GERD, Radiofrequency Ablation
Conditions
Keywords
GERD, Radiofrequency ablation, efficiency, safety
Brief summary
This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients.
Detailed description
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.
Interventions
DEVICEStretta
Stretta
Sponsors
Capital Medical University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years 2. Small hiatus hernia (\< 2-3 cm) 3. Los Angeles Grade 'A' or 'B' Reflux Esophagitis or non erosive esophagitis 4. LES pressure \<15 mm Hg 5. PPI dependent / refractory GERD 6. abnormal 24h esophagus pH-impedance monitoring
Exclusion criteria
1. Age \< 18 years 2. Large hiatus hernia (\> 3 cm) 3. Los Angeles Grade 'C' or 'D' Reflux Esophagitis 4. LES pressure \> 15 mm Hg 5. Underlying coagulation disorder 6. Previous Esophageal or Gastric surgery 7. Pregnant 8. major esophagus motility disorder according to Chicago v3.0
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GERD-HRQL scores | [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] | the improvement of GERD-HRQL scores after procedure.Scale ranges 0-50 points, the lower score means the better efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta 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] | Questionnaire will be provided to each participant to report no further requirement of PPI drug post procedure. |
| Demeester Score | 1 year | the change of Demeester scores after procedure. The lower, the better. |
| LES Pressure | 1 year | the change of LES pressure after procedure.The higher, the better. |
| Number of participants with treatment-related adverse events | 1 month | Number of participants with treatment-related adverse events |
Countries
China
Contacts
Primary ContactHao Zi Guo, MD
Outcome results
None listed