Clinical trial NCT03574831: the Efficency and Safety of Stretta in GERD
Official title: the Efficency and Safety of the Endoscopic Radiofrequency Procedure in Gastroesophageal Reflux Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: GERD
Radiofrequency Ablation
Keywords: GERD
Radiofrequency ablation
efficiency
safety
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with refractory GERD symptoms, without major esophagus motility disorder and large hiatus hernia.

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.

Eligibility criteria: 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

Primary outcomes:
measure: GERD-HRQL scores
timeFrame: [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 outcomes:
measure: Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure
timeFrame: 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]
measure: Demeester Score
timeFrame: 1 year
measure: LES Pressure
timeFrame: 1 year
measure: Number of participants with treatment-related adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gastroenterology department,Beijing Tong Ren Hospital, Capital Medical University.
state: Beijing
Study officials:
affiliation: Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University
name: Chuan Zhang, MD
role: STUDY_CHAIR
References: