An observational study in Gastroesophageal Reflux Disease, sponsored by Beijing Friendship Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Beijing Friendship Hospital · Observational
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.
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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
Exclusion Criteria:
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.
Other: Clinical Data Collection
Data on clinical symptoms, treatment details, and long-term follow-up outcomes were retrospectively extracted from electronic medical records (EMRs) and institutional databases.
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.
Time frame: From pre-treatment to up to 10 years post-treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From pre-treatment to up to 10 years post-treatment
Esophagitis Severity
Evaluated via gastroscopy according to the Los Angeles (LA) classification.
Time frame: From pre-treatment to up to 10 years post-treatment
Severity of Hiatal Hernia
Evaluated via gastroscopy according to the Hill classification.
Time frame: From pre-treatment to up to 10 years post-treatment
Presence of Barrett's Esophagus
Evaluated via gastroscopy.
Time frame: 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
Time frame: From pre-treatment to up to 10 years post-treatment
Number of Reflux Episodes
Quantified via pH-impedance monitoring.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From pre-treatment to up to 10 years post-treatment
Esophagogastric Junction (EGJ) Expiratory Pressure
Measured via high-resolution manometry (HRM).
Time frame: From pre-treatment to up to 10 years post-treatment
Integrated Relaxation Pressure (IRP)
Measured via high-resolution manometry (HRM).
Time frame: 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.
Time frame: From pre-treatment to up to 10 years post-treatment
Distal Latency (DL)
Measured via high-resolution manometry (HRM).
Time frame: From pre-treatment to up to 10 years post-treatment
Distal Contractile Integral (DCI)
Measured via high-resolution manometry (HRM).
Time frame: From pre-treatment to up to 10 years post-treatment
Esophageal Motility Type
Evaluated via high-resolution manometry (HRM) according to the Chicago classification.
Time frame: From pre-treatment to up to 10 years post-treatment
Hiatal Hernia Size
Evaluated via computed tomography (CT).
Time frame: 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.
Time frame: 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.
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
Plan to share: No
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Beijing Friendship Hospital