Reflux EsophagitisNCT07755384
A Prospective Cohort Study on Endoscopic Features of Upper Gastrointestinal Tract at High Altitude (Zaduo County)
An observational study of Reflux Esophagitis, run by Jilin University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reflux Esophagitis
- What is being tested?
- Sedated gastroscopy
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for gastroscopy at the Endoscopy Center of Zaduo County People's Hospital
Who may be able to join
- 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.
Who cannot join
- 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;
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- Age <18 years;
- Incomplete endoscopic examination (e.g., poor preparation, technical failure);
- Any other condition deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zaduo County People's Hospital
Yushu, Qinghai, 815300
Ruicai Li, Doctor, 86-18397118370, 1271025352@qq.com
Dong Yang, Doctor
About this study
Official title: 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.
- Conditions
- Reflux Esophagitis
- Being tested
- Sedated gastroscopy
- Keywords
- High altitude; Reflux esophagitis; Hypoxia; Lower esophageal sphincter; Atrophic gastritis; Helicobacter pylori infection
- Medical subject headings
- Esophagitis, Peptic, Altitude Sickness, Hypoxia, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedated gastroscopyDiagnostic test
All enrolled patients underwent sedated gastroscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Sedated gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 week after gastroscopy
Secondary outcomes (3)
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
Measured: Within 1 week post-gastroscopy
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.
Measured: Within 1 week post-gastroscopy
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.
Measured: Within two weeks post-gastroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Dec 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- Zaduo County People's Hospital
- Responsible party
- Principal investigator, Dong Yang, Jilin University
- Investigators
- Dong Yang, Doctor, Principal investigator, Zaduo County People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755384
- Sponsor's protocol ID
- 815300
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on Endoscopic Features of Upper Gastrointestinal Tract at High Altitude --Zaduo County
- ClinicalTrials.gov ID
- NCT07755384
- Acronym / sponsor ID
- 815300
- Conditions
- Reflux Esophagitis
- Keywords
- High altitude; Reflux esophagitis; Hypoxia; Lower esophageal sphincter; Atrophic gastritis; Helicobacter pylori infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jilin UniversityUniversity, hospital or other
- Collaborators
- Zaduo County People's Hospital
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zaduo group | – | Diagnostic Test: Sedated gastroscopyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for gastroscopy at the Endoscopy Center of Zaduo County People's Hospital
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedated gastroscopyAll enrolled patients underwent sedated gastroscopy. | Diagnostic test | Zaduo group |
Primary outcome
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.
3 secondary outcomes
the proportion of chronic atrophic gastritis (CAG)
Time frame: Within 1 week post-gastroscopy
Grade of gastroesophageal flap valve (GEFV) according to the Hill classification;
Time frame: Within 1 week post-gastroscopy
Status of Helicobacter pylori infection
Time frame: Within two weeks post-gastroscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong Yang, Doctor principal investigator
Zaduo County People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reflux Esophagitis, run by Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rucai Li, Doctor (86-18397118370, 1271025352@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of reflux esophagitis (time frame: Within 1 week after gastroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.