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RecruitingNCT07755384Updated Aug 10, 2026

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

An observational study in Reflux Esophagitis, sponsored by Jilin University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Jilin University · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Reflux Esophagitis

Keywords

  • High altitude; Reflux esophagitis; Hypoxia; Lower esophageal sphincter; Atrophic gastritis; Helicobacter pylori infection
03

In context

Esophagitis, Peptic

83 studies on the registry are indexed under Esophagitis, Peptic; 16 are open to participants now.

This study's planned enrollment of 60 is below the median of 535 across 22 observational studies indexed under Esophagitis, Peptic.

Browse Esophagitis, Peptic studies →

Lead sponsor

Jilin University is the lead sponsor of 27 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testSedated gastroscopy

    All enrolled patients underwent sedated gastroscopy.

06

What researchers measure

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.

    Time frame: Within 1 week after gastroscopy

Secondary outcomes

  1. the proportion of chronic atrophic gastritis (CAG)

    The 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

    Time frame: Within 1 week post-gastroscopy

  2. Grade of gastroesophageal flap valve (GEFV) according to the Hill classification;

    Assessment 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.

    Time frame: Within 1 week post-gastroscopy

  3. Status of Helicobacter pylori infection

    Based 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.

    Time frame: Within two weeks post-gastroscopy

07

Study locations

1 of 1 sites recruiting
  • Zaduo County People's Hospital
    Yushu, Qinghai 815300, China
    Recruiting
    • Ruicai Li, Doctor · Contact1271025352@qq.com · 86-18397118370
    • Dong Yang, Doctor · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07755384
Lead sponsor
Jilin University
Collaborators
Zaduo County People's Hospital
Responsible party
Dong Yang (Doctor, Jilin University) — Principal investigator
First posted
Aug 10, 2026
Start date
Dec 1, 2025
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 10, 2026

Study contacts

Rucai Li, Doctor
Contact
1271025352@qq.com
86-18397118370
Dong Yang, Doctor
Contact
yang_dong@jlu.edu.cn
86-18243052038
Dong Yang, Doctor
principal investigator · Zaduo County People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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