the Efficency and Safety of Stretta in GERD

Study Overview
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Brief Summary
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This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients.

Detailed Description
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Gastro-esophageal reflux disease (GERD) is the most common outpatient diagnosis in gastroenterology and is associated with a significant burden on the healthcare system. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment,howerver, some patients have an unsatisfactory response to high doses of PPIs, which remains a challenge. The Stretta procedure, a radiofrequency (RF) application to the lower esophageal sphincter (LES), was introduced about 15 years ago as an alternative to chronic medical therapy or surgical intervention for GERD.The Stretta procedure appears to result in thickening of the LES, decreased transient LES relaxation rate and reduced esophageal acid exposure.The majority studies of Stretta were held in USA and Europe, the sduty of Stretta in Asia is rare. The investigators propose to perform a prospectively observiton study to evaluate the efficency of the Stretta procedure in patients of refractory GERD in China.

Official Title
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the Efficency and Safety of the Endoscopic Radiofrequency Procedure in Gastroesophageal Reflux Diseases

Conditions
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GERD, Radiofrequency Ablation

Intervention / Treatment
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* Device: Stretta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Small hiatus hernia (< 2-3 cm) Los Angeles Grade 'A' or 'B' Reflux Esophagitis or non erosive esophagitis LES pressure <15 mm Hg PPI dependent / refractory GERD abnormal 24h esophagus pH-impedance monitoring Exclusion Criteria: Age < 18 years Large hiatus hernia (> 3 cm) Los Angeles Grade 'C' or 'D' Reflux Esophagitis LES pressure > 15 mm Hg Underlying coagulation disorder Previous Esophageal or Gastric surgery Pregnant major esophagus motility disorder according to Chicago v3.0

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stretta<br>Radio Frequency Ablation (RFA) using a Stretta device. | Device: Stretta<br>* Stretta<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD-HRQL scores | the improvement of GERD-HRQL scores after procedure.Scale ranges 0-50 points, the lower score means the better efficacy. | [Time Frame: Change from Baseline HRQL scores at 1 month;Change from Baseline HRQL scores at 2 months;Change from Baseline HRQL scores at 6 months;Change from Baseline HRQL scores at 1 year] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure | Questionnaire will be provided to each participant to report no further requirement of PPI drug post procedure. | Change from Baseline number at 1 month;Change from Baseline number at 2 months;Change from Baseline number at 6 months;Change from Baseline number at 1 year] | 
| Demeester Score | the change of Demeester scores after procedure. The lower, the better. | 1 year | 
| LES Pressure | the change of LES pressure after procedure.The higher, the better. | 1 year | 
| Number of participants with treatment-related adverse events | Number of participants with treatment-related adverse events | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Radiofrequency ablation, efficiency, safety