Subject Category: Esophagus

Am J Gastroenterol 2012; 107:222–230; doi:10.1038/ajg.2011.395; published online 22 November 2011

A Double-Blind Sham-Controlled Study of the Effect of Radiofrequency Energy on Symptoms and Distensibility of the Gastro-Esophageal Junction in GERD

J Arts MD, PhD1, R Bisschops MD, PhD1, K Blondeau PhD1, R Farré PhD1, R Vos Ir1, L Holvoet MSc1, P Caenepeel MD, PhD1, A Lerut MD, PhD2 and Jan Tack MD, PhD1

  1. 1Department of Gastroenterology, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium
  2. 2Department of Thoracic Surgery, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium

Correspondence: Jan Tack, MD, PhD, Center for Gastroenterological Research, K.U. Leuven, 49 Herestraat, 3000 Leuven, Belgium. E-mail:

Received 26 September 2010; Accepted 13 September 2011; Published online 22 November 2011.





Several studies have reported symptom relief in gastro-esophageal reflux disease (GERD) patients treated with radiofrequency delivery (Stretta procedure) at the gastro-esophageal junction (GEJ), but the mechanism underlying this improvement is unclear. The objective of this study was to test the hypothesis that Stretta alters GEJ resistance.



We conducted a double-blind randomized cross-over study of Stretta and sham treatment. Consecutive GERD patients were included in the study. The study was conducted in a tertiary care center. Patients underwent two upper gastrointestinal endoscopies with 3 months interval, during which active or sham Stretta treatment was performed in a randomized double-blind manner. Symptom assessment, endoscopy, manometry, 24-h esophageal pH monitoring, and a distensibility test of the GEJ were done before the start of the study and after 3 months.



Barostat distensibility test of the GEJ before and after administration of sildenafil was the main outcome measure. In all, 22 GERD patients (17 females, mean age 47±12 years) participated in the study; 11 in each group. Initial sham treatment did not affect any of the parameters studied. Three months after initial Stretta procedure, no changes were observed in esophageal acid exposure and lower esophageal sphincter (LES) pressure. In contrast, symptom score was significantly improved and GEJ compliance was significantly decreased. Administration of sildenafil, an esophageal smooth muscle relaxant, normalized GEJ compliance again to pre-Stretta level, arguing against GEJ fibrosis as the underlying mechanism.



The limitation of this study was reflux evaluation did not include impedance monitoring. In this sham-controlled study, Stretta improved GERD symptoms and decreased GEJ compliance. Decreased GEJ compliance, which reflects altered LES neuromuscular function, may contribute to symptomatic benefit by decreasing refluxate volume.