Stretta Versus Conservative Treatment in Obese and Non-obese

Study Overview
=================
Brief Summary
-----------------
Gastroesophageal reflux disease (GERD) is one of the most common diseases of the gastrointestinal tract. One of the main risk factor is obesity. Currently, either conservative treatment including pharmacotherapy and lifestyle modifications or surgical treatment are the only therapeutic options available in the Czech Republic, both approaches having their known limitations. Stretta is a minimally invasive endoscopic therapy using the radiofrequency energy delivered to the EGJ and cardia to eventually enhance the antireflux barrier. This study will attempt to get information regarding the treatment of GERD using Stretta in the Czech Republic and correlate results in obese and non-obese population.

Official Title
-----------------
Endoscopic Treatment of Gastro-esophageal Reflux Disease With Application of Radiofrequency Energy to the Lower Esophageal Sphincter (Stretta) Versus Conservative Treatment in Obese and Non-obese Population, Prospective Randomized Study

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

Intervention / Treatment
-----------------
* Procedure: Radiofrequency Energy to the LES (Stretta Procedure)
* Device: Stretta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Verified symptomatic GERD using PPI but with persistent symptoms or like to discontinue or are intolerant to them Positive 24h pH-metry for pathological GE reflux Normal finding on HR esophageal manometry according to CCv4.0 Age over 18 Signed informed consent with the trial and invasive procedures Exclusion Criteria: Active severe reflux esophagitis (LA classification grade C - D) Barrett's esophagus Esophageal peptic stricture, eosinophilic esophagitis Hiatal hernia more than 2 cm Malignancies Abnormal HR esophageal manometry Esophageal and subcardial varices Pregnancy Severe comorbidities and increased perioperative risk

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Interventional Model Description: Patients will be devided into 2 groups (obese and non-obese). Each group will be randomized (ratio 1:1) into 2 subgroups receiving the therapy (Stretta : Conservative/PPI)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Obese patients receiving Stretta<br> | Procedure: Radiofrequency Energy to the LES (Stretta Procedure)<br>* The Stretta procedure is performed endoscopically under general anesthesia which uses radiofrequency (RF) energy delivered to the lower esophageal sphincter and cardia.<br>Device: Stretta<br>* Stretta is a FDA approved device for the management of GERD.<br>|
| No Intervention: Obese patients receiving Conservative therapy/PPI<br> | |
| Active Comparator: Non-obese patients receiving Stretta<br> | Procedure: Radiofrequency Energy to the LES (Stretta Procedure)<br>* The Stretta procedure is performed endoscopically under general anesthesia which uses radiofrequency (RF) energy delivered to the lower esophageal sphincter and cardia.<br>Device: Stretta<br>* Stretta is a FDA approved device for the management of GERD.<br>|
| No Intervention: Non-obese patients receiving Conservative treatment/PPI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proton pump inhibitors (PPI) use | Cessation or reducing the dose of PPI by at least 50% from baseline | 6 months | 
| Proton pump inhibitors (PPI) use | Cessation or reducing the dose of PPI by at least 50% from baseline | 12 months | 
| GERD Health Related Quality of Life questionaire | Change in symptom severity assessed by validated reflux questionnaire | 6 months | 
| GERD Health Related Quality of Life questionaire | Change in symptom severity assessed by validated reflux questionnaire (GERD - HRQL) | 12 months | 
| Reflux Severity Index score | Change in symptom severity assessed by validated reflux questionnaire | 6 months | 
| Reflux Severity Index score | Change in symptom severity assessed by validated reflux questionnaire | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24h pH-metry with impedance | Change in pH-metric parameters (Acid Exposure Time - AET) | 6 months | 
| 24h pH-metry with impedance | Change in pH-metric parameters (Acid Exposure Time - AET) | 12 months | 
| EndoFlip - distensibility of EG junction | Change in EG junction distensibility | 3 months | 
| EndoFlip - distensibility of EG junction | Change in EG junction distensibility | 12 months |