Background and Aims
Image quality can be guaranteed with the conventional dosage of fluorescein sodium in probe-based confocal laser endomicroscopy (pCLE). However, yellow discoloration of the skin seriously affects daily life and simultaneously increases the risk of adverse events such as allergic reactions. The aim of this study was to test whether a lower dosage of fluorescein sodium can provide satisfactory image quality and to compare the diagnostic accuracy of gastric intestinal metaplasia (GIM) through a randomized blind controlled trial.
Consecutive patients were randomly assigned to different doses of fluorescein sodium. Image quality was determined by the endoscopists’ subjective assessments and signal-to-noise ratio (SNR) assessment systems. Skin discoloration was tested using a neonatal transcutaneous jaundice detector. In addition, consecutive patients with a known or suspected diagnosis of GIM were examined by pCLE with the lower dose and the traditional dose.
Only 0.01 mL/kg dose of 10% fluorescein sodium led to a significant decrease in image quality (P < .05), and a dose of 0.02 mL/kg had the highest SNR value (P < .05). There were no significant differences in skin discoloration between the 0.01 mL/kg and 0.02 mL/kg doses (P = .148) and no statistical difference in the diagnostic accuracy of pCLE for GIM between the 0.02 mL/kg and 0.10 mL/kg doses (P > .05). The kappa values for the correlation between pCLE and histopathology were 0.867 (95% confidence interval, 0.782–0.952) and 0.891 (95% confidence interval, 0.811–0.971).
The 0.02 mL/kg dose of 10% fluorescein sodium seems to be the best dose for pCLE in the upper GI tract, with comparable image quality with the conventional dose and insignificant skin discoloration. This dose is also very efficient for the diagnosis of GIM.
Abbreviations:CI (confidence interval), CLE (confocal laser endomicroscopy), GIM (gastric intestinal metaplasia), pCLE (probe-based confocal laser endomicroscopy), SNR (signal-to-noise ratio), TB (total bilirubin)
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Published online: May 14, 2016
Accepted: May 4, 2016
Received: December 9, 2015
DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
This study was funded by the National Natural Scientific Funding of China (NSFC81330012).
If you would like to chat with an author of this article, you may contact Dr Yan-Qing Li at [email protected]
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