intraoperative clarification of bile duct anatomy using NIR fluorescence imaging
Conditions
Interventions
Patients will be divided in several groups and receive either 5 or 10 mg ICG, administered (iv)30 min, 2h, 4h, 6h or 24 hours prior to surgery. Standard laparoscopic cholecystectomy will be performed.
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: Patients (>18 years old) suffering from benign gallbladder pathology, planned to undergo laparoscopic cholecystectomy
Exclusion criteria
Exclusion criteria: 1. Allergy for jodide or indocyanine green; 2. Hyperthyroidism or autonomous thyroidal adenoma; 3. Pregnancy; 4. Severe renal impairment (eGFR<55)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Identification of bile ducts using laparoscopic NIR fluorescence imaging during laparoscopic cholecystectomy. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Distinctive character of fluorescence imaging of bile ducts vs. liver after injection of either 5 or 10 mg ICG after several time points -Evaluation of applicability of NIR fluorescence imaging during laparoscopic cholecystectomy by performing questionnaire after surgery | — |
Contacts
Public ContactC.J.H. Velde, van de
Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600
Outcome results
None listed