STRETTA ,Radio Frequency Ablation (RFA) v/s Sham Therapy for the Treatment of Refractory GERD

Study Overview
=================
Brief Summary
-----------------
Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.

Detailed Description
-----------------
Gastro-esophageal reflux disease (GERD) is a chronic disorder with significant impact on the quality of life of patients. It may also lead to several complications like peptic strictures, ulcerations, Barrett 's disease and subsequently adenocarcinoma of the esophagus. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment, with up to 90 % of patients with reflux disease becoming asymptomatic while taking PPIs. However, the treatment of patients with proven GERD, who have an unsatisfactory response to high doses of PPIs remains a challenge. A number of endoscopic procedures, aimed at improvement of the barrier function of the lower esophageal sphincter (LES), have emerged over the last decade. Several studies have demonstrated that RF delivery at the gastro-esophageal junction(GEJ), also called the Stretta procedure, induces symptom relief and decreases need of PPI intake in GERD. The investigators propose to perform a sham-controlled randomized study to evaluate the influence of the Stretta procedure on symptoms and esophageal acid exposure in patients of refractory GERD.

Official Title
-----------------
A Prospective Randomized Trial Comparing Endoscopic Radio Frequency Ablation (RFA) - STRETTA vs Sham Therapy for the Treatment of Refractory Gastroesophageal Reflux Disease

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Device: Radio Frequency Ablation (RFA) (Stretta Procedure)
* Procedure: Sham Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18years Small hiatus hernia (< 2-3 cm) Los Angeles Grade 'A' or 'B' Reflux Esophagitis LES pressure : 5 - 15 mm Hg PPI dependent / refractory GERD 24 hr acid exposure study showing abnormal esophageal acid exposure > 4% DeMeester Score >14.7 Esophageal manometry showing normal peristalsis Exclusion Criteria Age < 18 years Large hiatus hernia (> 3 cm) Los Angeles Grade 'C' or 'D' Reflux Esophagitis LES pressure : < 5 or > 15 mm Hg Underlying coagulation disorder Previous Esophageal or Gastric surgery H/o coronary artery disease (CAD) Esophageal manometry showing ineffective peristalsis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RFA (Stretta Procedure)<br>Radio Frequency Ablation (RFA) using a Stretta device. | Device: Radio Frequency Ablation (RFA) (Stretta Procedure)<br>* Radio Frequency Ablation (RFA) for the treatment of refractory gastroesophageal reflux disease.<br>|
| Sham Comparator: Placebo Arm<br>Stretta device used but RFA will not be generated. | Procedure: Sham Procedure<br>* Stretta device will be used but Radio Frequency Ablation (RFA) will not be generated.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who report improvement in Quality of Life (QOL) post Stretta procedure as compared to Sham therapy. | 6 point GERD Likert Scale will be used to assess the improvement in frequency and severity of GERD symptoms post Stretta procedure & Sham therapy amongst patients. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure as compared to Sham therapy. | Questionnaire will be provided to each participant to report no further requirement of PPI drug post procedure. | 1 year | 
| Comparison of Increased Lower Esophageal Sphincter pressure among patients post Stretta procedure & Sham Therapy. | High Resolution Esophageal Manometry will be performed after the procedure in each patient to compare the LES pressure between the two groups. | 1 year |