Gastroesophageal Reflux DiseaseNCT07749989
A Retrospective Analysis of Patients With Gastroesophageal Reflux Disease Based on a Prospective Clinical Dataset
An observational study of Gastroesophageal Reflux Disease, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This retrospective, observational cohort study aimed to establish a comprehensive research cohort utilizing a large-scale prospective clinical registry. The primary objectives were to characterize the real-world demographic profiles, clinical features, psychological characteristics, and treatment patterns of Chinese… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Clinical Data Collection
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2026to May 2027
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be drawn from the clinical registry of the National Clinical Research Center for Digestive Diseases at Beijing Friendship Hospital, Capital Medical University. This retrospective cohort study will enroll approximately 5,000 patients with a confirmed diagnosis of gastroesophageal reflux disease (GERD). During the study period, all eligible patients documented in the registry who meet the inclusion criteria will be consecutively enrolled. The source population comprises patients presenting to Beijing Friendship Hospital for the diagnosis and management of GERD. This registry encompasses comprehensive data on clinical symptoms, objective diagnostic findings, treatment details, and longitudinal follow-up outcomes for all enrolled individuals. As Beijing Friendship Hospital is a major tertiary referral center in China serving a broad geographical catchment area, the study cohort is anticipated to be highly representative of diverse patient demographics and clinical
Who may be able to join
- Aged between 18 and 90 years old.
- Patients were required to present with at least one typical symptom of gastroesophageal reflux disease (GERD)-such as heartburn, regurgitation, or non-cardiac chest pain-and to have presented to Beijing Friendship Hospital for the evaluation and management of these symptoms.
- Received treatment, including pharmacological therapy and anti-reflux surgery, at Beijing Friendship Hospital.
- Voluntary signing of informed consent, agreeing to the use of clinical information for future research.
Who cannot join
- Female patients who were pregnant or lactating.
- Patients with significantly incomplete or missing critical clinical data.
- Patients with an equivocal or unconfirmed diagnosis of GERD.
- Current neurologic or cognitive impairment, which would preclude ability to obtain informed consent.
- Refusal to participate in the study.
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
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Zhi Zheng, Attending surgon, +86-13811132175, zhengzhi@ccmu.edu.cn
About this study
Official title: Establishing an Innovative Cohort of Chinese Patients With Gastroesophageal Reflux Disease Based on the Prospective Database of the National Clinical Research Center for Digestive Diseases: A Retrospective Study
This retrospective, observational cohort study aimed to establish a comprehensive research cohort utilizing a large-scale prospective clinical registry. The primary objectives were to characterize the real-world demographic profiles, clinical features, psychological characteristics, and treatment patterns of Chinese patients with gastroesophageal reflux disease (GERD), as well as to evaluate post-treatment improvements in both GERD symptoms and psychological well-being. The study retrospectively enrolled approximately 5,000 patients with a confirmed diagnosis of GERD, with data derived from the prospective registry of the National Clinical Research Center for Digestive Diseases. Investigators systematically extracted data on baseline demographics, clinical presentations, objective diagnostic findings, preoperative psychological status, surgical complications, and longitudinal follow-up outcomes for all eligible patients. Ultimately, this study sought to provide high-quality, China-specific evidence to inform the precise phenotyping of GERD and to guide standardized, individualized clinical decision-making.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Clinical Data Collection
- Keywords
- Gastroesophageal Reflux Disease, Retrospective Cohort, Surgical Treatment, Real-World Data, Quality of Life
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Data CollectionOther
Data on clinical symptoms, treatment details, and long-term follow-up outcomes were retrospectively extracted from electronic medical records (EMRs) and institutional databases.
| Study group | Role | What they receive |
|---|---|---|
| GERD Retrospective Cohort | A retrospective cohort of approximately 5,000 patients with a confirmed diagnosis of gastroesophageal reflux disease (GERD) treated at Beijing Friendship Hospital was established using data extracted from the prospective clinical registry of the National Clinical Research Center for Digestive Diseases. Receives: Other: Clinical Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and Post-Treatment Improvement in GERD-HRQL Scores
The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire is utilized to assess patient outcomes as a quantitative variable. The scale comprises 11 items, each scored from 0 to 5, with higher scores indicating a better quality of life (QoL). Clinical success is defined as a >50% reduction in the total symptom score.
