Background and study aims: The purpose of this study was to investigate the safety and clinical effectiveness of a controlled radial expansion (CRE) balloon catheter in dilating benign esophageal strictures, and to assess factors influencing the effectiveness of this procedure.
Patients and methods: From February 2000 to June 2002, 25 patients with documented benign esophageal strictures at our hospital were enrolled and treated with CRE balloon dilation. There were 17 men and eight women, with ages ranging from 30 to 82 years. The average age of the enrolled patients was 56.1 years. All of the strictures were dilated using CRE dilators under direct visualization, without fluoroscopic monitoring. The dilation diameters were planned in series up to 15 mm using a "rule of three". If dysphagia and esophageal strictures recurred during the clinical follow-up after completion of a series of dilations, additional dilation was carried out until symptomatic relief was achieved. Effective treatment was defined as the ability of patients with or without repeated dilations to maintain a solid or semisolid diet for more than 12 months. Depending on the effectiveness and duration of treatment, the patients were divided into three groups: group A, the successful group in which the initial series of dilations was effective without the need for any additional dilation for recurrent strictures or dysphagia; group B, the relapse group, in which the initial series of dilations was effective, but additional dilations were needed due to recurrent strictures or dysphagia; and group C, the group in which the initial series of dilations failed or consecutive dilations could not be carried out due to intolerance.
Results: The 25 patients received a total of 95 sessions of dilation (3.8 +/- 1.2 sessions per patient). There were 11 patients in group A, 11 patients in group B, and three patients in group C. The median follow-up period was 16.5 months (range 12 - 32 months). The number of initial dilations required to achieve symptomatic relief showed a negative correlation with the pre-dilation diameter of the strictures ( r = - 0.92, P < 0.01). Thinner strictures required more dilations before symptomatic relief was achieved. In addition, the stricture length in group B (5.4 +/- 3.4 cm) was significantly longer than that in group A (2.6 +/- 1.1 cm) ( P = 0.009). The overall success rate was 88 % (22 of 25), including 100 % in the 21 patients with a stricture length of less than 8 cm and 25 % in the four patients with a stricture length more than 8 cm ( P = 0.02).
Conclusions: CRE balloon dilation without fluoroscopy is an effective treatment for esophageal strictures less than 8 cm in length. Pre-dilation diameter and stricture length are factors that influence the numbers of dilations required and the need for additional dilations.