A Retrospective Analysis of Patients With Gastroesophageal Reflux Disease Based on a Prospective Clinical Dataset
5 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
De observación
Inscripción (Estimado)
Inscripción
5000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Zhi zheng, Attending surgon
- Número de teléfono: +86-13811132175
- Correo electrónico: zhengzhi@ccmu.edu.cn
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100050
- Reclutamiento
- Beijing Friendship hospital, Capital Medical University
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Contacto:
- Zhi zheng, Attending surgon
- Número de teléfono: +86-13811132175
- Correo electrónico: zhengzhi@ccmu.edu.cn
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
1
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pre- and Post-Treatment Improvement in GERD-HRQL Scores
Periodo de tiempo: 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 resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Helicobacter pylori Infection Status
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From pre-treatment to up to 10 years post-treatment
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At the time of surgery
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At the time of surgery
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Blood Loss
Periodo de tiempo: At the time of surgery
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At the time of surgery
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Abdominal Drainage Fluid Volume
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
17 de abril de 2026
Finalización primaria (Estimado)
Finalización primaria
1 de abril de 2027
Finalización del estudio (Estimado)
Finalización del estudio
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
5 de agosto de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
6 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
6 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
5 de agosto de 2026
Última verificación
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2026-P2-209-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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