Cholecystitis, Gallstones
Conditions
Keywords
Fluorescence, Cholangiography, Indocyanine Green, Cholecystectomy, Laparoscopic
Brief summary
The primary objective is to compare the success rates of intraoperative fluorescent cholangiography using indocyanine green versus conventional X-ray cholangiography for the identification of bile duct anatomy during laparoscopic cholecystectomy for complicated gallstone disease in a randomized design with 120 patients.
Interventions
DRUGIndocyanine green
DEVICENear-infrared illumination
To see the fluorescence from indocyanine green
DRUGUrografin
RADIATIONX-ray
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for planned laparoscopic cholecystectomy by one surgeon * Complicated gallstone disease
Exclusion criteria
* Open cholecystectomy * Allergy towards iodine, urografin or indocyanine green * Liver or renal insufficiency * Thyrotoxicosis * Pregnancy or lactation * Legally incompetent for any reason * Withdrawal of inclusion consent at any time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visualization of the cystic duct - common hepatic duct - common bile duct junction | Intraoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography | Intraoperative | — |
| Surgeon satisfaction score (Measured on a 5 point VAS scale) | Intraoperative | Measured on a 5 point VAS scale |
| Per-/postoperative adverse events as a measure of safety and tolerability | Intraoperative | — |
| Total cost of operation incl fluorescent/conventional X-ray cholangiography | Admission to discharge from hospital (0-30 days) | — |
Outcome results
None listed