Gastroesophageal Reflux Disease
Conditions
Keywords
heartburn, regurgitation
Brief summary
This study is to evaluate the safety and efficacy of radiofrequency energy procedure for Gastro-esophageal reflux disease (GERD) based on changes of symptoms, medication esophagitis grade, esophageal acid exposure and lower esophageal sphincter pressure. Symptom assessment was performed at baseline and 3, 6, 12 months after treatment.
Detailed description
Gastroesophageal reflux disease (GERD) is a chronic disease characterized by symptoms of heartburn and acid regurgitation. Uncontrolled GERD can significantly impact quality of life. The use of proton pump inhibitors (PPI) remains the mainstay therapy. However, the efficacy of this intervention is often hampered by adherence, costs, and the risks of long-term PPI use. Anti-reflux surgery is an option for patients with refractory symptoms or in those in whom medical therapy is contraindicated or not desirable, but the incidence of dysphagia, abdominal distension associated wth the surgery is high. Radiofrequency ablation, minimally invasive, less complications, has become alternative treatments options. But the current research on radiofrequency treatment of the data is limited in China. Therefore, the investigators conduct this multi-center clinical trial.
Interventions
PROCEDURERadiofrequency delivery
Radiofrequency to the gastroesophageal junction
Sponsors
Changhai Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 18 years or older * diagnosis of GERD established by either * 24-h oesophageal pH monitoring (performed off medications) showing an abnormal OAE (pH \< 4 at least 4% of time) and/or * an upper gastrointestinal (GI) endoscopy showing oesophagitis grade A or B in Los Angeles (LA) classification * presence of typical symptoms of GERD (heartburn and ⁄or regurgitation with at least three episodes of typical symptoms per week in the absence of PPI therapy), * adequate symptom relief obtained with PPIs,but needing maintenance with at least standard dose.
Exclusion criteria
* presence of Barrett's oesophagus \>3 cm and ⁄or with dysplasia and ⁄or previously treated, * presence of hiatus hernia \>3 cm, * presence of oesophagitis grade C or D in LA classification, * presence of oesophageal stricture or achalasia, * history of oesophageal or gastric surgery, * presence of gastric or oesophageal varices, * impossibility to stop an anticoagulant therapy or severe coagulopathy, * any contraindication to general anaesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline GERD-HRQL scores at 12 months | 12 months | Assess the GERD-HRQL scores at 12 month and compare it with the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline esophagitis grade at 12 months | 12 months | Assess the esophagitis condition at 12 month and compare it with the baseline |
| Change from baseline esophageal acid exposure times from at 12 months | 12 month | Measure the esophageal acid exposure at 12 months and compare it with the baseline |
| Change from baseline lower esophageal sphincter pressure at 12 months | 12 month | Measure the lower esophageal sphincter pressure at 12 month and compare it with the baseline |
| Change from baseline medication at 12 months | 12 months | Assess dosage of the medication at 12 month and compare it with the baseline |
Countries
China
Contacts
Primary Contactluowei Wang, MD
Backup Contactpeipei Liu, MD
Outcome results
None listed