OBJECTIVES: The endoluminal delivery of radiofrequency energy to the gastroesophageal junction has been shown to decrease symptoms of gastroesophageal reflux disease in a multicenter study. In this single-center trial, we sought to further examine its efficacy and physiological effects in patients with uncomplicated gastroesophageal reflux disease. METHODS:Patients with chronic heartburn requiring maintenance antisecretory therapy but without a hiatal hernia >2 cm, severe esophagitis, or complications of gastroesophageal 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. The primary outcome measure was effect on reflux symptoms, assessed at baseline and at 1, 3, and 6 months, after treatment. Other outcome measures included effects on antireflux medication use, quality of life, overall patient satisfaction, esophageal motility, esophageal acid exposure, esophageal wall thickness, appearance of the cardioesophageal flap valve, and vagal efferent function. RESULTS: A total of 18 patients underwent successful outpatient treatment without a serious adverse event. A significant improvement in symptom scores (Gastroesophageal Reflux Disease [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. No adverse effect on abdominal vagal function was identified and no significant change in any esophageal motility parameter was seen; however, a trend was noted toward a reduction in the number of transient lower esophageal sphincter relaxations induced by gastric air distension (3.5/h vs 1.0/h, p = 0.13). No detrimental effects on peristalsis or swallow-induced lower esophageal sphincter relaxation pressure were seen. Nonsignificant trends (p = 0.06) were noted regarding a decrease in the Hill score and an increase in esophageal wall thickness after treatment. Finally, although a decrease in all pH parameters in both the upper and lower esophagus was seen, none reached statistical significance. 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.
RCT Entities:
OBJECTIVES: The endoluminal delivery of radiofrequency energy to the gastroesophageal junction has been shown to decrease symptoms of gastroesophageal reflux disease in a multicenter study. In this single-center trial, we sought to further examine its efficacy and physiological effects in patients with uncomplicated gastroesophageal reflux disease. METHODS:Patients with chronic heartburn requiring maintenance antisecretory therapy but without a hiatal hernia >2 cm, severe esophagitis, or complications of gastroesophageal 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. The primary outcome measure was effect on reflux symptoms, assessed at baseline and at 1, 3, and 6 months, after treatment. Other outcome measures included effects on antireflux medication use, quality of life, overall patient satisfaction, esophageal motility, esophageal acid exposure, esophageal wall thickness, appearance of the cardioesophageal flap valve, and vagal efferent function. RESULTS: A total of 18 patients underwent successful outpatient treatment without a serious adverse event. A significant improvement in symptom scores (Gastroesophageal Reflux Disease [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. No adverse effect on abdominal vagal function was identified and no significant change in any esophageal motility parameter was seen; however, a trend was noted toward a reduction in the number of transient lower esophageal sphincter relaxations induced by gastric air distension (3.5/h vs 1.0/h, p = 0.13). No detrimental effects on peristalsis or swallow-induced lower esophageal sphincter relaxation pressure were seen. Nonsignificant trends (p = 0.06) were noted regarding a decrease in the Hill score and an increase in esophageal wall thickness after treatment. Finally, although a decrease in all pH parameters in both the upper and lower esophagus was seen, none reached statistical significance. 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.
Authors: L Cipolletta; G Rotondano; L Dughera; A Repici; M A Bianco; C De Angelis; A M Vingiani; E Battaglia Journal: Surg Endosc Date: 2005-05-03 Impact factor: 4.584
Authors: William O Richards; Hugh L Houston; Alfonso Torquati; Leena Khaitan; Michael D Holzman; Kenneth W Sharp Journal: Ann Surg Date: 2003-05 Impact factor: 12.969