the Efficency and Safety of Stretta in GERD

Capital Medical University60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

GERD Radiofrequency Ablation

Interventions

StrettaDEVICE

Stretta

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Gastroenterology department,Beijing Tong Ren Hospital, Capital Medical University.

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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: [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

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.

Time frame: 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.

Time frame: 1 year

LES Pressure

the change of LES pressure after procedure.The higher, the better.

Time frame: 1 year

Number of participants with treatment-related adverse events

Time frame: 1 month

Central Contacts

Hao Zi Guo, MD

CONTACT

86+15801227696 zihaoguo@139.com

Data from ClinicalTrials.gov

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