Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease

Changhai Hospital150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Gastroesophageal Reflux Disease

Interventions

Radiofrequency deliveryPROCEDURE

Radiofrequency to the gastroesophageal junction

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Departmentof Gastroenterology Changhai Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline GERD-HRQL scores at 12 months

Assess the GERD-HRQL scores at 12 month and compare it with the baseline

Time frame: 12 months

Secondary Outcomes

Change from baseline esophagitis grade at 12 months

Assess the esophagitis condition at 12 month and compare it with the baseline

Time frame: 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

Time frame: 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

Time frame: 12 month

Change from baseline medication at 12 months

Assess dosage of the medication at 12 month and compare it with the baseline

Time frame: 12 months

Central Contacts

luowei Wang, MD

CONTACT

13901833088 wangluoweimd@126.com

peipei Liu, MD

CONTACT

15821692703 15821692703@163.com

Data from ClinicalTrials.gov

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