Prevalence and Characterization of Dysphagia and Dyspepsia Symptoms and Assessment of Quality of Life in Heterotopic Gastric Mucosa (HGM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 721
- 试验地点
- 1
- 主要终点
- Dysphagia Symptom Burdon
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HGM present
Participants with endoscopic evidence of heterotrophic gastric mucosa
No HGM
Participants without endoscopic evidence of heterotrophic gastric mucosa
结局指标
主要结局
Dysphagia Symptom Burdon
时间窗: Baseline (prior to gastroscopy; single assessment at enrollment)
Dysphagia symptom burden assessed by a standardized patient-reported questionnaire completed prior to medically indicated gastroscopy; comparison between participants with endoscopically detected HGM vs participants without HGM.
Dysphagia Symptom Burdon (EAT-10 und SSQ)
时间窗: Baseline (prior to gastroscopy; single assessment at enrollment)
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.
次要结局
- HGM & Dyspepsia(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))
- HGM & Dyspepsia (GSRS)(Baseline (prior to gastroscopy; single assessment at enrollment))
研究者
Felix Horstmann
MD, Resident Physician in the Department of Gastroenterology and Research Associate
Knappschaft Kliniken GmbH