title: A lower dose of fluorescein sodium is more suitable for confocal laser endomicroscopy: a feasibility study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China; Department of Gastroenterology, Weihai Municipal Hospital, Weihai, Shandong, China.
authors.forename: Ya-Lin
authors.initials: YL
authors.lastname: Zhang
authors.affiliation: Department of Hepatobiliary Surgery, Weihai Municipal Hospital, Weihai, Shandong, China.
authors.forename: Liang
authors.initials: L
authors.lastname: Bai
authors.affiliation: Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Li
authors.affiliation: Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Ji
authors.affiliation: Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China.
authors.forename: Chang-Qing
authors.initials: CQ
authors.lastname: Li
authors.affiliation: Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China.
authors.forename: Xiu-Li
authors.initials: XL
authors.lastname: Zuo
authors.affiliation: Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China.
authors.forename: Ya-Fei
authors.initials: YF
authors.lastname: Yin
authors.affiliation: Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China.
authors.forename: Jia-Xin
authors.initials: JX
authors.lastname: Du
authors.affiliation: Department of Gastroenterology, Dezhou People's Hospital, Dezhou, Shandong, China.
authors.forename: Zhen-Zhen
authors.initials: ZZ
authors.lastname: Zhai
authors.affiliation: Department of Gastroenterology, Weihai Municipal Hospital, Weihai, Shandong, China.
authors.forename: Xiao-Zhong
authors.initials: XZ
authors.lastname: Gao
authors.affiliation: Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China.
authors.forename: Yan-Qing
authors.initials: YQ
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects; D016099:Endoscopy, Gastrointestinal; D005240:Feasibility Studies; D005260:Female; D019793:Fluorescein / Q000008:administration & dosage* / Q000009:adverse effects; D041981:Gastrointestinal Tract / Q000473:pathology*; D006801:Humans; D000069416:Intravital Microscopy / Q000379:methods* / Q000592:standards; D008297:Male; D008679:Metaplasia / Q000000981:diagnostic imaging; D018613:Microscopy, Confocal / Q000379:methods / Q000592:standards; D008875:Middle Aged; D010859:Pigmentation Disorders / Q000139:chemically induced; D059629:Signal-To-Noise Ratio; D016037:Single-Blind Method; D012880:Skin Pigmentation / Q000187:drug effects; D055815:Young Adult
chemical_list: D003287:Contrast Media; D019793:Fluorescein