Clinical trial NCT03223116: Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease
Official title: Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease: A Prospective, Multicenter Clinical Trial From China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: heartburn
regurgitation
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline GERD-HRQL scores at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline esophagitis grade at 12 months
timeFrame: 12 months
measure: Change from baseline esophageal acid exposure times from at 12 months
timeFrame: 12 month
measure: Change from baseline lower esophageal sphincter pressure at 12 months
timeFrame: 12 month
measure: Change from baseline medication at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Departmentof Gastroenterology Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: zhaoshen Li, MD
role: STUDY_CHAIR
References:
citation: Fock KM, Talley N, Goh KL, Sugano K, Katelaris P, Holtmann G, Pandolfino JE, Sharma P, Ang TL, Hongo M, Wu J, Chen M, Choi MG, Law NM, Sheu BS, Zhang J, Ho KY, Sollano J, Rani AA, Kositchaiwat C, Bhatia S. Asia-Pacific consensus on the management of gastro-oesophageal reflux disease: an update focusing on refractory reflux disease and Barrett's oesophagus. Gut. 2016 Sep;65(9):1402-15. doi: 10.1136/gutjnl-2016-311715. Epub 2016 Jun 3.