Clinical trial NCT02506634: The Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department
Official title: The Primary Symptoms of GERD in Chinese Outpatients in Gastroenterology Department: A Cross-sectional Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Keywords: symptom
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be done in the outpatient clinic, department of Gastroenterology, first affiliated hospital, sun yet-sen university. Consecutive patients who met the inclusion criteria in the Gastroenterology clinic in the first affiliated hospital will be enrolled in the study. There will not be any randomization in the study.

Brief summary: Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with upper gastrointestinal discomfort would be included. All patients underwent upper endoscopy or an ambulatory 24-h pH(Potential Of Hydrogen) monitoring.Pathologic esophageal acid reflux was defined as the percentage total time for which a pH value \< 4 was \>4.2 % in the distal esophagus. Then, patients were treated with esomeprazole 20 mg twice daily for 28 days. The symptom scores were measured by the frequency score multiplied by the severity scores of the predominant symptom before and at the end of the treatment, and the " PPI test " was defined as positive if the overall scores of the predominant dyspeptic symptom in the fourth week decreased by \>50 % compared with those of the baseline.

GERD is defined by either 24-hour impedance-pH monitoring or positive PPI(proton pump inhibitor) test or positive result from endoscopy. The percentage of each symptom of GERD in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. The symptom of the highest percentage will be the primary symptom.

Detailed description: Primary Objective：To define the primary symptom of GERD in Chinese outpatients in Gastroenterology department Secondary Objective：1. To investigate the symptom distribution of patients who present with symptoms originated from upper gastrointestinal tract and have pathologic esophageal reflux established by 24-hour impedance-pH monitoring, upper endoscopy, or proton pump inhibitor test.

2. To evaluate the life quality of patients with atypical GERD symptoms (symptoms except heartburning and regurgitation) 3. To investigate the diagnostic value of proton pump inhibitor trial to diagnose GERD with atypical reflux symptoms 4. To investigate the predictive value of Gerd Q to diagnose GERD with atypical reflux symptoms with heartburn or regurgitation

Eligibility criteria: Inclusion Criteria:

* Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with upper gastrointestinal discomfort, such as heartburn, regurgitation, dysphagia, substernal pain, epigastric pain, epigastric burning, early satiety, postprandial fullness.
* Whose previous symptoms should last for at least 3 months and be at least 3 days per week in frequency with moderate severity.
* Able to fill in the questionaires.

Exclusion Criteria:

* gastric or duodenal ulcers, upper GI neoplasms on upper endoscopy
* severe cardiac or pulmonary diseases, diabetes or rheumatic diseases
* history of operations in the upper GI tract
* renal failure or abnormal liver function
* use of non-steroidal anti-inflammatory drugs (NSAIDs)
* allergy to esomeprazole
* Pregnancy or lactating mother

Primary outcomes:
measure: The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department
timeFrame: over 3 years
Secondary outcomes:
measure: The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms
timeFrame: over 3 years
measure: The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms
timeFrame: over 3 years
measure: The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms
timeFrame: over 3 years
measure: The Sensitivity of PPI Test for Diagnosis of GERD
timeFrame: over 3 years
measure: The Specificity of PPI Test for Diagnosis of GERD
timeFrame: over 3 years
measure: The Sensitivity of GERDQ for Diagnosis of GERD
timeFrame: over 3 years
measure: The Specificity of GERDQ for Diagnosis of GERD
timeFrame: over 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the first affiliated hospital of SYSU
state: Guangdong
Study officials:
affiliation: vice-president of the first Affiliated hospital of SYSU
name: Minhu Chen, PHD
role: STUDY_DIRECTOR
References:
citation: Zhang MY, Tan ND, Li YW, Sifrim D, Pandolfino JE, Xiao YL, Chen MH. Esophageal symptoms versus epigastric symptoms: Relevance for diagnosis of gastroesophageal reflux disease. J Dig Dis. 2020 Dec;21(12):696-704. doi: 10.1111/1751-2980.12946. Epub 2020 Nov 8.