Ureter Identification with IRDye 800BK
Research type
Research Study
Full title
Safety and efficacy of an investigational imaging agent in ureter identification via fluorescence detection during laparoscopic abdominal surgery.
IRAS ID
222066
Contact name
Chris Cunningham
Contact email
Sponsor organisation
Joint Research Office
Eudract number
2017-003283-12
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This trial will examine how safe the use of a new fluorescent dye is in showing the position of the ureter tubes and how well it works. This will help surgeons avoid injuring these tubes when performing surgery
The ureters are tubes which transport urine from the kidneys to the bladder. During particular types of abdominal surgery, there is a risk of injuring the ureter which could lead to problems and affect the quality of life for patients.
During bowel surgery, it is essential for the surgeon to be aware of where the ureter is to avoid injury and to allow the surgery to be as accurate as possible.
During kidney donor operations (donor nephrectomy) it is essential to know where the ureter is in order to maintain its blood supply and preserve it for transplantation. It is important for the surgeon to be precise and not to damage the blood supply so that when the kidney is transplanted in a recipient patient there is no risk of any narrowing in the ureter which can cause a blockage of urine flow.
Near infra-red (NIR) fluorescent dyes emit light in the invisible light spectrum when they are 'excited' by light at a certain wavelength. Previously, we have used methylene blue dye to identify the ureter during surgery. Whilst this gave us good results, there are now higher spectrum NIR dyes which show the tissue in greater depth. The one we would use is IRDye 800BK. It is a new near infra-red dye which has already been used in humans in the US. It was used to help surgeons working with 9 patients in a US based clinical trial without any adverse effects. Pre-clinical animal studies demonstrated no side effect at doses over 230 times the maximum dose intended in this trial.
Those patients that take part in the study will be told that the IRDye 800BK will be used. The study will look at how efficient and safe this dye is. It will also check the correct amount to ensure the best results and the correct timing to show this.
Two groups will receive the dye and one group of patients will have data only collected:
Group A will be participants undergoing colorectal surgery.
Group B will be participants undergoing laparoscopic donor nephrectomy.
Transplant Recipients: For safety purposes only, we will be collecting data from patients who have received the donated kidney from group B participants (transplant recipients).REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0021
Date of REC Opinion
9 Feb 2018
REC opinion
Further Information Favourable Opinion