Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03223116
• Other study ID #: CC2015
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2017
• Last updated: July 18, 2017
• Start date: July 1, 2015
• Est. completion date: July 1, 2018

Study information

• Verified date: July 2017
• Source: Changhai Hospital
• Contact: luowei Wang, MD
• Phone: 13901833088
• Email: wangluoweimd[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2018
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• Radiofrequency delivery
Radiofrequency to the gastroesophageal junction

Locations

Country	Name	City	State
China	Departmentof Gastroenterology Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline esophagitis grade at 12 months	Assess the esophagitis condition at 12 month and compare it with the baseline	12 months
Secondary	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
Secondary	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
Secondary	Change from baseline medication at 12 months	Assess dosage of the medication at 12 month and compare it with the baseline	12 months