Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease

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

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.

Study Overview

• Status: Unknown
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Procedure: Radiofrequency delivery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Departmentof Gastroenterology Changhai Hospital
      • Contact: Luowei Wang, MD; Phone Number: 13901833088; Email: wangluoweimd@126.com
      • Contact: peipei Liu; Phone Number: 15821692703; Email: 15821692703@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency; Radiofrequency delivery to the gastroesophageal junction	Procedure: Radiofrequency delivery; Radiofrequency to the gastroesophageal junction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Study Chair: Zhaoshen Li, MD, Changhai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: heartburn; regurgitation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: CC2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No