Gastoesophageal reflux disease
Conditions
Interventions
Experimental group:Anti-reflux mucosectomy with endoscopic band ligation
Sponsors
The Eighth Affiliated Hospital, Sun Yet-san University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (including 18 and 75 years), regardless of gender; 2. Patients are able to understand and comply with the requirements of the protocol and agree to participate in all study visits; 3. Voluntarily sign a written informed consent form approved by the Ethics Committee before starting any study procedures; 4. When patients present with reflux and heartburn as the main complaints, other diseases that may cause these symptoms can be excluded, and they have received at least 6 months of double-dose PPI treatment, but still have typical reflux symptoms at least twice a week; 5. Meet the GERD criteria through gastroscopy and imaging examinations; have gastroscopy results (LA standard) before ARMI surgery; 6. Pathological acid reflux is confirmed by 24-hour esophageal pH monitoring before ARMI (defined as DeMeester score > 14.7 or acid exposure time (AET) > 4.2%); 7. Hiatal hernia <= 3 cm; 8. Female patients of childbearing age agree to use appropriate medical methods of contraception throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Having participated in any other clinical studies within 3 months prior to the first administration of the study drug; 2. Suffering from Barrett's esophagus, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infections, and esophageal stricture; having a history of esophageal radiotherapy or cryotherapy; having corrosive or physicochemical trauma (such as esophageal sclerotherapy); having a large sliding hiatal hernia (> 3 cm sliding hiatal hernia, confirmed by one or more examinations including endoscopy, imaging, and manometry); 3. Having undergone anti-reflux surgery or treatment, including fundoplication, mechanical dilation for esophageal stricture, and having a history of gastric or duodenal surgery (except endoscopic resection of benign polyps); 4. Having suffered from acute upper gastrointestinal bleeding, gastric or duodenal ulcer, acute gastric mucosal injury, or duodenal mucosal injury within 30 days prior to the start of the screening period; 5. Suffering from Zollinger-Ellison syndrome or hypersecretion of gastric acid, or having a history of these conditions; 6. Subjects with "warning" symptoms suggesting possible malignant gastrointestinal lesions, such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia, except those with malignant lesions excluded by endoscopy; 7. Those who cannot tolerate gastroscopy, intubation, or have a severe tendency of blood coagulation; 8. Having allergic reactions or a history of allergies to keprazan, esomeprazole (including preparations and excipients); 9. Pregnant or lactating women; 10. Suffering from any severe liver, kidney, cardiovascular, respiratory, gastrointestinal, endocrine, hematological, central nervous system, or mental diseases, etc.; participation in the study may affect the safety of the subject or the interpretation of study results; 11. Having a history of malignant tumors within 5 years prior to screening; 12. Having any of the following abnormal laboratory test results during screening: AST > upper limit of normal, ALT > upper limit of normal, total bilirubin > upper limit of normal, creatinine > 1.5 times the upper limit of normal; 13. Subjects with clinically significant abnormal electrocardiogram (ECG), including severe arrhythmia, multifocal premature ventricular contractions (PVC), second-degree or higher atrioventricular block, etc. 14. Those who cannot cooperate to complete the study process; those who are judged by doctors as unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete symptom remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of heartburn symptoms;Vital signs;Laboratory tests;Percentage of days without heartburn;GERD-HRQL scale;GerdQ scale; | — |
Countries
China
Contacts
Public ContactChen Honglei
The Eighth Affiliated Hospital, Sun Yet-san University
Outcome results
None listed