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
Fluorescence imaging using indocyanine green (ICG) is undergoing extensive development. This study aimed to assess the merits of ICG in regard to hepatic surgery.
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).
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.
This study confirmed that intraoperative fluorescence is a helpful and relevant tool for the liver surgeon (NCT 01738217).
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