A Prospective Cohort Study on Endoscopic Features of Upper Gastrointestinal Tract at High Altitude (Zaduo County)

NCT07755384 | Recruiting

• 1 other identifier: 815300
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reflux Esophagitis

Keywords

High altitude; Reflux esophagitis; Hypoxia; Lower esophageal sphincter; Atrophic gastritis; Helicobacter pylori infection

Outcome Measures

Primary Outcomes (1)

• Proportion of reflux esophagitis

  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.

  Within 1 week after gastroscopy

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Diagnostic Test: Sedated gastroscopy

Interventions

Sedated gastroscopy DIAGNOSTIC_TEST

All enrolled patients underwent sedated gastroscopy.

Zaduo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients scheduled for gastroscopy at the Endoscopy Center of Zaduo County People's Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jilin University: lead
• Zaduo County People's Hospital: collaborator

Study Sites (1)

Zaduo County People's Hospital

Yushu, Qinghai, 815300, China

RECRUITING

MeSH Terms

Conditions

Esophagitis, Peptic; Altitude Sickness; Hypoxia; Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastritis

Study Officials

• Dong Yang, Doctor

  Zaduo County People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rucai Li, Doctor

CONTACT

86-18397118370; 1271025352@qq.com

Dong Yang, Doctor

CONTACT

86-18243052038; yang_dong@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)