A Retrospective Analysis of Patients With Gastroesophageal Reflux Disease Based on a Prospective Clinical Dataset
5 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Interwencja / Leczenie
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
5000
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Zhi zheng, Attending surgon
- Numer telefonu: +86-13811132175
- E-mail: zhengzhi@ccmu.edu.cn
Lokalizacje studiów
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Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 100050
- Rekrutacyjny
- Beijing Friendship hospital, Capital Medical University
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Kontakt:
- Zhi zheng, Attending surgon
- Numer telefonu: +86-13811132175
- E-mail: zhengzhi@ccmu.edu.cn
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pre- and Post-Treatment Improvement in GERD-HRQL Scores
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Helicobacter pylori Infection Status
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At the time of surgery
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At the time of surgery
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Blood Loss
Ramy czasowe: At the time of surgery
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At the time of surgery
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Abdominal Drainage Fluid Volume
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: From treatment to 30 days after surgery
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From treatment to 30 days after surgery
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Współpracownicy i badacze
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
17 kwietnia 2026
Zakończenie podstawowe (Szacowany)
1 kwietnia 2027
Ukończenie studiów (Szacowany)
1 maja 2027
Daty rejestracji na studia
Pierwszy przesłany
31 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
5 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
6 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
6 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
5 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-P2-209-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .