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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with upper gastrointestinal symptoms | Participants are stratified at baseline based on their main upper gastrointestinal symptoms and then evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). Patients would then be given Esomeprazole MUPS（ Multiple Unit Pellet System）20 mg bid for evaluating the ability of the PPI Test for GERD. According to the guidelines, the duraion of PPI treatment was 4 weeks and 8 weeks for endoscopy negative patients and patients has reflux esophagitis, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole MUPS, 20 mg | Drug | According to the guidelines, the PPI treatment duration would be 8 weeks(Esomeprazole MUPS, 20 mg bid) for patients with reflux esophagitis and 4 weeks (Esomeprazole MUPS, 20 mg bid) for patients with normal findings on endoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | GERD can be diagnosed by more than one different criteria (i.e."reflux esophagitis on endoscopy"; "positive acid exposure time (AET) on reflux monitoring";"Either reflux esophagitis on endoscopy or positive AET on reflux monitoring") in a single participant. When different criteria was used to diagnose GERD, the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom. | over 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with different main symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. | over 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Minhu Chen, PHD | vice-president of the first Affiliated hospital of SYSU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first affiliated hospital of SYSU | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32975045 | Derived | 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. |
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The current study was a single Arm study where all participants with upper GI symptoms were enrolled and tested for gastro-esophageal reflux disease (GERD) via endoscopy and 24-hour reflux monitoring. Participants were then given proton pump inhibitor(PPI) treatment and the course was decided base on the endoscopy findings.
Four hundred consecutive patients with upper gastrointestinal (GI) symptoms were screened, 19 patients who didn't meet the inclusion criteria and 7 patients with major motility disorders on high resolution manometry were excluded. Thus, a total of 374 patients were finally enrolled in the current study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Upper GI Symptoms | Participants were stratified at baseline based on their main gastrointestinal symptoms and then evaluated for GERD using different methods. They also recieved PPI treatment (Esomeprazole MUPS, 20 mg, bid, 4 or 8 weeks) and finished GERDQ. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The aim of the current study was to investigate the symptom spectrum of GERD, and patients presented with upper GI symptoms including heartburn, regurgitation, chest pain, dysphagia, epigastric pain, epigastric burning, early satiety and postprandial fullness were enrolled. Baseline analysis population was based on patients' predominant symptom.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Predominant Heartburn | Patients with predominant heartburn were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. |
| BG001 | Patients With Predominant Regurgitation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | GERD can be diagnosed by more than one different criteria (i.e."reflux esophagitis on endoscopy"; "positive acid exposure time (AET) on reflux monitoring";"Either reflux esophagitis on endoscopy or positive AET on reflux monitoring") in a single participant. When different criteria was used to diagnose GERD, the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom. | GERD is diagnosed based on different criteria among 374 enrolled patients, and then the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom. | Posted | Count of Participants | Participants | over 3 years |
|
over 3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Who Received PPI Treatment | The frequency of adverse events among patients who received PPI treatment was calculated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | There was one serious adverse event (SAE) that a patient had pneumothorax during the treatment phase and withdrew from the study, which had no causality with any drug or study procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Niandi Tan | FirstSunYetSen | +86 15989117039 | tanniandi@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2018 | Jul 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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|
| The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with different main baseline symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. | over 3 years |
| 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 | The life quality of GERD patients with different main symptoms before PPI test will be measured via the MOS 36-item short form health survey (SF-36), in which higher scores mean a better quality of life. Its maximum score is 796.5, and the minimum score is 36.5. | over 3 years |
| The Sensitivity of PPI Test for Diagnosis of GERD | The sensitivity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD. | over 3 years |
| The Specificity of PPI Test for Diagnosis of GERD | The specificity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD. | over 3 years |
| The Sensitivity of GERDQ for Diagnosis of GERD | The sensitivity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD. | over 3 years |
| The Specificity of GERDQ for Diagnosis of GERD | The specificity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD. | over 3 years |
Patients with predominant regurgitation were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. |
| BG002 | Patients With Predominant Chest Pain | Patients with predominant chest pain were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. |
| BG003 | Patients With Predominant Dysphagia | Patients with predominant dysphagia were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. |
| BG004 | Patients With Predominant Epigastric Pain | Patients with predominant epigastric pain were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. |
| BG005 | Patients With Predominant Epigastric Burning | Patients with predominant epigastric burning were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. |
| BG006 | Patients With Predominant Postprandial Fullness | Patients with predominant postprandial fullness were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. |
| BG007 | Patients With Predominant Early Satiety | Patients with predominant early satiety were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
The percentage of GERD patients with different predominant symptom will be calculated.
| OG001 | GERD Patients Defined by Positive AET on Reflux Monitoring | The percentage of GERD patients with different predominant symptom will be calculated. |
| OG002 | GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The percentage of GERD patients with different predominant symptom will be calculated. |
|
|
| Secondary | The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with different main symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. | Among 374 enrolled patients presented with different main symptom, the percentage of patients with reflux esophagitis was calculated. | Posted | Count of Participants | Participants | over 3 years |
|
|
|
| Secondary | The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with different main baseline symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. | Among 374 enrolled patients presented with different main symptom, the percentage of patients with pathological acid reflux was calculated. | Posted | Count of Participants | Participants | over 3 years |
|
|
|
| Secondary | 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 | The life quality of GERD patients with different main symptoms before PPI test will be measured via the MOS 36-item short form health survey (SF-36), in which higher scores mean a better quality of life. Its maximum score is 796.5, and the minimum score is 36.5. | The analysis population for this outcome measure was patients with a GERD diagnosis by either reflux esophagitis on upper endoscopy or positive acid exposure time(AET) on reflux monitoring. | Posted | Mean | Standard Deviation | score on a scale | over 3 years |
|
|
|
| Secondary | The Sensitivity of PPI Test for Diagnosis of GERD | The sensitivity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD. | This outcome measure is the sensitivity of PPI test for GERD diagnosis, so the whole analysis population would be patients who finished PPI treatment. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety. | Posted | Number | Percentage of true positive | over 3 years |
|
|
|
| Secondary | The Specificity of PPI Test for Diagnosis of GERD | The specificity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD. | This outcome measure is the specificity of PPI test for GERD diagnosis, so the whole analysis population would be patients who finished PPI treatment. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety. | Posted | Number | Percentage of true negative | over 3 years |
|
|
|
| Secondary | The Sensitivity of GERDQ for Diagnosis of GERD | The sensitivity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD. | This outcome measure is the sensitivity of GERDQ for GERD diagnosis, so the whole analysis population would be patients who finished GERDQ. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety. | Posted | Number | Percentage of true positive | over 3 years |
|
|
|
| Secondary | The Specificity of GERDQ for Diagnosis of GERD | The specificity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD. | This outcome measure is the specificity of GERDQ for GERD diagnosis, so the whole analysis population would be patients who finished GERDQ. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety. | Posted | Number | Percentage of true negative | over 3 years |
|
|
|
| 0 |
| 357 |
| 1 |
| 357 |
| 42 |
| 357 |
|
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bitter taste | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
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| D004066 | Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Male |
|