Does fluoroscopic guidance for Maloney esophageal dilation impact on the clinical endpoint of therapy: Relief of dysphagia and achievement of luminal patency

Background: Use of fluoroscopy for Maloney esophageal dilation is controversial. We designed this prospective, randomized, single-blinded study to determine whether fluoroscopic guidance has an impact on relief of dysphagia and achievement of luminal patency. Methods: Patients with benign esophageal strictures were randomized to undergo Maloney dilation with or without fluoroscopic guidance. Strictures were dilated to size 48F. Dysphagia scores were obtained before and 1 week after dilation. Results: Eighty-three patients underwent 100 dilation sessions with fluoroscopic guidance being used for 50 sessions (156 dilations) and blinded technique for 50 (161 dilations). A 12.5 mm barium pill passed after dilation following 62.0% of the fluoroscopic dilation sessions and 42.0% of the blinded dilations (p = 0.045). Dysphagia was improved in 93.0% of patients receiving fluoroscopic dilations and 69.0% of patients receiving blinded dilations (p = 0.006). The mean improvement in dysphagia score was -2.10 points for the fluoroscopic group versus -1.50 points for the blinded group (p = 0.057). Differences in these parameters between techniques were even greater in 12 patients re-randomized to both techniques at different sessions. Conclusions: The use of fluoroscopic guidance impacts favorably on the efficacy of Maloney dilation, resulting in greater relief of dysphagia and increased luminal patency compared to the blinded technique. Based on these results, use of fluoroscopy is recommended when Maloney esophageal dilation is performed.