Low vs Standard-Dose Indocyanine Green in the Identification of Biliary Anatomy Using Near-Infrared Fluorescence Imaging: A Multicenter Randomized Controlled Trial

Abstract

BACKGROUND: Near-infrared fluorescence imaging using intravenous indocyanine green (ICG) facilitates intraoperative identification of biliary anatomy. We hypothesize that a much lower dose of ICG than the standard decreases hepatic and background fluorescence and improves bile duct visualization. STUDY DESIGN: In this multicenter randomized controlled trial, 55 adult patients undergoing laparoscopic cholecystectomy were randomized to low-dose (0.05 mg) or standard-dose (2.5 mg) ICG preoperatively on the day of surgery. A quantitative assessment was performed on recorded videos from the operation using ImageJ software to quantify the fluorescence intensity of the bile duct, liver, and surrounding/background fat. Operating surgeons blinded to ICG dose provided a qualitative assessment of various aspects of the visualization of the extrahepatic biliary tree comparing near-infrared fluorescence to standard visible light imaging using a scale of 1 to 5 (1, unsatisfactory; 5, excellent). Quantitative and qualitative scores were compared between the groups to determine any significant differences between the doses. RESULTS: The bile duct–to–liver and bile duct–to–background fat fluorescence intensity ratios were significantly higher for the low-dose group compared with the standard-dose group (3.6 vs 0.68, p < 0.0001; and 7.5 vs 3.3, p < 0.0001, respectively). Low-dose ICG had a slightly higher (ie better) mean score on the qualitative assessment compared to the standard dose, although the differences were not statistically significant. CONCLUSIONS: Low-dose ICG leads to quantitative improvement of biliary visualization using near-infrared fluorescence imaging by minimizing liver fluorescence; this further facilitates routine use during hepatobiliary operations.

Current Trends in Surgical Management of Hepatocellular Carcinoma

“…They found that the tumors that were not identified intraoperatively through the technique were significantly smaller (11 mm vs. 18 mm, p = 0.019) and located deeper in the liver (10 mm vs 2 mm, p < 0.001), not identifying any of the tumors that were deeper than 8 mm from the liver surface [87]. This method can also be used to identify the bile duct [88], a structure that, if injured, causes intra-and postoperative complications, such as bile leak and biliary stricture (Figure 3) [89]. A recent study has shown that decreasing the ICG dose to 0.05 mg, instead of the standard 2.5 mg, preoperatively decreases hepatic and background fluorescence, allowing for a clear bile duct visualization within 15-20 min from administration [88].…”

“…This method can also be used to identify the bile duct [88], a structure that, if injured, causes intra-and postoperative complications, such as bile leak and biliary stricture (Figure 3) [89]. A recent study has shown that decreasing the ICG dose to 0.05 mg, instead of the standard 2.5 mg, preoperatively decreases hepatic and background fluorescence, allowing for a clear bile duct visualization within 15-20 min from administration [88].…”

Indocyanine Green (ICG) Fluorescence-Assisted Open Surgery Using the Rubina® Lens System in the Pediatric Population: A Single-Center Prospective Case Series

“…The comparative analysis showed significantly lower The matched control group, without ICG-NIRF assistance, included nine boys with bilateral gynecomastia. The median patient's age at surgery was 14.6 years-old (range [12][13][14][15][16]. Five out of the nine patients (55.5%) developed postoperative seroma in the breast region, managed with needle aspiration in an outpatient setting (Clavien-Dindo 2).…”

“…The matched control group, without ICG-NIRF assistance, included five boys with a preauricular fistula. The median patient's age at surgery was 9.8 years-old (range [6][7][8][9][10][11][12][13][14]. Two out of the five patients (40%) developed postoperative complications, including surgical site infection and serous discharge from the surgical site, both managed with antibiotic therapy (Clavien-Dindo 2).…”

“…It undergoes no significant extrahepatic or enterohepatic circulation, and it is cleared exclusively through the liver. ICG is normally confined to the vascular stream, perfect for visualization of vascular perfusion, and entirely excreted into the biliary tract within a few hours from its injection, rendering it useful for visualizing biliary tract and flow [13,14]. The employment of fluorescence imaging has gained great popularity in many fields of adult surgery where it has demonstrated great potential in both open surgery and MIS [15,16].…”