2002 - STRETTA CLINICAL Endoluminal Delivery of Radiofrequency Energy to the Gastroesophageal Junction in Uncomplicated GERD: Efficacy and Potential Mechanism of Action
John K. DiBaise, MD, Randall E. Brand, MD, and Eamonn M. M. Quigley, MD
The American Journal Of Gastroenterology, 2002;97:833-842
OBJECTIVES: Single-center trial; sought to further examine efficacy and physiological effects of endoluminal delivery of radiofrequency energy to the gastroesophageal junction in patients with uncomplicated gastroesophageal reflux.
METHODS: Patients with chronic heartburn requiring maintenance antisecretory therapy but without a hiatal hernia >2 cm, severe esophagitis, or complications of gastroesopha-geal reflux disease were prospectively studied. Radiofrequency energy was delivered to the gastroesophageal junction using a transorally delivered, flexible bougie–tipped catheter and a thermocouple-controlled generator, under sedation and analgesia.
RESULTS: A total of 18 patients underwent successful out- patient treatment without a serious adverse event. A significant improvement in symptom scores (GERD Activity Index: 112.5 [range 76.2– 140.6] vs. 81.0 (74.2–97.6); p < 0.0001) and antacid use (17/wk [range 0 – 81] vs 0 (0 –10); p < 0.0001) was noted at 6-month follow-up. Although a decrease in all pH parameters were seen in the both the upper and lower esophagus, no statistical significance was reached.
CONCLUSIONS: Radiofrequency energy delivery to the region of the gastroesophageal junction provides effective symptom relief over the short term in patients with uncomplicated gastroesophageal reflux disease. It may achieve its therapeutic effect by reducing the frequency of transient lower esophageal sphincter relaxations triggered by gastric distension.