refractory gastroesophageal reflux disease
Conditions
Interventions
Case series:trans-oral incisionless fundoplication (TIF) by the Muse endoscope
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Recently (within 30 days), PPI was stopped for more than 7 days and GERD was confirmed by pH monitoring; 3. Have heartburn for at least one year; 4. After PPI treatment for at least 6 months, the symptoms were obviously relieved. When PPI was stopped, there was obvious gastroesophageal reflux; 5. Esophageal manometry within 30 days showed sufficient esophageal peristalsis; 6. Patients understand the research requirements and treatment procedures, and sign the informed consent form (ICF) before the start of the study; 7. Willing to comply with all follow-up assessments; 8. Be able to read and sign ICF.
Exclusion criteria
Exclusion criteria: 1. Endoscopic findings of esophageal hiatal hernia > 2cm or any size irreducible hiatal hernia; 2. The results of acid exposure test were normal (total time of pH 35; 11. Helicobacter pylori test positive - can be included after radical treatment; 12. Have the following medical history: (1) any heart disease, NYHA cardiac function classification >1; (2) either of the two types of diabetes; (3) endocrine disorders (except hypothyroidism under drug treatment); (4) history of epilepsy, stroke, Parkinson's disease, muscular atrophy such as ALS or multiple sclerosis; (5) soft tissue conditions that affect wound healing (e.g., amyloidosis); (6) history of esophagogastric surgery (except for pyloromyotomy in childhood); (7) Portal hypertension caused by cirrhosis or other causes; (8) autoimmune diseases (SLE, scleroderma, dermatomyositis); (9) renal failure (serum creatinine >=1.6); (10) blood disease, or taking anticoagulant drugs (heparin, excluding aspirin), aspirin stopped 7 days before the beginning of treatment, and recovered after discharge; (11) any type of cancer, except skin cancer, was not actively treated; (12) have gastric or duodenal ulcer; 13. Pregnancy; 14. Any medical factors that the researcher believes will cause the patient to be unable to complete the study; 15. Alcohol and drug abuse within six months; 16. Patients who participated in or prepared to participate in other drug or device trials within the last 30 days or during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of reflux symptoms; | — |
Countries
China
Contacts
Public ContactWan Rong
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed