Fluorescent Cholangiography vs White Light for Bile Ducts Identification

Recently, a novel technique to visualize structures using fluorescent light and intravenous
dye has been developed.

Near Infrared Incisionless Fluorescent Cholangiography (NIFC) is a medical imaging technique
that uses fluorescence to detect properly labeled structures during surgery.

NIFC is performed using imaging devices with the purpose of providing real-time simultaneous
information from color reflectance images (white light) and fluorescence emission (near
infrared light). One or more light sources are used to excite and illuminate the sample.
Light is collected using optical filters that match the emission spectrum of the
fluorophore. Imaging lenses and digital cameras are used to produce the final image.

During laparoscopic cholecystectomies, the visualization of the extra-hepatic bile ducts
with fluorescence is called Near Infrared Incisionless Fluorescent Cholangiography (NIFC).
Fluorescence equipment and a dye are necessary in order to perform a NIFC, but the technique
requires no radiation or incision. A fluorescence dye is administrated intravenously at
least 45 minutes before the surgery, which is excreted by the liver and the bile duct The
Study is designed to compare the effectiveness of Near Infrared Fluorescence Cholangiography
(NIFC) to standard white light imaging (WLI) in visualizing and identifying the main biliary
and hepatic structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile
Duct, Cystic-CBD junction, Cystic-Gallbladder junction and any Accessory Ducts) during
laparoscopic cholecystectomy.

Eligible patients will be identified through clinical and test evaluation. Eligibility will
be verified by the patient's primary surgeon. The surgeon will determine the indication and
date of the surgery. Once a patient is confirmed as eligible, the surgeon will introduce the
study in detail. If after being introduced to the study and having had the opportunity to
ask questions, the patient is willing to participate, he/she will be asked to review and
sign the informed consent document .

Upon entry in the clinical trial patients will be randomly allocated to the intervention
arm. Data will be collected at enrolment time, during surgery, at the end of surgery and one
week after surgery.

Upon entry in the clinical trial, the master study database (REDCap, will randomly allocated
patients to one of the study arms (1:1) within site (1:1) using a computer generated random
sequence. This will provide an allocation sequence for each site. Once a patient is enrolled
and a database file in REDCap is initiated for that patient, he/she will be assigned
electronically to one of the study arms.

Patient will be blind to the intervention but surgeon blinding will not be feasible due to
the nature of the intervention. The study will involve a considerable number of surgeons in
each site, which should compensate any potential bias of some of them in favor or against
either approach.

Inclusion Criteria:

1. Patients of both genders

2. Minimum age: 18 years old

3. Spoken and written command of the language spoken in the country's center

4. Ability to understand and follow the study procedures and sign the informed consent

Exclusion Criteria:

1. Known allergies to iodides

2. Known history of coagulopathy

3. Known moderate or severe liver disease Women who are pregnant or breastfeeding, or
for whom possibility of pregnancy was not ruled out