Back to resultsRadiofrequency Energy Delivery for Gastroesophageal Reflux Disease
Primary Purpose
Gastroesophageal Reflux Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radiofrequency delivery
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring heartburn, regurgitation
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.
Sites / Locations
- Departmentof Gastroenterology Changhai HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiofrequency
Arm Description
Radiofrequency delivery to the gastroesophageal junction
Outcomes
Primary Outcome Measures
Change from Baseline GERD-HRQL scores at 12 months
Assess the GERD-HRQL scores at 12 month and compare it with the baseline
Secondary Outcome Measures
Change from baseline esophagitis grade at 12 months
Assess the esophagitis condition at 12 month and compare it with the baseline
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
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
Change from baseline medication at 12 months
Assess dosage of the medication at 12 month and compare it with the baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03223116
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
September 1, 2017 (Anticipated)
Study Completion Date
July 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
heartburn, regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency
Arm Type
Experimental
Arm Description
Radiofrequency delivery to the gastroesophageal junction
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency delivery
Intervention Description
Radiofrequency to the gastroesophageal junction
Primary Outcome Measure Information:
Title
Change from Baseline GERD-HRQL scores at 12 months
Description
Assess the GERD-HRQL scores at 12 month and compare it with the baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline esophagitis grade at 12 months
Description
Assess the esophagitis condition at 12 month and compare it with the baseline
Time Frame
12 months
Title
Change from baseline esophageal acid exposure times from at 12 months
Description
Measure the esophageal acid exposure at 12 months and compare it with the baseline
Time Frame
12 month
Title
Change from baseline lower esophageal sphincter pressure at 12 months
Description
Measure the lower esophageal sphincter pressure at 12 month and compare it with the baseline
Time Frame
12 month
Title
Change from baseline medication at 12 months
Description
Assess dosage of the medication at 12 month and compare it with the baseline
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
luowei Wang, MD
Phone
13901833088
Email
wangluoweimd@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
peipei Liu, MD
Phone
15821692703
Email
15821692703@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhaoshen Li, MD
Organizational Affiliation
Changhai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Departmentof Gastroenterology Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
luowei Wang, MD
Phone
13901833088
Email
wangluoweimd@126.com
First Name & Middle Initial & Last Name & Degree
peipei Liu
Phone
15821692703
Email
15821692703@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27261337
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.
Results Reference
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Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease
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