the Efficency and Safety of Stretta in GERD

• Conditions: Radiofrequency Ablation; GERD
• Interventions: Device: Stretta

• Registration Number: NCT03574831
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study Start: 2016-01-02
• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-06-29
• Status Verified: 2018-07
• Study First Posted: 2018-07-02
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-13
• Primary Completion: 2020-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stretta	Stretta	Radio Frequency Ablation (RFA) using a Stretta device.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gastroenterology department,Beijing Tong Ren Hospital, Capital Medical University.; 🇨🇳 Beijing, Beijing, China