FLoCaMB Study
Research type
Research Study
Full title
FLuorescence Cholangiography using Methylene Blue
IRAS ID
235484
Contact name
Thomas Barnes
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Laparoscopic removal of the gallbladder (cholecystectomy) is one of the most common operations undertaken worldwide. The gallbladder is filled up with bile which is made in the liver and transported to the gallbladder via tubes called bile ducts. The duct going into the gallbladder is divided as part of the operation. One of the risks of cholecystectomy is injury to the other important bile ducts during the operation. This can result in significant morbidity and even death to the patient and often requires additional procedures. The reason the bile ducts can be injured is that they are either in a different location than expected or a covered by a lot of surrounding tissue.
A way to try and visualise the ducts more clearly is to perform cholangiography (dye into the bile ducts). Traditionally this is performed under X-ray but this exposes patients & staff to radiation as well as being time consuming and unreliable. Fluorescence using near infra-red light is another way to perform cholangiography. Fluorescence involves shining near infrared (invisible) light onto a fluorophore (fluorescent molecule) which then becomes excited and returns near infrared light at a different wavelength.
Indocyaning Green (ICG) has so far been used in fluorescence cholangiography but must be given many hours in advance and can make the liver shine brightly confusing the image. Methylene blue is another potential method that will avoid these problems. It is also a widely used safe drug.
This is a proof of principle study using a prospective cohort of patients. It is unblinded and non-randomised. Patients will all be undergoing planned laparoscopic cholecystectomy and will all receive methylene blue at the start of their procedure. The fluorescence will be observed using a standard CE marked fluorescence marked camera.
REC name
Wales REC 5
REC reference
17/WA/0385
Date of REC Opinion
23 Nov 2017
REC opinion
Further Information Favourable Opinion