Measured: From pre-treatment to up to 10 years post-treatment
Secondary outcomes (27)
Pre- and Post-Treatment Improvement in GERD-Q Scores
The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) is utilized to evaluate GERD symptoms. The total score ranges from 0 to 18, with higher scores indicating greater symptom severity.
Measured: From pre-treatment to up to 10 years post-treatment
Pre- and Post-Treatment Improvement in GSAS Scores
The GERD Symptom Assessment Scale (GSAS) is employed to evaluate GERD symptoms. The total score ranges from 0 to 45, with higher scores indicating greater symptom severity.
Measured: From pre-treatment to up to 10 years post-treatment
Pre- and Post-Treatment Improvement in GIQLI Scores
The Gastrointestinal Quality of Life Index (GIQLI) is utilized to assess quality of life in patients with gastrointestinal diseases. It comprises five subscales with a total score ranging from 0 to 144. Higher scores indicate a better quality of life and superior therapeutic efficacy.
Measured: From pre-treatment to up to 10 years post-treatment
Pre- and Post-Treatment Improvement in EHAS Scores
The Esophageal Hypervigilance and Anxiety Scale (EHAS) is utilized to assess esophageal-specific hypervigilance and anxiety. It comprises two subscales with a total score ranging from 0 to 56, with higher scores indicating more severe esophageal hypervigilance and anxiety.
Measured: From pre-treatment to up to 10 years post-treatment
Pre- and Post-Treatment Improvement in HADS Scores
The Hospital Anxiety and Depression Scale (HADS) is employed to evaluate patient anxiety and depression. It comprises two subscales with a total score ranging from 0 to 42, with higher scores indicating more severe states of anxiety and depression.
Measured: From pre-treatment to up to 10 years post-treatment
Esophagitis Severity
Evaluated via gastroscopy according to the Los Angeles (LA) classification.
Measured: From pre-treatment to up to 10 years post-treatment
Severity of Hiatal Hernia
Evaluated via gastroscopy according to the Hill classification.
Measured: From pre-treatment to up to 10 years post-treatment
Presence of Barrett's Esophagus
Evaluated via gastroscopy.
Measured: From pre-treatment to up to 10 years post-treatment
Acid Exposure Time (AET)
Quantified via pH-impedance monitoring. AET serves as the primary and most reliable metric for diagnosing objective GERD and evaluating the true burden of acid reflux, >4% indicate abnormal acid reflux
Measured: From pre-treatment to up to 10 years post-treatment
Number of Reflux Episodes
Quantified via pH-impedance monitoring.
Measured: From pre-treatment to up to 10 years post-treatment
DeMeester Score
The DeMeester Composite Score quantifies the severity of Gastroesophageal Reflux Disease (GERD). It is calculated from 24-hour ambulatory esophageal pH monitoring using six acid exposure parameters: percentage of total, upright, and supine time with pH < 4; total reflux episodes; episodes lasting > 5 minutes; and the duration of the longest episode. Each parameter is scored using the formula SV = (X - A) / SD + 1, where X is the measured value, A is the healthy baseline mean, and SD is the baseline standard deviation. The total score is the sum of these six values. Minimum value: 0. Maximum value: No fixed upper limit (unbounded). In clinical applications, higher scores indicate more severe pathological acid exposure.
Measured: From pre-treatment to up to 10 years post-treatment
Symptom Index (SI)
Derived from pH-impedance monitoring to determine the temporal correlation between symptom events and reflux episodes, confirming whether a patient's symptoms are specifically reflux-driven. An SI of ≥ 50% is universally considered positive, indicating a clinically meaningful symptom-reflux association.
Measured: From pre-treatment to up to 10 years post-treatment
Symptom Reflux Index (SRI)
Derived from pH-impedance monitoring to provide statistical validation of the symptom-reflux association, which is crucial for accurately phenotyping functional versus organic GERD. An SRI of ≥ 95% (often utilized interchangeably with Symptom Association Probability, SAP) is considered positive, providing strong statistical evidence that symptoms are not occurring by chance.
Measured: From pre-treatment to up to 10 years post-treatment
Esophagogastric Junction (EGJ) Expiratory Pressure
Measured via high-resolution manometry (HRM).
