The Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department
Sponsor
First Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Completed
CT.gov ID
NCT02506634
Collaborator
(none)
374
1
41
9.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
- 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
Study Design
Study Type:
Observational
Actual Enrollment
:
374 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Primary Symptoms of GERD in Chinese Outpatients in Gastroenterology Department: A Cross-sectional Investigation
Study Start Date
:
Aug 1, 2015
Actual Primary Completion Date
:
Jan 1, 2019
Actual Study Completion Date
:
Jan 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Esomeprazole MUPS, 20 mg
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department [over 3 years]
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.
Secondary Outcome Measures
- The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms [over 3 years]
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.
- The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms [over 3 years]
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.
- 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 [over 3 years]
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 Sensitivity of PPI Test for Diagnosis of GERD [over 3 years]
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.
- The Specificity of PPI Test for Diagnosis of GERD [over 3 years]
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.
- The Sensitivity of GERDQ for Diagnosis of GERD [over 3 years]
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.
- The Specificity of GERDQ for Diagnosis of GERD [over 3 years]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the first affiliated hospital of SYSU | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
Investigators
- Study Director: Minhu Chen, PHD, vice-president of the first Affiliated hospital of SYSU
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
tanniandi,
Resident physician,
First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02506634
Other Study ID Numbers:
- ESR-14-10521
First Posted:
Jul 23, 2015
Last Update Posted:
Jan 13, 2020
Last Verified:
Dec 1, 2019
Keywords provided by tanniandi,
Resident physician,
First Affiliated Hospital, Sun Yat-Sen University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Patients With Upper GI Symptoms |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 374 |
| Participants Who Were Diagnosed as GERD | 154 |
| Participants Who Received PPI Treatment | 357 |
| Participants Who Finished GERDQ | 342 |
| COMPLETED | 357 |
| NOT COMPLETED | 17 |
Baseline Characteristics
| Arm/Group Title | Patients With Predominant Heartburn | Patients With Predominant Regurgitation | Patients With Predominant Chest Pain | Patients With Predominant Dysphagia | Patients With Predominant Epigastric Pain | Patients With Predominant Epigastric Burning | Patients With Predominant Postprandial Fullness | Patients With Predominant Early Satiety | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 87 | 82 | 63 | 12 | 35 | 29 | 64 | 2 | 374 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
46.90
(12.25)
|
40.96
(14.06)
|
43.27
(10.70)
|
41.83
(13.29)
|
42.54
(14.56)
|
43.83
(14.34)
|
39.88
(13.31)
|
30.50
(12.02)
|
42.88
(12.31)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
42
48.3%
|
40
48.8%
|
32
50.8%
|
7
58.3%
|
24
68.6%
|
18
62.1%
|
31
48.4%
|
2
100%
|
196
52.4%
|
| Male |
45
51.7%
|
42
51.2%
|
31
49.2%
|
5
41.7%
|
11
31.4%
|
11
37.9%
|
33
51.6%
|
0
0%
|
178
47.6%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||||||||
| Count of Participants [Participants] |
0
0%
|
||||||||
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [kg/m^2] |
22.22
(3.21)
|
22.07
(3.17)
|
22.69
(3.42)
|
21.20
(3.22)
|
21.95
(3.31)
|
22.78
(3.05)
|
21.39
(2.81)
|
17.98
(1.12)
|
22.09
(3.15)
|
Outcome Measures
| Title | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department |
|---|---|
| Description | 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. |
| Time Frame | over 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GERD Patients Defined by Reflux Esophagitis on Endoscopy | GERD Patients Defined by Positive AET on Reflux Monitoring | GERD Patients Defined by Either Endoscopy or Reflux Monitoring |
|---|---|---|---|
| Arm/Group Description | The percentage of GERD patients with different predominant symptom will be calculated. | The percentage of GERD patients with different predominant symptom will be calculated. | The percentage of GERD patients with different predominant symptom will be calculated. |
| Measure Participants | 79 | 111 | 154 |
| Heartburn |
19
21.8%
|
30
36.6%
|
42
66.7%
|
| Regurgitation |
23
26.4%
|
30
