Clinical trial NCT05616039: I-FIGS Feasibility Study
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Liver Cancer
Hepatocellular Carcinoma
Liver Metastasis Colon Cancer
Keywords: Indocyanine green
Fluorescence Image Guided Surgery
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility Randomized Controlled Study
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Feasibility outcomes
timeFrame: 10 weeks (from the day of recruitment till the histopathology report is available)
measure: Clinical outcomes- Microscopic positive resection margin rate
timeFrame: From the day of surgery till the histopathology report is available (approximately 6 weeks)
Secondary outcomes:
measure: Number of additional tumours detected
timeFrame: On the day of surgery
measure: Duration of surgery
timeFrame: On the day of surgery
measure: Post-operative length of stay
timeFrame: From the day of surgery till the day of discharge (approximately 10 days)
measure: Complications
timeFrame: From the day of recruitment till the day of discharge (approximately 4 weeks)
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
Study officials:
affiliation: University Hospitals Plymouth NHS Trust
name: Somaiah Aroori
role: STUDY_DIRECTOR
affiliation: University Hospitals Plymouth NHS Trust
name: Rahi Karmarkar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mise Y, Sakamoto Y, Ishizawa T, Kaneko J, Aoki T, Hasegawa K, Sugawara Y, Kokudo N. A worldwide survey of the current daily practice in liver surgery. Liver Cancer. 2013 Jan;2(1):55-66. doi: 10.1159/000346225.
citation: Chan AWH, Zhong J, Berhane S, Toyoda H, Cucchetti A, Shi K, Tada T, Chong CCN, Xiang BD, Li LQ, Lai PBS, Mazzaferro V, Garcia-Finana M, Kudo M, Kumada T, Roayaie S, Johnson PJ. Development of pre and post-operative models to predict early recurrence of hepatocellular carcinoma after surgical resection. J Hepatol. 2018 Dec;69(6):1284-1293. doi: 10.1016/j.jhep.2018.08.027. Epub 2018 Sep 18.
citation: Joo I. The role of intraoperative ultrasonography in the diagnosis and management of focal hepatic lesions. Ultrasonography. 2015 Oct;34(4):246-57. doi: 10.14366/usg.15014. Epub 2015 Apr 6.
citation: Faybik P, Hetz H. Plasma disappearance rate of indocyanine green in liver dysfunction. Transplant Proc. 2006 Apr;38(3):801-2. doi: 10.1016/j.transproceed.2006.01.049.
citation: Ishizawa T, Saiura A, Kokudo N. Clinical application of indocyanine green-fluorescence imaging during hepatectomy. Hepatobiliary Surg Nutr. 2016 Aug;5(4):322-8. doi: 10.21037/hbsn.2015.10.01.