Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease

Naval Military Medical University

Status: Unknown

Conditions: Gastroesophageal Reflux Disease

Treatments: Procedure: Radiofrequency delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT03223116

CC2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Radiofrequency

Experimental group

Description:

Radiofrequency delivery to the gastroesophageal junction

Treatment:

Procedure: Radiofrequency delivery