36.6%
|
38
60.3%
|
| Chest pain |
9
10.3%
|
16
19.5%
|
23
36.5%
|
| Dysphagia |
2
2.3%
|
4
4.9%
|
4
6.3%
|
| Epigastric pain |
9
10.3%
|
5
6.1%
|
11
17.5%
|
| Epigastric burning |
4
4.6%
|
11
13.4%
|
13
20.6%
|
| Postprandial fullness |
13
14.9%
|
15
18.3%
|
23
36.5%
|
| Early satiety |
0
0%
|
0
0%
|
0
0%
|
| Title | The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms |
|---|---|
| Description | 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. |
| Time Frame | over 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Among 374 enrolled patients presented with different main symptom, the percentage of patients with reflux esophagitis was calculated. |
| Arm/Group Title | Patients With Predominant Heartburn | Patients With Predominant Regurgitation | Patients With Predominant Chest Pain | Patients With Predominant Dysphagia | Patients With Predominant Epigastric Pain | Patients With Predominant Epigastric Burning | Patients With Predominant Postprandial Fullness | Patients With Predominant Early Satiety |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant heartburn will be calculated. | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant regurgitation will be calculated. | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant chest pain will be calculated. | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant dysphagia will be calculated. | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant epigastric pain will be calculated. | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant epigastric burning will be calculated. | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant postprandial fullness will be calculated. | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with predominant early satiety will be calculated. |
| Measure Participants | 87 | 82 | 63 | 12 | 35 | 29 | 64 | 2 |
| Count of Participants [Participants] |
19
21.8%
|
23
28%
|
9
14.3%
|
2
16.7%
|
9
25.7%
|
4
13.8%
|
13
20.3%
|
0
0%
|
| Title | The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms |
|---|---|
| Description | 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. |
| Time Frame | over 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Among 374 enrolled patients presented with different main symptom, the percentage of patients with pathological acid reflux was calculated. |
| Arm/Group Title | Patients With Predominant Heartburn | Patients With Predominant Regurgitation | Patients With Predominant Chest Pain | Patients With Predominant Dysphagia | Patients With Predominant Epigastric Pain | Patients With Predominant Epigastric Burning | Patients With Predominant Postprandial Fullness | Patients With Predominant Early Satiety |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant heartburn will be calculated. | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant regurgitation will be calculated. | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant chest pain will be calculated. | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant dysphagia will be calculated. | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant epigastric pain will be calculated. | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant epigastric burning will be calculated. | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant postprandial fullness will be calculated. | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with predominant early satiety will be calculated. |
| Measure Participants | 87 | 82 | 63 | 12 | 35 | 29 | 64 | 2 |
| Count of Participants [Participants] |
30
34.5%
|
30
36.6%
|
16
25.4%
|
4
33.3%
|
5
14.3%
|
11
37.9%
|
15
23.4%
|
0
0%
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | over 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GERD Patients With Predominant Heartburn | GERD Patients With Predominant Regurgitation | GERD Patients With Predominant Chest Pain | GERD Patients With Predominant Dysphagia | GERD Patients With Predominant Epigastric Pain | GERD Patients With Predominant Epigastric Burning | GERD Patients With Predominant Postprandial Fullness | GERD Patients With Predominant Early Satiety |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | The life quality of GERD patients with predominant heartburn will be measured via the MOS 36-item short form health survey (SF-36). | The life quality of GERD patients with predominant regurgitation will be measured via the MOS 36-item short form health survey (SF-36). | The life quality of GERD patients with predominant chest pain will be measured via the MOS 36-item short form health survey (SF-36). | The life quality of GERD patients with predominant dysphagia will be measured via the MOS 36-item short form health survey (SF-36). | The life quality of GERD patients with predominant epigastric pain will be measured via the MOS 36-item short form health survey (SF-36). | The life quality of GERD patients with predominant epigastric burning will be measured via the MOS 36-item short form health survey (SF-36). | The life quality of GERD patients with predominant postprandial fullness will be measured via the MOS 36-item short form health survey (SF-36). | The life quality of GERD patients with predominant early satiety will be measured via the MOS 36-item short form health survey (SF-36). |
