An observational study in Heterotopic Gastric Mucosa of the Proximal Esophagus, Gastric Inlet Patches and Dysphagia, sponsored by Knappschaft Kliniken GmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Knappschaft Kliniken GmbH · Observational
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:
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.
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 721 is above the median of 84 across 249 observational studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →This is the only study on the registry with Knappschaft Kliniken GmbH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with endoscopic evidence of heterotrophic gastric mucosa
Participants without endoscopic evidence of heterotrophic gastric mucosa
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)
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)
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)
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)
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 12 months after the start.
Of 117 non-industry observational studies under Deglutition Disorders, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 52. This study's planned 12 months is below that.
Counting every sponsor, half of 120 studies reached it within 25 months; a quarter within 11 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.