Stretta Versus Conservative Treatment in Obese and Non-obese
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Obese patients receiving Stretta
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Procedure: Radiofrequency Energy to the LES (Stretta Procedure)
The Stretta procedure is performed endoscopically under general anesthesia which uses radiofrequency (RF) energy delivered to the lower esophageal sphincter and cardia.
Device: Stretta
Stretta is a FDA approved device for the management of GERD.
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No Intervention: Obese patients receiving Conservative therapy/PPI
|
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Active Comparator: Non-obese patients receiving Stretta
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Procedure: Radiofrequency Energy to the LES (Stretta Procedure)
The Stretta procedure is performed endoscopically under general anesthesia which uses radiofrequency (RF) energy delivered to the lower esophageal sphincter and cardia.
Device: Stretta
Stretta is a FDA approved device for the management of GERD.
|
No Intervention: Non-obese patients receiving Conservative treatment/PPI
|
Outcome Measures
Primary Outcome Measures
- PPI usage [6 and12 months]
Stopping PPI use or reducing PPI dose by more than 50 % in patients
- GERD Health Related Quality of Life (GERD-HRQL) questionaire [6 and 12 months]
Achievement at least a 50 % reduction in symptoms during the initial 12 month as compared to baseline
- Reflux Severity Index (RSI) score [6 and12 months]
Achievement at least a 50 % reduction in symptoms during the initial 12 month as compared to baseline
Secondary Outcome Measures
- 24h pH-metry with impedance [6 and 12 months]
Achievment at least a 50 % reduction in pH-metric parameters (Acid Exposure Time - AET)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Verified symptomatic GERD using PPI but with persistent symptoms or like to discontinue or are intolerant to them
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Positive 24h pH-metry for pathological GE reflux
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Normal finding on HR esophageal manometry according to CCv4.0
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Age over 18
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Signed informed consent with the trial and invasive procedures
Exclusion Criteria:
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Active severe reflux esophagitis (LA classification grade C - D)
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Barrett's esophagus
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Esophageal peptic stricture, eosinophilic esophagitis
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Hiatal hernia more than 2 cm
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Malignancies
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Abnormal HR esophageal manometry
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Esophageal and subcardial varices
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Pregnancy
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Severe comorbidities and increased perioperative risk
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Military University Hospital Prague | Prague | Czechia |
Sponsors and Collaborators
- Military University Hospital, Prague
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 108/17-12/2022