High- and low-compliance balloon dilators in patients with achalasia: A randomized prospective comparative trial

Background: Pneumatic dilation is the most effective nonsurgical method for treatment of achalasia. The most serious complication of this procedure is esophageal perforation, which occurs in about 5% of cases. We completed a randomized prospective comparative trial with a high-compliance latex balloon (HCB) mounted on an endoscope (40 mm maximum distension diameter, 6 psi inflation pressure) and a low-compliance balloon (LCB) (35 mm, 20 psi) with respect to efficacy and side effects. Methods: Twenty-five patients (13 treated with HCB, 12 treated with LCB) were included. The symptom score was assessed both before and after dilation, biannually, for up to 2 years, and complications were graded for severity, All dilations lasted for 3 minutes and were performed under direct endoscopic control. Patients were randomly assigned to the two different balloon types. Results: One perforation was observed in the LCB group (not significant between HCB and LCB). Superficial mucosal tears appeared in 40% of all dilations. Initial dilation treatment was successful in 20 of 25 (80%) patients (10 of 13 HCB, 10 of 12 LCB). There were no significant differences in the median pretreatment and post-treatment symptom scores, Three patients required repeated dilations during the observation period. They were treated with the competing balloon system and showed no difference compared with the initial posttreatment symptom score. Conclusions: No significant difference could be demonstrated between the HCB and LCB system as far as the complication rate and the clinical outcome are concerned. In consequence, both systems appear equally effective, although the endoscope-mounted system (HCB) can be handled more easily.