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

2026년 8월 5일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

5000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100050
        • 모병
        • Beijing Friendship hospital, Capital Medical University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pre- and Post-Treatment Improvement in GERD-HRQL Scores
기간: 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.
From pre-treatment to up to 10 years post-treatment

2차 결과 측정

결과 측정
측정값 설명
기간
Helicobacter pylori Infection Status
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
From pre-treatment to up to 10 years post-treatment
Pre- and Post-Treatment Improvement in HADS Scores
기간: 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.
From pre-treatment to up to 10 years post-treatment
Esophagitis Severity
기간: From pre-treatment to up to 10 years post-treatment
Evaluated via gastroscopy according to the Los Angeles (LA) classification.
From pre-treatment to up to 10 years post-treatment
Severity of Hiatal Hernia
기간: From pre-treatment to up to 10 years post-treatment
Evaluated via gastroscopy according to the Hill classification.
From pre-treatment to up to 10 years post-treatment
Presence of Barrett's Esophagus
기간: 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)
기간: 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
기간: 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
기간: 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.
From pre-treatment to up to 10 years post-treatment
Symptom Index (SI)
기간: 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)
기간: 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
기간: 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)
기간: 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
Esophagogastric Junction (EGJ) Morphology
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
Acid-Suppressive Medication Regimen
기간: 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
Operation Time
기간: At the time of surgery
At the time of surgery
Blood Loss
기간: At the time of surgery
At the time of surgery
Abdominal Drainage Fluid Volume
기간: From treatment to 30 days after surgery
From treatment to 30 days after surgery
Total Duration of Hospitalization
기간: From treatment to 30 days after surgery
From treatment to 30 days after surgery
Incidence of Postoperative Complications
기간: From treatment to 30 days after surgery
From treatment to 30 days after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beijing Friendship Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 17일

기본 완료 (추정된)

2027년 4월 1일

연구 완료 (추정된)

2027년 5월 1일

연구 등록 날짜

최초 제출

2026년 7월 31일

QC 기준을 충족하는 최초 제출

2026년 8월 5일

처음 게시됨 (실제)

2026년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 5일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2026-P2-209-01

개별 참가자 데이터(IPD) 계획

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아니요

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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