Prospective randomized study of Maloney esophageal dilation--blinded versus fluoroscopic guidance

Controversy exists over the need for fluoroscopic guidance when performing Maloney esophageal dilation. This prospective randomized single-blinded study evaluated the safety and efficacy of blinded and fluoroscopic technique. A total of 162 dilations were performed in 43 patients with benign esophageal strictures referred for maintenance dilation, 88 randomized to blinded technique, and 74 to fluoroscopic guidance. Use of fluoroscopic guidance resulted in a higher rate of successful dilations than the blinded technique (96% vs. 80%, p less than 0.05) and greater operator accuracy in assessing success of dilation (98.6% vs. 85%, p less than 0.05). Although adverse events (such as passage into trachea, gross hematemesis, impaction in a hiatal hernia) occurred more often with blinded technique (11.3% vs. 5.4%), this difference did not reach statistical significance. However, recognition of adverse events was significantly greater with fluoroscopic guidance than with the blinded technique (100% vs. 20%, p less than 0.05). No difference existed between groups regarding speed of dilation, patient comfort, or blood on the dilator. Patients were unreliable in their assessment of dilation success. Fluoroscopic guidance is recommended when performing Maloney dilation.