGM and dyspepsia and impairment of quality of life, and to differentiate oropharyngeal versus esophageal dysphagia. An additional exploratory objective is to assess whether symptom patterns vary by histological subtype when histology is available from routine care.

After informed consent, participants complete paper-based, pseudonymised questionnaires prior to endoscopy (estimated completion time ~30-45 minutes). Oropharyngeal dysphagia is assessed using the Sydney Swallowing Questionnaire (SSQ, German version), and esophageal dysphagia using the Eating Assessment Tool-10 (EAT-10, German version). Dysphagia-related quality of life is assessed with the M.D. Anderson Dysphagia Inventory (MDADI, German validated version/D-ADI). Dyspepsia symptom burden and related quality of life are assessed using the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD). The endoscopist is blinded to questionnaire results. During routine gastroscopy, the proximal esophagus is carefully inspected (preferably using Narrow Band Imaging) and the presence or absence of HGM is documented; participants are assigned to HGM or control (no HGM) groups. No additional procedures are mandated by the study; routine endoscopy and any clinically indicated histology are recorded as available.

Data are collected and stored in pseudonymised form and analyzed statistically (planned recruitment period ~12 months). The anticipated total sample size is 731 participants.

• Study Type: Observational
• Enrollment (Estimated): 721

Contacts and Locations

• Study Contact: Name: Felix Horstmann, MD; Phone Number: 02041151500; Email: felix.horstmann@knappschaft-kliniken.de

Study Locations

• Germany
  • North Rhine-Westphalia
    • Bottrop, North Rhine-Westphalia, Germany, 46240
      • Recruiting
      • Knappschaftskrankenhaus Bottrop
      • Contact: Felix Horstmann, MD; Phone Number: +492041151501; Email: felix.horstmann@kjnappschft-kliniken.de
      • Contact: Thorsten Brechmann, Priv.-Doz. Dr.med, MD; Phone Number: +492041151500; Email: thorsten.brechmann@rub.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HGM present; Participants with endoscopic evidence of heterotrophic gastric mucosa
No HGM; Participants without endoscopic evidence of heterotrophic gastric mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HGM & Dyspepsia (GSRS)	Dyspepsia symptom burden assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a 15-item patient-reported questionnaire referring to symptoms during the past week. Items are rated on a 7-point Likert scale from 1 (no discomfort) to 7 (very severe discomfort); higher scores indicate worse symptoms. GSRS domain scores (mean of items within the domain) will be analyzed, focusing on the Indigestion and Abdominal Pain domains as dyspepsia-related measures. As there is no universally defined clinical cut-off for GSRS, a score ≥4 (at least moderate symptom severity) may be used for descriptive/binary analyses. Comparison between participants with endoscopically detected HGM vs participants without HGM.	Baseline (prior to gastroscopy; single assessment at enrollment)
Type of Dysphagia (Oropharyngeal vs Esophageal)	Classification of dysphagia phenotype as oropharyngeal versus esophageal based on participant-reported symptom patterns captured in the Sydney Swallow Questionnaire (SSQ/SSQ-G) and the Eating Assessment Tool-10 (EAT-10), completed prior to medically indicated gastroscopy. The distribution of dysphagia type (oropharyngeal vs esophageal) will be compared between participants with endoscopically detected heterotopic gastric mucosa (HGM) and participants without HGM. Abnormal dysphagia symptom burden is defined as SSQ-G total score >234 and/or EAT-10 total score ≥3.	Baseline (prior to gastroscopy; single assessment at enrollment)
Health-Related Quality of Life (HRQoL)	Health-related quality of life (HRQoL) is assessed using two disease-specific patient-reported questionnaires completed prior to medically indicated gastroscopy: (1) the German version of the M.D. Anderson Dysphagia Inventory (MDADI-D / A-ADI) to quantify swallowing-related quality of life, and (2) the German version of the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) to quantify reflux/dyspepsia-related quality of life. The MDADI-D/A-ADI composite score is linearly transformed to a scale of 20-100, with higher scores indicating better swallowing-related HRQoL; for descriptive/binary analyses, MDADI-D/A-ADI composite score <60 may be considered poor (moderate-to-severe impairment). QOLRAD items are rated on a 7-point Likert scale (1-7), with lower scores indicating worse HRQoL; domain scores (mean of items within each domain) and/or an overall mean score will be analyzed. As there is no universally established clinical cut-off for QOLRAD, a pragmatic threshold of QOL	Baseline (prior to gastroscopy; single assessment at enrollment)

Collaborators and Investigators

• Sponsor: Knappschaft Kliniken GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): March 24, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Narrow Band Imaging; Upper Endoscopy; GSRS; Oropharyngeal Dysphagia; QOLRAD; EAT-10; Cervical Esophagus; Proximal Esophagus; Eophageal Dysphagia; Sidney Swallowing Questionnaire; MDADI
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Deglutition Disorders; Dyspepsia
• Other Study ID Numbers: SYM-HGM-01; DRKS00039148 (Other Identifier: German Clinical Trail Register (DRKS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. Only aggregated results will be published; data access is restricted due to data protection requirements and the wording of the informed consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No