I-FIGS feasibility study 1.0
Research type
Research Study
Full title
A feasibility randomised controlled study to test the use of Indocyanine green Fluorescence Image-Guidance in liver Surgery compared to standard liver surgery alone in reducing microscopic positive tumour resection rate (I-FIGS)
IRAS ID
317378
Contact name
Somaiah Aroori
Contact email
Sponsor organisation
University Hospital Plymouth NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Background
Removal of part of the liver (resection) is performed as a treatment for some liver cancers. To achieve the best possible outcomes, it is important that the cancer is removed completely (R0 resection). Up to 30-50% patients develop recurrence within 2 years of surgery which could be due to incomplete removal of the cancer. Various techniques are used by the surgeons to identify the cancer tissue so that it can be removed completely. These include examining with the naked eye, having a feel of the tumour, and performing an ultrasound scan. Even with these techniques it is difficult to identify the exact extent of the cancer. A robust, objective, real-time navigation technique is required which can differentiate cancer from normal tissue.
Indocyanine green (ICG) is a dye which is taken up and retained by cancer cells and they appear as fluorescent areas as compared to normal liver. This principle can be used to identify the cancerous tissue accurately during the surgery and remove it completely (Indocyanine green Fluorescence Image-Guided Surgery: I-FIGS). However, there is a lack of good quality evidence on the usefulness of I-FIGS in liver surgery, so this needs to be tested in a large group of patients having liver surgery before any recommendations can be made.
Research Aim
This study aims to assess whether a larger trial evaluating the role of I-FIGS in complete removal of the cancer tissue is feasible. We will assess if people are happy to take part in the study and whether we can gather relevant outcome information from them all. We will also gather their views about this novel technique and participating in the study.
Design and methods
This study will involve 40 people undergoing liver surgery for liver tumour at University Hospitals Plymouth. Patients will be randomly allocated to have I-FIGS plus standard surgery or standard surgery alone. Patients in the I-FIGS group will have ICG injection 2-4 hrs prior to surgery. The surgical planning will be carried out as per the standard approach using the naked eye and intra-operative ultrasound examination. Once this is all recorded, ICG cameras will be switched on, and the additional findings and change to surgical plan will be noted. Focus groups will explore participants experiences of being in the study. This will inform the design of the future larger trial.Summary of results
: Our study successfully achieved all its goals, confirming that our research approach is feasible and effective. Over a period of 10 months (from November 2022 to September 2023), we screened 47 patients, recruited 42 of them (89%), and analyzed data from 29 patients (15 in the control group and 14 in the I-FIGS group). We strictly followed our planned methods, with 100% adherence to procedures like consent, randomization, and data collection. This high level of adherence and the strong recruitment rates suggest that we can successfully conduct a larger study in the future.Both the control and I-FIGS groups were similar in terms of age and gender, ensuring a fair comparison. The I-FIGS technique showed promising results: patients in this group had smaller tumors, shorter surgeries (about 239 minutes vs. 283 minutes in the control group), and shorter hospital stays (4 days vs. 7 days in the control group). Importantly, fewer patients in the I-FIGS group experienced complications within 30 days after surgery (7% vs. 40% in the control group).
The rate of successful tumor removal was similar in both groups, with a slightly lower resection margin positivity in the I-FIGS group (25% vs. 28.57% in the control group). The I-FIGS technique also detected one additional tumor but missed four, with a 15.38% false positive rate. These findings suggest that the I-FIGS technique could potentially improve surgical outcomes, making it a promising approach for future research and clinical use.
Our study also revealed potential challenges, such as the need for timely administration and addressing logistical issues like bed availability. Both patients and surgeons supported the idea of expanding the study to include more hospitals, emphasizing the importance of careful planning to maintain consistency.
Overall, participants were happy with the study, appreciated the clear communication, and felt their involvement was valuable. Their positive feedback and suggestions for improvement will help us refine our approach for a larger trial.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
22/WM/0198
Date of REC Opinion
25 Oct 2022
REC opinion
Further Information Favourable Opinion