Measured: From pre-treatment to up to 10 years post-treatment
Integrated Relaxation Pressure (IRP)
Measured via high-resolution manometry (HRM).
Measured: From pre-treatment to up to 10 years post-treatment
Esophagogastric Junction (EGJ) Morphology
Evaluated via high-resolution manometry (HRM) to assess hiatal hernia status.
Measured: From pre-treatment to up to 10 years post-treatment
Distal Latency (DL)
Measured via high-resolution manometry (HRM).
Measured: From pre-treatment to up to 10 years post-treatment
Distal Contractile Integral (DCI)
Measured via high-resolution manometry (HRM).
Measured: From pre-treatment to up to 10 years post-treatment
Esophageal Motility Type
Evaluated via high-resolution manometry (HRM) according to the Chicago classification.
Measured: From pre-treatment to up to 10 years post-treatment
Hiatal Hernia Size
Evaluated via computed tomography (CT).
Measured: From pre-treatment to up to 10 years post-treatment
Helicobacter pylori Infection Status
Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.
Measured: From 30 days prior to surgery to 10 years post-surgery
Acid-Suppressive Medication Regimen
This encompasses the specific medication name, prescribed dosage, and administration frequency.
Measured: From enrollment to the end of treatment, assessed up to 12 weeks
Operation Time
Measured: At the time of surgery
Blood Loss
Measured: At the time of surgery
Abdominal Drainage Fluid Volume
Measured: From treatment to 30 days after surgery
Total Duration of Hospitalization
Measured: From treatment to 30 days after surgery
Incidence of Postoperative Complications
Measured: From treatment to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start17 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JunZhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749989
- Sponsor's protocol ID
- 2026-P2-209-01
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 6 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing an Innovative Cohort of Chinese Patients With Gastroesophageal Reflux Disease Based on the Prospective Database of the National Clinical Research Center for Digestive Diseases: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07749989
- Acronym / sponsor ID
- 2026-P2-209-01
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux Disease, Retrospective Cohort, Surgical Treatment, Real-World Data, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 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.
This retrospective, observational cohort study aimed to establish a comprehensive research cohort utilizing a large-scale prospective clinical registry. The primary objectives were to characterize the real-world demographic profiles, clinical features, psychological characteristics, and treatment patterns of Chinese patients with gastroesophageal reflux disease (GERD), as well as to evaluate post-treatment improvements in both GERD symptoms and psychological well-being. The study retrospectively enrolled approximately 5,000 patients with a confirmed diagnosis of GERD, with data derived from the prospective registry of the National Clinical Research Center for Digestive Diseases. Investigators systematically extracted data on baseline demographics, clinical presentations, objective diagnostic findings, preoperative psychological status, surgical complications, and longitudinal follow-up outcomes for all eligible patients. Ultimately, this study sought to provide high-quality, China-specific evidence to inform the precise phenotyping of GERD and to guide standardized, individualized clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GERD Retrospective Cohort | – | Other: Clinical Data CollectionA retrospective cohort of approximately 5,000 patients with a confirmed diagnosis of gastroesophageal reflux disease (GERD) treated at Beijing Friendship Hospital was established using data extracted from the prospective clinical registry of the National Clinical Research Center for Digestive Diseases. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be drawn from the clinical registry of the National Clinical Research Center for Digestive Diseases at Beijing Friendship Hospital, Capital Medical University. This retrospective cohort study will enroll approximately 5,000 patients with a confirmed diagnosis of gastroesophageal reflux disease (GERD). During the study period, all eligible patients documented in the registry who meet the inclusion criteria will be consecutively enrolled. The source population comprises patients presenting to Beijing Friendship Hospital for the diagnosis and management of GERD. This registry encompasses comprehensive data on clinical symptoms, objective diagnostic findings, treatment details, and longitudinal follow-up outcomes for all enrolled individuals. As Beijing Friendship Hospital is a major tertiary referral center in China serving a broad geographical catchment area, the study cohort is anticipated to be highly representative of diverse patient demographics and clinical
Key inclusion criteria (4 listed)
- Aged between 18 and 90 years old.
- Patients were required to present with at least one typical symptom of gastroesophageal reflux disease (GERD)-such as heartburn, regurgitation, or non-cardiac chest pain-and to have presented to Beijing Friendship Hospital for the evaluation and management of these symptoms.
