A Retrospective Analysis of Patients With Gastroesophageal Reflux Disease Based on a Prospective Clinical Dataset
5 de agosto de 2026 atualizado por: JunZhang, Beijing Friendship Hospital
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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
5000
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Zhi zheng, Attending surgon
- Número de telefone: +86-13811132175
- E-mail: zhengzhi@ccmu.edu.cn
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100050
- Recrutamento
- Beijing Friendship hospital, Capital Medical University
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Contato:
- Zhi zheng, Attending surgon
- Número de telefone: +86-13811132175
- E-mail: zhengzhi@ccmu.edu.cn
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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.
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Data on clinical symptoms, treatment details, and long-term follow-up outcomes were retrospectively extracted from electronic medical records (EMRs) and institutional databases.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pre- and Post-Treatment Improvement in GERD-HRQL Scores
Prazo: From pre-treatment to up to 10 years post-treatment
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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.
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From pre-treatment to up to 10 years post-treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Helicobacter pylori Infection Status
Prazo: From 30 days prior to surgery to 10 years post-surgery
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Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.
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From 30 days prior to surgery to 10 years post-surgery
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Pre- and Post-Treatment Improvement in GERD-Q Scores
Prazo: From pre-treatment to up to 10 years post-treatment
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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.
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From pre-treatment to up to 10 years post-treatment
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Pre- and Post-Treatment Improvement in GSAS Scores
Prazo: From pre-treatment to up to 10 years post-treatment
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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.
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From pre-treatment to up to 10 years post-treatment
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Pre- and Post-Treatment Improvement in GIQLI Scores
Prazo: From pre-treatment to up to 10 years post-treatment
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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.
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From pre-treatment to up to 10 years post-treatment
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Pre- and Post-Treatment Improvement in EHAS Scores
Prazo: From pre-treatment to up to 10 years post-treatment
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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.
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From pre-treatment to up to 10 years post-treatment
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Pre- and Post-Treatment Improvement in HADS Scores
Prazo: From pre-treatment to up to 10 years post-treatment
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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.
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From pre-treatment to up to 10 years post-treatment
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Esophagitis Severity
Prazo: From pre-treatment to up to 10 years post-treatment
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Evaluated via gastroscopy according to the Los Angeles (LA) classification.
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From pre-treatment to up to 10 years post-treatment
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Severity of Hiatal Hernia
Prazo: From pre-treatment to up to 10 years post-treatment
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Evaluated via gastroscopy according to the Hill classification.
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From pre-treatment to up to 10 years post-treatment
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Presence of Barrett's Esophagus
Prazo: From pre-treatment to up to 10 years post-treatment
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Evaluated via gastroscopy.
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From pre-treatment to up to 10 years post-treatment
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Acid Exposure Time (AET)
Prazo: From pre-treatment to up to 10 years post-treatment
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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
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From pre-treatment to up to 10 years post-treatment
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Number of Reflux Episodes
Prazo: From pre-treatment to up to 10 years post-treatment
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Quantified via pH-impedance monitoring.
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From pre-treatment to up to 10 years post-treatment
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DeMeester Score
Prazo: From pre-treatment to up to 10 years post-treatment
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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.
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From pre-treatment to up to 10 years post-treatment
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Symptom Index (SI)
Prazo: From pre-treatment to up to 10 years post-treatment
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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.
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From pre-treatment to up to 10 years post-treatment
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Symptom Reflux Index (SRI)
Prazo: From pre-treatment to up to 10 years post-treatment
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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.
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From pre-treatment to up to 10 years post-treatment
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Esophagogastric Junction (EGJ) Expiratory Pressure
Prazo: From pre-treatment to up to 10 years post-treatment
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Measured via high-resolution manometry (HRM).
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From pre-treatment to up to 10 years post-treatment
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Integrated Relaxation Pressure (IRP)
Prazo: From pre-treatment to up to 10 years post-treatment
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Measured via high-resolution manometry (HRM).
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From pre-treatment to up to 10 years post-treatment
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Esophagogastric Junction (EGJ) Morphology
Prazo: From pre-treatment to up to 10 years post-treatment
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Evaluated via high-resolution manometry (HRM) to assess hiatal hernia status.
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From pre-treatment to up to 10 years post-treatment
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Distal Latency (DL)
Prazo: From pre-treatment to up to 10 years post-treatment
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Measured via high-resolution manometry (HRM).
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From pre-treatment to up to 10 years post-treatment
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Distal Contractile Integral (DCI)
Prazo: From pre-treatment to up to 10 years post-treatment
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Measured via high-resolution manometry (HRM).
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From pre-treatment to up to 10 years post-treatment
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Esophageal Motility Type
Prazo: From pre-treatment to up to 10 years post-treatment
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Evaluated via high-resolution manometry (HRM) according to the Chicago classification.
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From pre-treatment to up to 10 years post-treatment
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Hiatal Hernia Size
Prazo: From pre-treatment to up to 10 years post-treatment
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Evaluated via computed tomography (CT).
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From pre-treatment to up to 10 years post-treatment
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Acid-Suppressive Medication Regimen
Prazo: From enrollment to the end of treatment, assessed up to 12 weeks
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This encompasses the specific medication name, prescribed dosage, and administration frequency.
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From enrollment to the end of treatment, assessed up to 12 weeks
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Operation Time
Prazo: At the time of surgery
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At the time of surgery
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Blood Loss
Prazo: At the time of surgery
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At the time of surgery
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Abdominal Drainage Fluid Volume
Prazo: From treatment to 30 days after surgery
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From treatment to 30 days after surgery
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Total Duration of Hospitalization
Prazo: From treatment to 30 days after surgery
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From treatment to 30 days after surgery
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Incidence of Postoperative Complications
Prazo: From treatment to 30 days after surgery
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From treatment to 30 days after surgery
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
17 de abril de 2026
Conclusão Primária (Estimado)
1 de abril de 2027
Conclusão do estudo (Estimado)
1 de maio de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
31 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de agosto de 2026
Primeira postagem (Real)
6 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-P2-209-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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