cholecystitis gall stones inflammation of the gall bladder
Conditions
Interventions
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
Sponsors
azM (academisch ziekenhuis Maastricht)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients scheduled for a laparoscopic cholecystectomy Able to understand the nature of the study and what will be required of them Males and females (not pregnant) Age >18 years Normal liver and renal function No hypersensitivity for iodine Willing to participate
Exclusion criteria
Exclusion criteria: Not able to give written informed consent Liver or renal insufficiency Iodine hypersensitivity Pregnant women Aged
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Identification of biliary anatomy - Identification of critical view of safety Assessment of NIRFC technique: - Video analysis - Intraoperative registration/evaluation form - Recognition of the biliary anatomy (at set time points: every 5-10 minutes) and moment of obtaining CVS - Speed and efficiency of the procedure - Safety of the procedure Time measurement: - time until CVS is obtained - time until fluorescence/conventional imaging is obtained of individual biliary structures - total operating time Later on, this can be compared to conventional laparoscopic cholecystectomy procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will register complications caused during the procedure: - Bile duct injury - Vascular injury We will register unsuspected adverse effects of the administered fluorescent dye | — |
Countries
Netherlands
Outcome results
None listed