A Prospective Cohort Study on Endoscopic Features of Upper Gastrointestinal Tract at High Altitude --Zaduo County
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of reflux esophagitis
研究概览
简要总结
To prospectively enroll participants undergoing gastroscopy at Zaduo County People's Hospital and perform paired analyses with matched cases from Jilin Province. This aims to characterize the endoscopic features of esophageal diseases specific to the high-altitude population in Zaduo County.
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
- •Aged ≥18 years;
- •Resided in Zaduo County for ≥6 months;
- •Undergoing painless (sedated) gastroscopy at our institution;
- •Absence of severe cardiopulmonary diseases or other conditions contraindicating gastroscopy;
- •Voluntary provision of written informed consent.
排除标准
- •Emergency endoscopy;
- •History of partial or total esophagogastrectomy;
- •Planned endoscopic ultrasound (EUS) or endoscopic submucosal dissection (ESD);
- •Comorbidities including severe cardiac, hepatic, or renal dysfunction, or malignant tumors;
- •Pregnancy or lactation, chronic alcoholism, or psychiatric disorders precluding cooperation;
- •Participation in other interventional clinical trials within the recent past;
- •Age <18 years;
- •Incomplete endoscopic examination (e.g., poor preparation, technical failure);
- •Any other condition deemed unsuitable for participation by the investigator.
研究组 & 干预措施
Zaduo group
All eligible patients presenting to the Endoscopy Center of Zaduo County People's Hospital during the recruitment period (December 1, 2025, to October 30, 2026) will be consecutively enrolled. Located at an average altitude of >4,200 m, Zaduo County presents a unique environment for this study. Eligible patients undergoing gastroscopy within the specified timeframe will be screened according to the inclusion and exclusion criteria. Endoscopic pathological findings will be compared to identify characteristics specific to the high-altitude cohort.
干预措施: Sedated gastroscopy (Diagnostic Test)
结局指标
主要结局
Proportion of reflux esophagitis
时间窗: Within 1 week after gastroscopy
The severity of reflux esophagitis (RE) was evaluated according to the Los Angeles (LA) classification\[1\]. Mucosal breaks were defined as visible discontinuities of the esophageal squamous epithelium. The grading criteria were as follows: LA Grade A: One or more mucosal breaks, each no longer than 5 mm, confined to the mucosal folds. LA Grade B: One or more mucosal breaks longer than 5 mm, but not continuous between the tops of two mucosal folds. LA Grade C: Mucosal breaks continuous between the tops of two or more mucosal folds, involving less than 75% of the esophageal circumference. LA Grade D: Mucosal breaks involving at least 75% of the esophageal circumference. The proportion of reflux esophagitis was defined as the number of patients diagnosed with reflux esophagitis divided by the total number of enrolled participants.
次要结局
- the proportion of chronic atrophic gastritis (CAG)(Within 1 week post-gastroscopy)
- Grade of gastroesophageal flap valve (GEFV) according to the Hill classification;(Within 1 week post-gastroscopy)
- Status of Helicobacter pylori infection(Within two weeks post-gastroscopy)
研究者
Dong Yang
Doctor
Jilin University