2007 - STRETTA CLINICAL Feasibility, safety, and efficacy of the Stretta procedure in Japanese patients with gastroesophageal reflux disease: first report from Asia
Kazuhide Higuchi, Yasuhiro Fujiwara, Hirotoshi Okazaki, Masahiko Tabuchi, Natsuhiko Kameda, Kaori Kadouchi, Hirohisa Machida, Tetsuya Tanigawa, Masatsugu Shiba, Toshio Watanabe, Kazunari Tominaga, Nobuhide Oshitani, and Tetsuo Arakawa
J Gastroenterol 2007; 42:205–210
BACKGROUND: In recent years, various endoscopic treatments have become available to treat gastroesophageal reflux disease (GERD) in Western countries. The Stretta procedure, which uses radiofrequency energy, is one type of safe and effective endoluminal treatment for GERD. However, the feasibility, safety, and efficacy of the Stretta procedure in Japanese patients with GERD, who differ from Western peoples in their physiological characteristics, are not known. In 2006, we imported a Stretta system from the United States and investigated important clinical aspects of the system in Japanese patients with GERD.
METHODS: This study was an open-label trial that enrolled patients with GERD who desired to undergo the Stretta procedure. Heartburn scores, medication use, overall satisfaction with the procedure, and adverse events were evaluated.
RESULTS: Nine patients received the Stretta treatment between February and September 2006. Esophagogastroduodenoscopy just after treatment revealed a remarkable reduction in the expansion of the gastric cardia and small erosions in all patients. At 3 or 6 months after treatment, heartburn scores were significantly improved compared with pretreatment scores (5.0 + 1.7 pretreatment vs. 0.7 + 1.4 posttreatment, P = 0.007). In six of nine patients (66.7%), treatment significantly (P = 0.009) decreased medication use. There were no major adverse events. All patients were satisfied with this treatment.
CONCLUSIONS: The Stretta procedure safely reduced GERD symptoms and decreased medication use in Japanese patients with GERD. This treatment may thus be very useful for such patients, and it is hoped that a nationwide trial will be undertaken in Japan to obtain more extensive data.