- Received treatment, including pharmacological therapy and anti-reflux surgery, at Beijing Friendship Hospital.
- Voluntary signing of informed consent, agreeing to the use of clinical information for future research.
Key exclusion criteria (5 listed)
- Female patients who were pregnant or lactating.
- Patients with significantly incomplete or missing critical clinical data.
- Patients with an equivocal or unconfirmed diagnosis of GERD.
- Current neurologic or cognitive impairment, which would preclude ability to obtain informed consent.
- Refusal to participate in the study.
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 |
|---|---|---|
| Clinical Data CollectionData on clinical symptoms, treatment details, and long-term follow-up outcomes were retrospectively extracted from electronic medical records (EMRs) and institutional databases. | Other | GERD Retrospective Cohort |
Primary outcome
Pre- and Post-Treatment Improvement in GERD-HRQL Scores
Time frame: From pre-treatment to up to 10 years post-treatment
The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire is utilized to assess patient outcomes as a quantitative variable. The scale comprises 11 items, each scored from 0 to 5, with higher scores indicating a better quality of life (QoL). Clinical success is defined as a >50% reduction in the total symptom score.
27 secondary outcomes
Pre- and Post-Treatment Improvement in GERD-Q Scores
Time frame: From pre-treatment to up to 10 years post-treatment
Pre- and Post-Treatment Improvement in GSAS Scores
Time frame: From pre-treatment to up to 10 years post-treatment
Pre- and Post-Treatment Improvement in GIQLI Scores
Time frame: From pre-treatment to up to 10 years post-treatment
Pre- and Post-Treatment Improvement in EHAS Scores
Time frame: From pre-treatment to up to 10 years post-treatment
Pre- and Post-Treatment Improvement in HADS Scores
Time frame: From pre-treatment to up to 10 years post-treatment
Esophagitis Severity
Time frame: From pre-treatment to up to 10 years post-treatment
Severity of Hiatal Hernia
Time frame: From pre-treatment to up to 10 years post-treatment
Presence of Barrett's Esophagus
Time frame: From pre-treatment to up to 10 years post-treatment
Acid Exposure Time (AET)
Time frame: From pre-treatment to up to 10 years post-treatment
Number of Reflux Episodes
Time frame: From pre-treatment to up to 10 years post-treatment
DeMeester Score
Time frame: From pre-treatment to up to 10 years post-treatment
Symptom Index (SI)
Time frame: From pre-treatment to up to 10 years post-treatment
Symptom Reflux Index (SRI)
Time frame: From pre-treatment to up to 10 years post-treatment
Esophagogastric Junction (EGJ) Expiratory Pressure
Time frame: From pre-treatment to up to 10 years post-treatment
Integrated Relaxation Pressure (IRP)
Time frame: From pre-treatment to up to 10 years post-treatment
Esophagogastric Junction (EGJ) Morphology
Time frame: From pre-treatment to up to 10 years post-treatment
Distal Latency (DL)
Time frame: From pre-treatment to up to 10 years post-treatment
Distal Contractile Integral (DCI)
Time frame: From pre-treatment to up to 10 years post-treatment
Esophageal Motility Type
Time frame: From pre-treatment to up to 10 years post-treatment
Hiatal Hernia Size
Time frame: From pre-treatment to up to 10 years post-treatment
Helicobacter pylori Infection Status
Time frame: From 30 days prior to surgery to 10 years post-surgery
Acid-Suppressive Medication Regimen
Time frame: From enrollment to the end of treatment, assessed up to 12 weeks
Operation Time
Time frame: At the time of surgery
Blood Loss
Time frame: At the time of surgery
Abdominal Drainage Fluid Volume
Time frame: From treatment to 30 days after surgery
Total Duration of Hospitalization
Time frame: From treatment to 30 days after surgery
Incidence of Postoperative Complications
Time frame: From treatment to 30 days after surgery
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 6 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.
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 Gastroesophageal Reflux Disease, run by Beijing Friendship Hospital 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 4 inclusion and 5 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 6 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 Zhi Zheng, Attending surgon (+86-13811132175, zhengzhi@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre- and Post-Treatment Improvement in GERD-HRQL Scores (time frame: From pre-treatment to up to 10 years post-treatment). 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 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.