Hepatocellular carcinoma, hepatic adenoma, intrahepatic cholangiocarcinoma, colorectal liver metastases
Conditions
Interventions
Trade Name: Verdye
Product Name: Indocyanine green
Pharmaceutical Form: Powder for injection
Trade Name: Lipiodol
Pharmaceutical Form: Solution for injection
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Scheduled for open or laparoscopic anatomical liver resection; 2. Patients aged over 18 years old; 3. Has the ability to communicate well with the investigator in Dutch or English and willing to comply with the study design; 4. Signed informed consent prior to any study-mandated procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Previous major abdominal surgery 2. Known allergy or history of adverse reaction to ICG, lipiodol, gel foam, iodine or iodine contrast agents; 3. Child Pugh B or C 4. Portal hypertension or portal vein thrombosis 5. eGFR: 48 hours prior to Lipiodol administration and continued >48 hours after Lipiodol administration 6. Hyperthyroidism or a benign thyroid tumor; 7. Pregnant or breastfeeding women; 8. Scheduled for palliative surgery or terminally ill 9. Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives (following a detailed medical history and physical examination); 10. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid; 11. Emergency surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the feasibility of using intra-arterial ICG preoperatively to allow for liver segment visualization during anatomical liver resection.;Secondary Objective: 1. To investigate the dosage which provides sufficient contrast index of ICG in the liver segment compared to normal liver tissue. 2. To investigate the optimal timing of administration of the ICG-mixture without being washed out of a liver segment. ;Primary end point(s): The feasibility of using intra-arterial ICG and embolization preoperatively to allow for liver segment visualization during anatomical liver resection. Visibility will be measured using a contrast ratio between normal liver parenchyma and ICG colored liver parenchyma. A signal-to-background ratio of 1.6 provides sufficient contrast for an anatomical resection and will therefore be used as endpoint.;Timepoint(s) of evaluation of this end point: Evaluation of the SBR will take place after each patient. After each two patients either dose and/or time interval will be changed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time ideal window between intervention radiology and operation will be increased after every two successful liver segment visualizations (contrast ratio of =1.6). The endpoint for this parameter is 24 hours, and will be confirmed in 4 consecutive patients.;Timepoint(s) of evaluation of this end point: Evaluation of the SBR will take place after each patient. After each two patients either dose and/or time interval will be changed. | — |
Countries
Netherlands
Contacts
Public Contacto.d.bijlstra@lumc.nl
Leiden University Medical Center
Outcome results
None listed