The safety of intravenous fluorescein for confocal laser endomicroscopy in the gastrointestinal tract.
BACKGROUND
Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging. Fluorescent contrast agents are used to optimize imaging with CLE, and intravenous fluorescein is the most widely used contrast agent. Fluorescein is FDA-cleared for diagnostic angiography of the retina. For these indications, the safety profile of fluorescein has been well-documented; however, to date, fluorescein is not cleared for use with CLE.


OBJECTIVE
To estimate the rate of serious and total adverse events attributable to intravenous fluorescein when used for gastrointestinal CLE.


METHODS
We performed a cross sectional survey of 16 International Academic Medical Centres with active research protocols in CLE that involved intravenous fluorescein. Centres using i.v. fluorescein for CLE who were actively monitored for adverse events were included.


RESULTS
Sixteen centres performed 2272 gastrointestinal CLE procedures. The most common dose of contrast agent was 2.5-5 mL of 10% sodium fluorescein. No serious adverse events were reported. Mild adverse events occurred in 1.4% of individuals, including nausea/vomiting, transient hypotension without shock, injection site erythema, diffuse rash and mild epigastric pain. The limitation is that only immediate post procedure events were actively monitored.


CONCLUSIONS
Use of intravenous fluorescein for gastrointestinal CLE appears to be safe with few acute complications.
Wallace
M B
MB
Department of Medicine, Mayo Clinic, Jacksonville, FL, USA. Wallace.michael@mayo.edu
Meining
A
A
Canto
M I
MI
Fockens
P
P
Miehlke
S
S
Roesch
T
T
Lightdale
C J
CJ
Pohl
H
H
Carr-Locke
D
D
Löhr
M
M
Coron
E
E
Filoche
B
B
Giovannini
M
M
Moreau
J
J
Schmidt
C
C
Kiesslich
R
R
D003287:Contrast Media / Q000009:adverse effects*; D003430:Cross-Sectional Studies; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D005076:Exanthema / Q000139:chemically induced / Q000453:epidemiology; D019793:Fluorescein / Q000009:adverse effects*; D005767:Gastrointestinal Diseases / Q000175:diagnosis*; D006801:Humans; D007022:Hypotension / Q000139:chemically induced / Q000453:epidemiology; D007275:Injections, Intravenous / Q000009:adverse effects; D018613:Microscopy, Confocal / Q000379:methods; D009325:Nausea / Q000139:chemically induced / Q000453:epidemiology; D010146:Pain / Q000139:chemically induced / Q000453:epidemiology; D014481:United States; D014486:United States Food and Drug Administration; D014839:Vomiting / Q000139:chemically induced / Q000453:epidemiology
D003287:Contrast Media; D019793:Fluorescein