Clinical trial NCT05781347: Stretta Versus Conservative Treatment
Official title: Endoscopic Treatment of Gastro-esophageal Reflux Disease with Application of Radiofrequency Energy to the Lower Esophageal Sphincter (Stretta) Versus Conservative Treatment, Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GERD
Lead sponsor: Military University Hospital, Prague
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized (ratio 1:1) into two groups: one receiving the Stretta therapy and the other undergoing conservative treatment with proton pump inhibitors (PPIs). The initial plan to stratify patients into obese and non-obese groups was revised due to recruitment challenges. The study now includes all eligible patients with gastroesophageal reflux disease (GERD), regardless of body weight, provided they meet the inclusion criteria.
Primary purpose: TREATMENT

Brief summary: Gastroesophageal reflux disease (GERD) is one of the most common diseases of the gastrointestinal tract. Obesity is a significant risk factor for GERD; however, treatment outcomes in obese patients remain challenging. In the Czech Republic, therapeutic options are currently limited to conservative treatment, including pharmacotherapy and lifestyle modifications, or surgical interventions, both of which have known limitations. Stretta is a minimally invasive endoscopic therapy using radiofrequency energy delivered to the esophagogastric junction (EGJ) and cardia, aimed at enhancing the antireflux barrier.

This study evaluates the effectiveness and safety of the Stretta procedure compared to conservative treatment in managing GERD. Initially designed to compare outcomes between obese and non-obese populations, the study was expanded to include all GERD patients due to recruitment challenges and the need to meet strict eligibility criteria. These criteria ensure reliable results by focusing on patients with confirmed pathological GERD while excluding those with hiatal hernias ≥ 2 cm, severe esophagitis, or functional esophageal disorders such as hypersensitivity. The study aims to provide comprehensive data on the use of Stretta in the Czech Republic and its role in GERD management.

Detailed description: Gastroesophageal reflux disease (GERD) is a significant clinical issue that substantially impairs patients' quality of life. Chronic symptoms such as heartburn, regurgitation, and chest pain, along with extraesophageal manifestations (e.g., laryngopharyngeal reflux), often drive patients-especially younger individuals-to seek effective treatment options. Many of these patients are motivated by the desire to reduce or eliminate long-term proton pump inhibitor (PPI) use, given concerns about potential side effects and dependence on medication.

The Stretta procedure, a minimally invasive endoscopic therapy using radiofrequency energy delivered to the esophagogastric junction (EGJ) and cardia, has shown promise in addressing these concerns by enhancing the antireflux barrier. This study aims to evaluate the effectiveness and safety of Stretta compared to conservative treatment in improving GERD management in the Czech Republic.

Initially, the study was designed to compare outcomes between obese and non-obese populations. However, due to recruitment challenges and the need for strict inclusion criteria, it was expanded to include all patients with confirmed pathological GERD. Participants are carefully selected based on stringent eligibility criteria, including pathological GERD confirmed by 24-hour pH-metry with impedance and exclusion of those with hiatal hernias ≥ 2 cm, severe esophagitis, or functional esophageal disorders such as esophageal hypersensitivity.

The primary goal of this study is to improve patients' quality of life and reduce the reliance on chronic PPI therapy. Secondary objectives include assessing the safety profile of the Stretta procedure and its effectiveness compared to conservative management in a broader GERD population. By focusing on these outcomes, the study seeks to provide valuable insights into the role of Stretta as a therapeutic option in GERD management and its potential to fill a critical gap in current treatment modalities.

Eligibility criteria: Inclusion Criteria:

Verified symptomatic GERD despite PPI use, with persistent symptoms, desire to discontinue PPIs, or intolerance to them.

Pathological gastroesophageal reflux confirmed by positive 24-hour pH-metry with impedance.

Normal findings on high-resolution esophageal manometry (HRM) according to CCv4.0.

Age ≥ 18 years. Signed informed consent for participation in the trial and invasive procedures.

Exclusion Criteria:

Active severe reflux esophagitis (Los Angeles classification grade C or D). Barrett's esophagus. Esophageal peptic stricture or eosinophilic esophagitis. Hiatal hernia ≥ 2 cm. Malignancies. Abnormal findings on high-resolution esophageal manometry. Esophageal or subcardial varices. Pregnancy. Severe comorbidities or increased perioperative risk. Age \> 70 years due to increased perioperative risk and common comorbidities. Symptoms primarily attributable to functional dyspepsia, significant anxiety, or depression, with overlap to other disorders of gut-brain interaction (DGBI).

Primary outcomes:
measure: Proton pump inhibitors (PPI) use
timeFrame: 6 months
measure: Proton pump inhibitors (PPI) use
timeFrame: 12 months
measure: GERD Health Related Quality of Life questionaire
timeFrame: 6 months
measure: GERD Health Related Quality of Life questionaire
timeFrame: 12 months
measure: Reflux Severity Index score
timeFrame: 6 months
measure: Reflux Severity Index score
timeFrame: 12 months
Secondary outcomes:
measure: 24h pH-metry with impedance
timeFrame: 6 months
measure: 24h pH-metry with impedance
timeFrame: 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Military University Hospital Prague
Study officials:
References: