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

Asian Institute of Gastroenterology, India

Status and phase: Unknown; Phase 3

Conditions: GERD

Treatments: Device: Radio Frequency Ablation (RFA) (Stretta Procedure); Procedure: Sham Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02935881

aigstretta 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

RFA (Stretta Procedure)

Active Comparator group

Description:

Radio Frequency Ablation (RFA) using a Stretta device.

Treatment:

Device: Radio Frequency Ablation (RFA) (Stretta Procedure)

Placebo Arm

Sham Comparator group

Description:

Stretta device used but RFA will not be generated.

Treatment:

Procedure: Sham Procedure