A randomized prospective study comparing rigid to balloon dilators for benign esophageal strictures and rings,☆☆

https://doi.org/10.1016/S0016-5107(99)70337-8Get rights and content

Abstract

Background: The optimum choice of dilator (rigid vs. balloon) for benign esophageal strictures has not been well studied. The aim of this study was to compare the immediate relief of dysphagia and the incidence of repeat dilatation within the first year with the use of either a rigid (Savary) dilator or balloon dilator for benign lower esophageal strictures. Methods: Patients with dysphagia found to have benign esophageal strictures during endoscopy were randomized to undergo dilation with a rigid (Savary) or a balloon dilator (Microvasive or Bard). The 1-year incidence of repeat dilatation was estimated by the Kaplan-Meier method. Results: A total of 251 subjects were stratified at entry according to the type of stricture (peptic vs. Schatzki ring) and severity of stricture (mild vs. moderate/severe) and then randomized to either a Savary (n = 88), Microvasive (n = 81), or Bard (n = 82) dilator. There were no significant differences between the rigid dilator or the two balloons with regard to immediate relief of dysphagia or the need for repeat dilatation at one year. Patients with moderate/severe strictures required repeat dilatation at one year twice as often as those with mild strictures. There were no significant complications reported in these patients. Conclusions: Both rigid and balloon dilators are equally effective and safe in the treatment of benign lower esophageal strictures caused by acid reflux and Schatzki rings. (Gastrointest Endosc 1999;50:13-7.)

Section snippets

PATIENTS AND METHODS

Patients seen at our institution from January 1995 through January 1996 with complaints of dysphagia were eligible for participation in the study, which was approved by the institutional review board of our institution. At the initial visit the patient's ability to swallow was graded according to a five-point dysphagia scale (Table 1).All patients then had an upper endoscopy. Patients whose stricture appeared benign and who had provided informed consent were then randomized for the study. The

RESULTS

Two hundred fifty-one subjects were randomized to either Bard (n = 82), Microvasive (n = 81), or Savary (n = 88) dilators. Nine subjects were not compliant with any of the follow-up questionnaires (two Bard-treated patients, six Microvasive-treated patients, and one Savary-treated patient). The randomized groups were equally balanced with respect to age, gender, type, and severity of stricture (Table 2).

. Patient entry characteristics

Empty CellBalloonEmpty Cell
Empty CellBardMicrovasiveSavary
n828188
Age (yr, mean ± SD)64 ± 1163

DISCUSSION

Previous studies comparing rigid to balloon dilators for dilation of benign distal esophageal strictures have included small numbers of patients, and results have been variable.5, 6, 7, 8, 9 A recent study suggested that rigid and balloon dilators are equally effective.5 It has been shown that the majority of patients with benign strictures experience immediate relief of their dysphagia, but approximately 50% require further dilatation within one year.10, 11 Our study confirms that the majority

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Reprint requests: Keith D. Lindor, MD, 200 First St. SW, Rochester, MN 55905.

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