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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07755384
Enrollment
60
Registered
2026-08-10
Start date
2025-12-01
Completion date
2026-12-31
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux Esophagitis

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTSedated gastroscopy

All enrolled patients underwent sedated gastroscopy.

Sponsors

Jilin University
Lead SponsorOTHER
Zaduo County People's Hospital
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of reflux esophagitisWithin 1 week after gastroscopyThe 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.

Secondary

MeasureTime frameDescription
the proportion of chronic atrophic gastritis (CAG)Within 1 week post-gastroscopyThe extent of gastric atrophy was determined by tracing the endoscopic atrophic border (the "cut-off line"). Based on the location of the endoscopic atrophic border, Kimura and Takemoto proposed an endoscopic classification of gastric atrophy comprising two main types: closed type (C type) and open type (O type). These two main types are further subdivided into three closed types (C-1, C-2, and C-3) and three open types (O-1, O-2, and O-3). Closed type C-1 is characterized by endoscopic atrophic changes confined to the antrum. In types C-2 and C-3, the atrophic changes extend parabolically above the angulus. The differentiation between C-2 and C-3 is based on the location of the atrophic border in relation to the middle of the lesser curvature of the stomach: in C-2, the atrophic border lies below this level, whereas in C-3, it lies above it. In the open types, the atrophic border lies between the lesser curvature and the anterior wall in O-1, on the anterior wall in O-2, and between
Grade of gastroesophageal flap valve (GEFV) according to the Hill classification;Within 1 week post-gastroscopyAssessment of the Gastroesophageal Flap Valve (GEFV) The appearance and compliance of the GEFV during quiet respiration were graded according to the Hill classification: Grade I: The GEFV appears as a well-defined, symmetrical fold compressing the tip of the endoscope. Grade II: The GEFV appears as a poorly defined, wavy fold that opens with respiration, allowing partial visualization of the cardia. Grade III: The GEFV is absent; the cardia is clearly visible and opens widely with respiration, exposing the gastric fundus. Grade IV: The cardia is permanently open, exhibiting a hiatal hernia appearance with retrograde prolapse of the gastric mucosa into the esophagus.
Status of Helicobacter pylori infectionWithin two weeks post-gastroscopyBased on the urea breath test results, endoscopic findings, and the history of H. pylori eradication therapy, infec-tion status was divided into three groups: negative, positive, and eradication. Positive status was defined as a positive urea breath test or endoscopic features suggestive of current Helicobacter pylori infection. Eradication status was defined as negative urea breath test together with either a documented his-tory of eradication therapy or definite endoscopic atrophy (Kimura-Takemoto grade ≥ C-II, that is, the atrophic border extending beyond the gastric angle). The remaining cases were considered to be H. pylori-negative.

Countries

China

Contacts

CONTACTRucai Li, Doctor
1271025352@qq.com86-18397118370
CONTACTDong Yang, Doctor
yang_dong@jlu.edu.cn86-18243052038
PRINCIPAL_INVESTIGATORDong Yang, Doctor

Zaduo County People's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026