A Retrospective Analysis of Patients With Gastroesophageal Reflux Disease Based on a Prospective Clinical Dataset

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Other: Clinical Data Collection

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Zhi zheng, Attending surgon; Phone Number: +86-13811132175; Email: zhengzhi@ccmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Zhi zheng, Attending surgon; Phone Number: +86-13811132175; Email: zhengzhi@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From pre-treatment to up to 10 years post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori Infection Status	Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.	From 30 days prior to surgery to 10 years post-surgery
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.	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.	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.	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.	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.	From pre-treatment to up to 10 years post-treatment
Esophagitis Severity	Evaluated via gastroscopy according to the Los Angeles (LA) classification.	From pre-treatment to up to 10 years post-treatment
Severity of Hiatal Hernia	Evaluated via gastroscopy according to the Hill classification.	From pre-treatment to up to 10 years post-treatment
Presence of Barrett's Esophagus	Evaluated via gastroscopy.	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	From pre-treatment to up to 10 years post-treatment
Number of Reflux Episodes	Quantified via pH-impedance monitoring.	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.	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.	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.	From pre-treatment to up to 10 years post-treatment
Esophagogastric Junction (EGJ) Expiratory Pressure	Measured via high-resolution manometry (HRM).	From pre-treatment to up to 10 years post-treatment
Integrated Relaxation Pressure (IRP)	Measured via high-resolution manometry (HRM).	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.	From pre-treatment to up to 10 years post-treatment
Distal Latency (DL)	Measured via high-resolution manometry (HRM).	From pre-treatment to up to 10 years post-treatment
Distal Contractile Integral (DCI)	Measured via high-resolution manometry (HRM).	From pre-treatment to up to 10 years post-treatment
Esophageal Motility Type	Evaluated via high-resolution manometry (HRM) according to the Chicago classification.	From pre-treatment to up to 10 years post-treatment
Hiatal Hernia Size	Evaluated via computed tomography (CT).	From pre-treatment to up to 10 years post-treatment
Acid-Suppressive Medication Regimen	This encompasses the specific medication name, prescribed dosage, and administration frequency.	From enrollment to the end of treatment, assessed up to 12 weeks
Operation Time		At the time of surgery
Blood Loss		At the time of surgery
Abdominal Drainage Fluid Volume		From treatment to 30 days after surgery
Total Duration of Hospitalization		From treatment to 30 days after surgery
Incidence of Postoperative Complications		From treatment to 30 days after surgery

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: July 31, 2026
• First Submitted That Met QC Criteria: August 5, 2026
• First Posted (Actual): August 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Gastroesophageal Reflux Disease; Surgical Treatment; Real-World Data; Retrospective Cohort
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: 2026-P2-209-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No