A Retrospective Analysis of Patients With Gastroesophageal Reflux Disease Based on a Prospective Clinical Dataset
5 августа 2026 г. обновлено: 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.
Обзор исследования
Статус
Статус
Рекрутинг
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Тип исследования
Тип исследования
Наблюдательный
Регистрация (Оцененный)
Регистрация
5000
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
Контакты исследования
- Имя: Zhi zheng, Attending surgon
- Номер телефона: +86-13811132175
- Электронная почта: zhengzhi@ccmu.edu.cn
Места учебы
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Beijing Municipality
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Beijing, Beijing Municipality, Китай, 100050
- Рекрутинг
- Beijing Friendship hospital, Capital Medical University
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Контакт:
- Zhi zheng, Attending surgon
- Номер телефона: +86-13811132175
- Электронная почта: zhengzhi@ccmu.edu.cn
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
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
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Количество групп / когорт
1
Когорты и вмешательства
Группа / когортаГруппа / когорта |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
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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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Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pre- and Post-Treatment Improvement in GERD-HRQL Scores
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
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
|
Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Helicobacter pylori Infection Status
Временное ограничение: From 30 days prior to surgery to 10 years post-surgery
|
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
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
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
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
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
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
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
Временное ограничение: 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
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
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
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
Evaluated via gastroscopy according to the Los Angeles (LA) classification.
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From pre-treatment to up to 10 years post-treatment
|
|
Severity of Hiatal Hernia
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
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
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
Evaluated via gastroscopy.
|
From pre-treatment to up to 10 years post-treatment
|
|
Acid Exposure Time (AET)
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
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
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
Quantified via pH-impedance monitoring.
|
From pre-treatment to up to 10 years post-treatment
|
|
DeMeester Score
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
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)
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
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)
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
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
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
Measured via high-resolution manometry (HRM).
|
From pre-treatment to up to 10 years post-treatment
|
|
Integrated Relaxation Pressure (IRP)
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
Measured via high-resolution manometry (HRM).
|
From pre-treatment to up to 10 years post-treatment
|
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Esophagogastric Junction (EGJ) Morphology
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
Evaluated via high-resolution manometry (HRM) to assess hiatal hernia status.
|
From pre-treatment to up to 10 years post-treatment
|
|
Distal Latency (DL)
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
Measured via high-resolution manometry (HRM).
|
From pre-treatment to up to 10 years post-treatment
|
|
Distal Contractile Integral (DCI)
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
Measured via high-resolution manometry (HRM).
|
From pre-treatment to up to 10 years post-treatment
|
|
Esophageal Motility Type
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
Evaluated via high-resolution manometry (HRM) according to the Chicago classification.
|
From pre-treatment to up to 10 years post-treatment
|
|
Hiatal Hernia Size
Временное ограничение: From pre-treatment to up to 10 years post-treatment
|
Evaluated via computed tomography (CT).
|
From pre-treatment to up to 10 years post-treatment
|
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Acid-Suppressive Medication Regimen
Временное ограничение: From enrollment to the end of treatment, assessed up to 12 weeks
|
This encompasses the specific medication name, prescribed dosage, and administration frequency.
|
From enrollment to the end of treatment, assessed up to 12 weeks
|
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Operation Time
Временное ограничение: At the time of surgery
|
At the time of surgery
|
|
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Blood Loss
Временное ограничение: At the time of surgery
|
At the time of surgery
|
|
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Abdominal Drainage Fluid Volume
Временное ограничение: From treatment to 30 days after surgery
|
From treatment to 30 days after surgery
|
|
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Total Duration of Hospitalization
Временное ограничение: From treatment to 30 days after surgery
|
From treatment to 30 days after surgery
|
|
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Incidence of Postoperative Complications
Временное ограничение: From treatment to 30 days after surgery
|
From treatment to 30 days after surgery
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
Начало исследования
17 апреля 2026 г.
Первичное завершение (Оцененный)
Первичное завершение
1 апреля 2027 г.
Завершение исследования (Оцененный)
Завершение исследования
1 мая 2027 г.
Даты регистрации исследования
Первый отправленный
Первый отправленный
31 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
5 августа 2026 г.
Первый опубликованный (Действительный)
Первый опубликованный
6 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
6 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
5 августа 2026 г.
Последняя проверка
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- 2026-P2-209-01
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .