I-FIGS Feasibility Study

Trial Title: I-FIGS Feasibility Study

NCT ID: NCT05616039

Condition: Liver Cancer
Hepatocellular Carcinoma
Liver Metastasis Colon Cancer

Conditions: Official terms:
Carcinoma, Hepatocellular
Liver Neoplasms

Conditions: Keywords:
Indocyanine green
Fluorescence Image Guided Surgery

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Feasibility Randomized Controlled Study

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Standard Liver Surgery
Description: Standard liver surgery using naked eye examination +/- palpation and intra-operative ultrasound scan (IOUS) examination to identify and remove liver tumours
Arm group label: Control Group (Standard liver surgery)
Arm group label: Intervention Group (I-FIGS)

Intervention type: Diagnostic Test
Intervention name: Indocyanine Fluorescent Image Guided Surgery (I-FIGS)
Description: Use of I-FIGS in accurate identification of tumours and their margins
Arm group label: Intervention Group (I-FIGS)

Summary: Background: Removal of part of the liver (resection) is performed as a treatment for some cancers in the liver. To achieve the best possible outcomes, it is important that the cancer is removed completely (R0 resection) (1). Up to 30-50% patients develop recurrence within 2 years of surgery which could be due to incomplete removal of the cancer (2). Various techniques are used by the surgeons to identify the cancer tissue from the normal liver during the surgery 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. Also, the interpretation of the ultrasound scan can be subjective (3). A robust, objective, real-time navigation technique is required which can differentiate cancer from normal tissue. Indocyanine green (ICG) is a dye which when given through the veins, is taken up and retained by cancer cells in the liver and they appear as fluorescent areas as compared to normal liver which appears dark. 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). It can also potentially detect additional tumours which were not identified before the surgery or during the surgery with standard techniques (4,5). 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 initial study aims to assess whether a larger trial evaluating the role of I-FIGS in complete removal of the cancer tissue is feasible. Investigators will assess if patients are willing to take part in the study and whether they can gather relevant clinical outcome data from them all. Investigators will also gather patients' views about this novel technique and participating in the study. Design and methods: This study will involve 40 patients having planned liver surgery for liver tumour/s recruited from University Hospitals, Plymouth. Patients will be randomly allocated to have I-FIGS plus standard surgery or standard liver surgery alone. Patients in the I-FIGS group will have ICG injection 2-4 hrs prior to surgery (0.03-0.05mg/kg dose) on the day of 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. Patient public involvement: Investigators have involved patients who have had or are having liver surgery in the development of the study. Their views on the technique, trial procedures and outcome measures have been incorporated. They will continue to be involved and advise on the study. Dissemination: Results will be available via research journals and conferences.

Criteria for eligibility:
Criteria:
Inclusion Criteria: • All adult patients (>16 years) requiring elective open/laparoscopic liver resection/s for liver metastases, primary hepatocellular and peripheral cholangiocarcinoma will be included in the study. Exclusion Criteria: - Patients allergic to iodine/contrast or shellfish - Patients unable to consent to the study - Patients with suspected liver adenomas and biliary cystadenomas - Patients with suspected hilar cholangiocarcinoma - Patients requiring emergency liver surgery - Pregnant patients

Gender: All

Minimum age: 16 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospitals Plymouth NHS Trust

Address:
City: Plymouth
Zip: PL6 8DH
Country: United Kingdom

Start date: November 23, 2022

Completion date: April 30, 2024

Lead sponsor:
Agency: University Hospital Plymouth NHS Trust
Agency class: Other

Source: University Hospital Plymouth NHS Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05616039