Testing the Use of Indocyanine Green Fluorescence Image-Guidance in Patients with Liver Surgery Compared To Patients with Standard Liver Surgery: A Feasibility Randomised Controlled Trial

Indocyanine-green Fluorescence-Image-Guidance (I-FIGS) is gaining popularity in liver surgery, yet its impact on reducing microscopic positive margins (R1-resection-rate) remains uncertain. The aim of this feasibility randomised-controlled-trial (fRCT) is to assess the logistics, recruitment, retention, and practicality of implementing I-FIGS in liver surgery to inform a full-scale multi-centre-RCT. Patients with liver tumours meeting the eligibility criteria were randomised to the control group (standard liver-surgery) or the I-FIGS group (standard liver-surgery + I-FIGS). Data were collected on demographics, screening, recruitment/retention rates, adherence to study methods, intraoperative details, and postoperative histology. Additionally, semi-structured-interviews were conducted with participants and analysed using thematic-analysis. From November 2022 -September 2023, 47 patients were screened, 42 recruited, and 29 analysed (control n = 15; I-FIGS n = 14). Overall adherence to study methods was 100%. The groups had comparable age and gender distribution. Compared to the control group, I-FIGS group had smaller median tumour size (34 vs. 20 mm), identical median blood loss (550 ml), shorter mean operating time (283.33 vs. 238.92 min), and reduced median hospital stay (7 vs. 4 days). Overall, 30-day-morbidity was lower in the I-FIGS group (40% vs. 7.4%). The R1 resection rate was comparable in both groups (25% vs. 28.6%). The fRCT demonstrated promising recruitment-rates and high adherence to study-methods. The results suggest potential benefits and improved patient-outcomes with I-FIGS. However, further research is required to study the role of I-FIGS in reducing R1 resection-rates. The qualitative findings provide valuable insights into participants’ experiences and can guide planning a multicentre-RCT.