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. 2020 Oct;9(5):615–639. doi: 10.21037/hbsn.2019.09.13

Table 3. Summary current clinical trials using ICG for cholecystectomy.

Clinical trial ID Title Institution Investigator n Design Dose Timing Fluorescence imaging system Comparator End points
NCT02070627 Near infrared fluorescence cholangiography (NIRF-C) during cholecystectomy—use in acute cholecystitis sub-study Ohio State Vimal et al. 6 Open label single arm 2.5 mg 30–60 min before surgery Stryker ICG vs. IOC Adverse events; anatomic ID rate; OR time
NCT02070640 Near infrared fluorescence cholangiography (NIRF-C) during cholecystectomy Ohio State Vimal et al. 99 Open label single arm 2.5 mg 30–60 min before surgery Stryker ICG vs. IOC Adverse events; anatomic ID rate; OR time
NCT02344654 Fluorescence cholangiography during cholecystectomy-a RCT Hvidovre niversity Hospital Lehrskov et al. 120 Randomized parallel, open label 0.05 mg/kg After intubation Not identified ICG vs. IOC ID rate of CD; time spent on fluorescence cholangiogram vs. IOC; surgeon satisfaction; adverse events; cost
NCT01424215 The use of fluorescent imaging for intraoperative cholangiogram during laparoscopic cholecystectomy Maimonides Medical Center Sherwinter et al. 100 Randomized parallel, open label Not identified Not identified Novadaq ICG vs. standard laparoscopic cholecystectomy OR time; adverse events; time to ID anatomic structures; autonomy to residents
NCT03812432 Cholecystocholangiography by direct intragallbladder injection of ICG Hospital Son Espases Romero et al. 80 Open label single arm Not identified On table VISERA ELITE II Not identified ID rate of anatomic structures
NCT02558556 FALCON: a multicenter randomized controlled trial Maastricht University Medical Center Van den Bos et al. 308 Randomized parallel, open label 2.5 mg After intubation Storz ICG vs. standard laparoscopic cholecystectomy Time to ID CVS; time to ID CD-CBD junction; ID rate of anatomic structures; OR time
NCT01410734 Fluorescence imaging on the da Vinci surgical system for intra-operative near infrared imaging of the biliary tree Multi-centered: Italy, Switzerland Intuitiv Surgical 72 Open label single arm 2.5 mg 30 min before surgery da Vinci Not identified ID rate of anatomic structures; outcomes
NCT02702843 Fluorescent cholangiography vs. white light for bile ducts identification Multi-centered: US, Argentina, Germany, Italy, Japan Rosenthal et al. 1,000 Randomized parallel, open label Not identified Not identified Not identified ICG vs. standard laparoscopic cholecystectomy ID rate of anatomic structures; outcomes
NCT01881399 Fluorescence versus intraoperative cholangiography in the visualization of biliary tree anatomy (FLARIOC) Service de Chirurgie Digestive et Endocrinienne-Nouvel Hôpital Civil Pessaux et al. 66 Open label single arm 5 mg Intraop da Vinci ICG vs. IOC ID rate of CD-CBD junction vs. IOC; accuracy of identification due to fluorescence; accuracy of identification due to augmented overlay; time to identification