HEPATOFLUO: A prospective monocentric study assessing
the benefits of indocyanine green (ICG) fluorescence for
hepatic surgery
Patrice Peyrat MD1,2; Ellen Blanc PhD3; Stéphanie Guillermet MSc4; Yao Chen MD2; Céline Ferlay MSc3; David Perol MD, PhD3;
Valéria Basso MD1; Michel Rivoire MD, PhD1,2; Aurélien Dupré MD, PhD1,2
 
1 Department of Surgery, Centre Léon Bérard,  Lyon, France; 
2 Experimental Surgical Unit, Centre Léon Bérard, Lyon, France 
3 Clinical Research and Innovation, Centre  Léon Bérard, Lyon, France; 
4 Fluoptics, Fluorescence Imaging for Surgery, Grenoble, France
BACKGROUND:
Fluorescence imaging using indocyanine green (ICG) is  undergoing extensive development. This study aimed to assess the merits of ICG in regard to hepatic surgery.
METHODS:
Patients with liver lesions that required a resection were eligible. They  received an injection of ICG the day before the surgery. Step 1 allowed assessment of use of the medical device under surgical conditions. Steps 2 and 3 assessed the capacity of theMDto detect known tumorous lesions and to spot a predefined area of the liver following injection of ICG into the portal vein (ICGp).
RESULTS:
The 1st step allowed for validation of the MD use with three patients.  Between 04-2013 and 04-2015, 45 pts were included (40 eligible) in steps 2 and 3. All of the tumorous lesions (95/119) exhibited fluorescence. Four new metastasis were detected in 3 pts, and two missing metastases in 1 pt. False positive were 22%. The maximal depth for detection by fluorescence was 13 mm. Injection of ICGp allowed the corresponding anatomical area to be identified in 16/20 patients.
CONCLUSION:
This study confirmed that intraoperative fluorescence is a helpful and  relevant tool for the liver surgeon (NCT 01738217).
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