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Recruiting NCT07749989

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

— Observational Gastroesophageal Reflux Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical Data Collection.
Who it may be relevant to
Registry conditions: Gastroesophageal Reflux Disease. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Pre- and Post-Treatment Improvement in GERD-HRQL Scores [Time frame: From pre-treatment to up to 10 years post-treatment]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Friendship Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07749989 · 2026-P2-209-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