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This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stretta | Radio Frequency Ablation (RFA) using a Stretta device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stretta | Device | Stretta |
|
| 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] |
| 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] |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with refractory GERD symptoms, without major esophagus motility disorder and large hiatus hernia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Zi Guo, MD | Contact | 86+15801227696 | zihaoguo@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuan Zhang, MD | Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology department,Beijing Tong Ren Hospital, Capital Medical University. | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| 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 |
| D004066 | Digestive System Diseases |