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NCT Number: NCT07755384

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zaduo County People's Hospital

Yushu, Qinghai, 815300, China

Location status: Recruiting

Location contact

Dong Yang, Doctor

PRINCIPAL_INVESTIGATOR

Ruicai Li, Doctor

CONTACT

[email protected]

86-18397118370

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sedated gastroscopy

Diagnostic Test

All enrolled patients underwent sedated gastroscopy.

Primary outcomes

  1. Proportion of reflux esophagitis

    Time frame: 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.

Secondary outcomes

  1. the proportion of chronic atrophic gastritis (CAG)

    Time frame: Within 1 week post-gastroscopy

    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

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

    Time frame: Within 1 week post-gastroscopy

    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.

  3. Status of Helicobacter pylori infection

    Time frame: Within two weeks post-gastroscopy

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Yang, Doctor

CONTACT

[email protected]

86-18243052038

Rucai Li, Doctor

CONTACT

[email protected]

86-18397118370

Sponsors and collaborators

Lead sponsor

Jilin University

Other

Collaborators

  • Zaduo County People's Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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