Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease: A Prospective, Multicenter Clinical Trial From China

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Procedure: Radiofrequency delivery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency<br>Radiofrequency delivery to the gastroesophageal junction | Procedure: Radiofrequency delivery<br>* Radiofrequency to the gastroesophageal junction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline GERD-HRQL scores at 12 months | Assess the GERD-HRQL scores at 12 month and compare it with the baseline | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline esophagitis grade at 12 months | Assess the esophagitis condition at 12 month and compare it with the baseline | 12 months | 
| Change from baseline esophageal acid exposure times from at 12 months | Measure the esophageal acid exposure at 12 months and compare it with the baseline | 12 month | 
| Change from baseline lower esophageal sphincter pressure at 12 months | Measure the lower esophageal sphincter pressure at 12 month and compare it with the baseline | 12 month | 
| Change from baseline medication at 12 months | Assess dosage of the medication at 12 month and compare it with the baseline | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heartburn, regurgitation