Selective Indocyanine Green Injection of a Segmental Hepatic Artery Followed by Near-Infrared Fluorescence Guided Anatomical Liver Resection: A Feasibility Study

Phase 2

Recruiting

Conditions: liver cancer
Liver tumor
10019815
10019818

Registration Number: NL-OMON52161

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

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.

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: <30; in case of eGFR 30-59 metformin should be stopped >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, and/or probenecid; 11. Emergency surgery.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The feasibility of using intra-arterial ICG and embolization preoperatively to<br /><br>allow for liver segment visualization during anatomical liver resection.<br /><br>Visibility will be measured using a contrast ratio between normal liver<br /><br>parenchyma and ICG colored liver parenchyma. A signal-to-background ratio of<br /><br>1.6 provides sufficient contrast for an anatomical resection and will therefore<br /><br>be used as endpoint.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The optimal dosage for a sufficient signal-to-background ratio<br /><br>- The optimal timing of ICG administration for a sufficient<br /><br>signal-to-background ratio</p><br>