Real-time Intraoperative Near-Infrared Fluorescence Cholangiography Assisted Laparoscopic Cholecystectomy: A pilot study

Laparoscopic cholecystectomy is one of the most commonly performed endoscopic
procedures in gastrointestinal surgery. Bile duct injury (BDI) during this
surgery is rare but constitutes a serious complication (0.3-0.7%).
Misidentification of biliary anatomy during laparoscopic cholecystectomy
appears to be the largest cause of BDI. Intraoperative cholangiography (IOC) is
advised to reduce the risk of BDI. However, this imaging technique is only used
selectively. The process takes time, radiation exposure is involved and
additional equipment and manpower for the proceedings are required. Moreover,
worldwide consensus about the implementation of IOC is lacking.

Fluorescence cholangiography with preoperative indocyanin green (ICG)
administration is a promising new technique for easier intraoperative
visualization of the biliary anatomy and thereby it could improve the outcome -
safety and efficiency - of laparoscopic cholecystectomy.

Possible benefits of intraoperative fluorescence cholangiography compared to
conventional intraoperative cholangiography are the following:
1. The technique can save time.
2. Bile duct injury possibly caused by insertion of a trans-cystic catheter can
be avoided.
3. It is easier to apply, since only one preoperative injection of ICG is
needed. This allows the surgeon to obtain fluorescence images at any time,
without the aid of radiology staff.
4. The bile ducts may be better identifiable from the surrounding tissues.
5. It is a safe technique without radiation exposure; administration of ICG
also has a very small risk of an allergic reaction (0.003%) and has already
been approved for clinical use.

The main goal of this pilot study is to test feasibility of the present
commercially available near-infrared fluorescence cholangiography (NIRFC)
laparoscopic device during the laparoscopic cholecystectomy.

A prospective observational pilot study:
- The study will be conducted in the Maastricht University Medical Centre+
(MUMC+).
- The operations will be performed by two gastrointestinal surgeons, with
extensive experience in laparoscopic surgery.
- As usual, Critical View of Safety (CVS) technique will be used during the
operation.
- Visual recordings will be made during dissection to obtain CVS.

Storz® will provide the necessary apparatus (NIR fluorescence laparoscope,
modified light source and light cable) and technological support.

ICG will be delivered by the logistics department of the hospital pharmacy of
MUMC+.

After surgery the NIRFC technique will be assessed by an intraoperative
registration/evaluation form.
Visual recordings will be analyzed.

TNO, Department of Imaging, will also provide technological support for image
processing.

Study subjects receive 2 intravenous injections of 1ml ICG (2.5mg/ml).

Comment:
- 1 x 1ml ICG injection preoperative (directly after induction of anesthesia),
in order to visualize the extra-hepatic bile ducts during the laparoscopic
procedure using the fluorescence technique.
- 1 x 1ml ICG injection intraoperative (at the moment of determination of CVS /
critical view of safety), in order to visualize the arterial phase using the
fluorescence technique (<10 seconds after this injection).

Compared with standard care, patients have to receive one preoperative and one
intraoperative intravenous injection of a contrast agent, indocyanin green
(ICG). This is the only additional invasive action for the patient.
Initially, patients participating in this study will not benefit from the
application of NIRFC during the surgical procedure.
The administration of ICG (FDA approved and already used for several clinical
diagnostic indications) and the modified laparoscope itself are not related
with any kind of additional risk for the patient.

Only a small sample size is needed, as it is expected that the outcome of this
study will be of great importance for the further application of the NIRFC
technique in laparoscopic cholecystectomy.