A feasibility randomized controlled trial testing the use of indocyanine green fluorescence image-guidance in liver surgery compared to standard liver surgery alone in reducing microscopic positive tumor margin resection rate with an embedded qualitative study: the I-FIGS study protocol

Abstract

Abstract Indocyanine green fluorescence image-guidance (I-FIGS) is gaining global popularity in liver surgery for various applications. However, its true clinical value in reducing microscopic positive margins (R1-resection rate) remains uncertain. To address this, a multi-center randomized controlled trial (RCT) comparing I-FIGS with standard liver surgery is needed. However, due to a lack of essential information on potential R1 reduction rate, sample size, methodology, intervention delivery and patient experience, a feasibility RCT protocol has been developed to determine the viability of conducting a full-scale RCT. The aim of the study is to conduct a feasibility RCT (fRCT) with an embedded qualitative study to gather all the necessary information for a full-scale RCT. Adult patients undergoing elective liver surgery for colorectal liver metastasis (CRLMs), hepatocellular carcinoma (HCC) or peripheral cholangiocarcinoma will be eligible for the study. Forty patients will be randomly assigned to either the control group (standard liver surgery) or the intervention group (standard liver surgery + I-FIGS). Patients in the I-FIGS group will receive intravenous injection of 0.03–0.05 mg/kg indocyanine green (ICG) dye 2–4 hours before the surgery. Data will be collected on demographics, screening, recruitment and retention rates, adherence to study methods, intraoperative details, postoperative histology, and experiences of both surgeons and patients. Interviews will be conducted with selected patients and surgeons to explore their experiences with the intervention. The protocol has been approved by the West-Midlands-Solihull Research Ethics Committee and registered with ClinicalTrials.gov (NCT05616039). The results will be disseminated through academic publications, congresses, newsletters and other platforms.