ADMINISTRATION OF MUCOLYTIC SOLUTION BEFORE UPPER ENDOSCOPY – A DOUBLE-BLIND, RANDOMISED STUDY

Aims:

Upper endoscopy is a basic examination of the esophagus, stomach and duodenum. Visibility of the mucosa is pivotal for successful diagnosis, especially of early neoplastic lesions. The data on possible effect of the mucolytics administered before the examination are limited. Our trial was designed to evaluate effect of mucolytic solution on mucosal visibility during upper endoscopy.

Methods:

In a randomised, single-center study, 134 patients indicated for diagnostic upper endoscopy were randomised either to administration of mucolytic solution 30 minutes prior to endoscopy (100 ml water + 400 mg N-acetylcysteine + 20 mg simethicone) (A), to standard endoscopy (B), or to administration of 100 ml of clear water prior to endoscopy (C). The primary endpoint was “visibility score” (0 – 25) defined as a sum of 5 scores (0 – 5) assessed by blinded endoscopist in the esophagus, fornix, corpus, antrum and duodenum. During the examination, 11 photos were taken in defined areas, which were later evaluated by other two blinded endoscopists using the same scale. The second endpoints were total examination time and amount of residual fluid in the stomach (0 – 3).

Results:

The basic characteristics of the population (sex, age) were comparable among the arms. The visibility score was not different among the arms (mean ± SD): 17.4 ± 1.9 (A) vs. 17.0 ± 2.0 (B) vs. 17.6 ± 1.8 (C) (p = 0.32). Examination time was also comparable (7.8 ± 1.5 vs. 7.9 ± 1.6 vs. 7.6 ± 1.7 min, p = 0.31), as well as the amount of residual fluid in the stomach (2.5 ± 0.7 vs. 2.4 ± 0.7 vs. 2.2 ± 0.6, p = 0.12).

Conclusions:

Administration of the mucolytic solution before upper endoscopy did not significantly improve the visibility of the mucosa and did not affect the duration of the examination and the amount of residual fluid in the stomach.