Treatment of gastroesophageal reflux disease using radiofrequency ablation (Stretta procedure): An interim analysis of a randomized trial

Abstract

Background: Gastroesophageal reflux disease (GERD) is the most common chronic gastrointestinal disorder, affecting one third of the population worldwide. Recently, there has been a renewed interest in Stretta therapy in view of potential long-term side effects of PPIs and the durability of relief with fundoplication.

Method: Prospective randomized study comparing the Stretta treatment with controls receiving PPIs. Patient (> 18 years, n = 20) with symptoms of heartburn, regurgitation, abnormal esophageal acid exposure (≥ 4%), and endoscopically confirmed esophagitis were included into the study. The primary measure was improvement in quality of life (QOL) and decrease in the frequency and severity of GERD symptoms.

Results: The mean age of the patients was 39 (± 15) years and controls were 34 (± 11) years. Three months after Stretta, 80% reported improvement in QOL compared to 40% in the control group. At the end of 3 months, significant (p < 0.05) improvement in GERD symptom score for heartburn, regurgitation, chest pain, and cough compared with the control group was observed. After Stretta treatment, 60% of the patients were free of PPIs whereas there was no change in the control group. Almost 80% of the patients on Stretta treatment were satisfied with the treatment compared to 30% of the patients in the control group.

Conclusion: Stretta was effective in the short-term for the management of GERD.

Keywords: Clinical trial; Endotherapy; Esophagitis; Hiatus hernia; Symptom relief.