FALCON: a Multicenter Randomized Controlled Trial
Cholecystolithiasis, Cholecystitis
About this trial
This is an interventional diagnostic trial for Cholecystolithiasis focused on measuring Laparoscopic cholecystectomy (LC), Indocyanine green (ICG), Near-Infrared Fluorescence Imaging (NIRF), Critical View of Safety (CVS)
Eligibility Criteria
Inclusion Criteria:
- Scheduled for elective laparoscopic cholecystectomy
- Normal liver and renal function
- No hypersensitivity for iodine or ICG
- Able to understand nature of the study procedures
- Willing to participate and with written informed consent
- Physical Status Classification: ASA I / ASA II
Exclusion Criteria:
- Age < 18 years
- Liver or renal insufficiency
- Known iodine or ICG hypersensitivity
- Pregnancy or breastfeeding
- Not able to understand nature of the study procedure
- Physical Status Classification: ASA III and above
- iv Heparin injection in the last 24 h; (LMWH not contraindicated)
Sites / Locations
- Maastricht University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
NIRF-LC
CLC
This group of patients will undergo near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy by use of a Laparoscopic Fluorescence Imaging System (Karl Storz), in combination with one intravenous injection of contrast agent ICG. The ICG is given directly after induction of anesthesia in a dose of 1 ml of 2,5 mg/ml solution. Intraoperatively every 2-5 minutes (more often if desired by surgeon) camera is switched to ICG mode for fluorescence cholangiography, until CVS is established. Registration of time until establishment of CVS, visualization of the individual structures as described as secondary endpoints, and total operation time will be done. The complete procedure will be recorded on video.
This group will undergo conventional laparoscopic cholecystectomy as in standard practice with no other intervention. Registration of time until establishment of CVS, visualization of the individual structures as described as secondary endpoints, and total operation time will be done. The complete procedure will be recorded on video. Postoperatively, as in the NIRF-LC arm, the videos will be analysed to determine whether CVS is actually established, is the transition of the cystic duct into the gallbladder visualized? Is transition of the cystic artery into the gallbladder visualized? Furthermore, cost-minimalisation will be calculated.