gastroesophageal reflux disease
Conditions
Interventions
MUSE:Endoscopic fundoplication by MUSE
Sponsors
Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old; 2. PH monitoring confirmed GERD and PPI is discontinued within 30 days; 3. Have heartburn symptom for at least two years; 4. On PPI treatment for at least 6 months, the GERD symptoms are significantly relieved; when PPI is discontinued, symptoms relapse; 5. Esophageal manometry within 30 days showed sufficient esophageal peristalsis without motor dysfunction; 6. Patients understand the study requirements and treatment procedures and sign an informed consent form (ICF) before the study begins; 7. Follow all follow-up evaluations; 8. In good health except GERD; 9. Be able to read and sign ICF.
Exclusion criteria
Exclusion criteria: 1. Esophageal hiatal hernia >3cm or any size of irreversible esophageal hiatal hernia; 2. The acid exposure test is normal (total time of pH35; 11. Helicobacter pylori test positive-can be included after cure; 12. Have the following medical history: (1) Any type of heart disease, NYHA cardiac function grade>1; (2) Both types of diabetes; (3) Endocrine disorders (except hypothyroidism that is being controlled by medicine); (4) History of epilepsy, stroke, Parkinson's disease, muscular dystrophy diseases such as ALS or multiple sclerosis; (5) Soft tissue conditions that affect wound healing (such as amyloidosis); (6) Esophagus/stomach history of surgery (except childhood pylorotomy); (7) Portal hypertension due to cirrhosis or other causes; (8) Autoimmune diseases (SLE, scleroderma, dermatomyositis); (9) Renal failure (blood creatinine >=1.6); (10) Blood disease, or taking anticoagulant drugs (heparin, excluding aspirin), aspirin stopped 7 days before the course of treatment, recoverable after discharge; (11) Any type of cancer, except skin cancer, the patient has not received active treatment; (12) Suffer stomach or duodenal ulcers; 13. Any recent history of unintentional weight loss; 14. Pregnancy; 15. Any medical factors that the investigator believes will prevent the patient from completing the study; 16. History of alcohol and drug abuse within six months; 17. Patients who participated in or plan to participate in other drug trials or device trials in the last 30 days or during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of GERD health-related quality of life (HRQL) reduction >=50%; | — |
Secondary
| Measure | Time frame |
|---|---|
| GERD questionnaire (GERD-Q);Total time with pH <4;Off PPI;Gastroesophageal flap valve (GEFV) grading system (Hill grade);Number of episodes of pH <4 longer than 5 min;Lower esophageal sphincter (LES) pressure;Adverse effects; | — |
Countries
China
Contacts
Public ContactYang, Yunsheng
Department of Gastroenterology and Hepatology, The First Medical Center, Chinese PLA General Hospital
Outcome results
None listed