| Measure Participants | 42 | 38 | 23 | 4 | 11 | 13 | 23 | 0 |
| Mean (Standard Deviation) [score on a scale] |
565.04
(163.59)
|
582.55
(128.87)
|
606.35
(134.44)
|
706.67
(18.35)
|
581.15
(193.52)
|
545.8
(176.79)
|
618.18
(152.35)
|
| Title | The Sensitivity of PPI Test for Diagnosis of GERD |
|---|---|
| Description | 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. |
| Time Frame | over 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Patients With Typical Reflux Symptoms | Patients With Atypical Symptoms |
|---|---|---|
| Arm/Group Description | The sensitivity of PPI test for the diagnosis of GERD in patients with typical reflux symptoms will be calculated. | The sensitivity of PPI test for the diagnosis of GERD in patients with atypical reflux symptoms will be calculated. |
| Measure Participants | 160 | 197 |
| Number [Percentage of true positive] |
0.64
|
0.51
|
| Title | The Specificity of PPI Test for Diagnosis of GERD |
|---|---|
| Description | 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. |
| Time Frame | over 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Patients With Typical Reflux Symptoms | Patients With Atypical Symptoms |
|---|---|---|
| Arm/Group Description | The specificity of PPI test for the diagnosis of GERD in patients with typical reflux symptoms will be calculated. | The specificity of PPI test for the diagnosis of GERD in patients with atypical reflux symptoms will be calculated. |
| Measure Participants | 160 | 197 |
| Number [Percentage of true negative] |
0.40
|
0.62
|
| Title | The Sensitivity of GERDQ for Diagnosis of GERD |
|---|---|
| Description | 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. |
| Time Frame | over 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Patients With Typical Reflux Symptoms | Patients With Atypical Symptoms |
|---|---|---|
| Arm/Group Description | The sensitivity of GERDQ for the diagnosis of GERD in patients with typical reflux symptoms will be calculated. | The sensitivity of GERDQ for the diagnosis of GERD in patients with atypical reflux symptoms will be calculated. |
| Measure Participants | 153 | 189 |
| Number [Percentage of true positive] |
0.84
|
0.43
|
| Title | The Specificity of GERDQ for Diagnosis of GERD |
|---|---|
| Description | 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. |
| Time Frame | over 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Patients With Typical Reflux Symptoms | Patients With Atypical Symptoms |
|---|---|---|
| Arm/Group Description | The specificity of GERDQ for the diagnosis of GERD in patients with typical reflux symptoms will be calculated. | The specificity of GERDQ for the diagnosis of GERD in patients with atypical reflux symptoms will be calculated. |
| Measure Participants | 153 | 189 |
| Number [Percentage of true negative] |
0.24
|
0.63
|
Adverse Events
| Time Frame | over 3 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Patients Who Received PPI Treatment | |
| Arm/Group Description | The frequency of adverse events among patients who received PPI treatment was calculated. | |
All Cause Mortality |
||
| Patients Who Received PPI Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/357 (0%) | |
Serious Adverse Events |
||
| Patients Who Received PPI Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/357 (0.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Pneumothorax | 1/357 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Patients Who Received PPI Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 42/357 (11.8%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 11/357 (3.1%) | |
| Abdominal distension | 10/357 (2.8%) | |
| Diarrhea | 9/357 (2.5%) | |
| Bitter taste | 5/357 (1.4%) | |
| Nausea | 5/357 (1.4%) | |
| General disorders | ||
| Fatigue | 6/357 (1.7%) | |
| Headache | 4/357 (1.1%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Niandi Tan |
|---|---|
| Organization | FirstSunYetSen |
| Phone | +86 15989117039 |
| tanniandi@126.com |
Responsible Party:
tanniandi,
Resident physician,
First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02506634
Other Study ID Numbers:
- ESR-14-10521
First Posted:
Jul 23, 2015
Last Update Posted:
Jan 13, 2020
Last Verified:
Dec 1, 2019