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

Conditions: Hepatocellular carcinoma, intrahepatic cholangiocarcinoma, liver metastases

Registration Number: NL-OMON21492

Lead Sponsor: MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following 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

A potential subject who meets any of the following criteria will be excluded from participation in this study:
1.Previous major abdominal surgery
2.Known allergy or history of adverse reaction to ICG, lipiodol, gel foam, iodine or iodine contrast agents;
3.Severe liver insufficiency;
4.eGFR: <30;
5.Hyperthyroidism or a benign thyroid tumor;
6.Pregnant or breastfeeding women;
7.Scheduled for palliative surgery or terminally ill
8.Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination);
9.Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid and/or metformin;
10.Emergency surgery.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the feasibility of using intra-arterial ICG and embolization preoperatively to allow for liver segment visualization during anatomical liver resection.

Secondary Outcome Measures

Name	Time	Method
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.<br>2.Perioperative blood loss (Estimated Blood Loss (EBL) in mL by the operating team).<br>3.Operation time.(Time from ‘incision’ to ‘end of surgery’ in minutes as reported in the EPD)<br>