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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKnappschaft Kliniken GmbH

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

721 Participants
are grouped into 2 trial groups
Group A: HGM present
Group B: No HGM

Trial outcomes

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.

Time frame
Baseline (prior to gastroscopy; single assessment at enrollment)

Secondary outcomes

1

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.

Time frame
Baseline (prior to gastroscopy; single assessment at enrollment)
2

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.

Time frame
Baseline (prior to gastroscopy; single assessment at enrollment)
3

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

Time frame
Baseline (prior to gastroscopy; single assessment at enrollment)

Other outcomes

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