The Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department

Gastroesophageal Reflux Clinical Trial

Official title:

The Primary Symptoms of GERD in Chinese Outpatients in Gastroenterology Department: A Cross-sectional Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506634
• Other study ID #: ESR-14-10521
• Status: Completed
• Start date: August 2015
• Est. completion date: January 2019

Study information

• Verified date: December 2019
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux

Intervention

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.

Locations

Country	Name	City	State
China	the first affiliated hospital of SYSU	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	over 3 years
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.	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.	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.	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.	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.	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.	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.	over 3 years