Abstract
BACKGROUND: The current treatment of benign esophageal strictures often relies on the use of successively larger reusable Savary dilators or disposable balloon catheters. Recently, a new balloon catheter has been designed in which the balloon material has been preprogrammed to reach three successively larger sizes, depending upon the inflation pressure. This allows one balloon to provide dilatation to three different diameters (CRETM balloon, Microvasive). AIM: To provide a prospective, multi-center, randomized comparison of the CRETM balloon to a standard balloon dilator with regards to ease of use, complications, and effectiveness in patients with benign esophageal strictures. METHODS: A total of 60 patients were studied. Forty men and 20 women, mean age of 67 (range 24-87), with benign esophageal strictures were randomized based on stricture severity. At the time of entry, the two groups were comparable with regards to age, gender, history of previous dilatation, presence of esophagitis, use of antireflux medication, severity of dysphagia, and stricture severity. The mean lumen diameter prior to dilatation was 12.3 mm in the CRETM group and the standard group was 12.7 mm. RESULTS: In comparing the effectiveness of the two groups, the dysphagia score within the first day was reduced by 3.5 in the CRETM group vs. 2.6 in the standard group, p=0.07. Maximum dilatation obtained was 17.3 mm in the CRETM group versus 17.1 mm in the standard group. Dilatation time was comparable, although the CRETM balloon deflated more quickly than the standard, 6 versus 28 seconds. A slightly smaller number of CRETM balloons were used per case than standard dilators, 1.2 versus 1.4. There was a trend in favor of the CRETM balloon in regards to effectiveness at one month with an improvement in dysphagia score of 2.8 vs. 1.9 (p=0.07). CONCLUSIONS: The CRETM balloon works at least as well as the standard balloon in dilatation of benign esophageal strictures. The CRETM balloon allows dilatation to progressively larger diameters using a single catheter. There is a trend that suggests the CRETM balloon might allow more effective dilatation with an increase in lumen size and reduction of symptoms. These trends should be explored in the context of a larger-scale randomized trial.
