ear-Infrared fluorescence imaging in open and laparoscopic hepatectomy: improving safety of the extra-glissionian approach?

Recruiting

Conditions: hepatic tumors
10019654
10019818

Registration Number: NL-OMON55781

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Male or female patients, aged 18 years and above
- Scheduled for elective segment resection or hemi-hepatectomy
- Normal renal function (eGFR>45)
- No known hypersensitivity for iodine or ICG
- No hyperthyroidism
- Able to understand the nature of the study procedures
- Willing to participate and give written informed consent

Exclusion Criteria

- Age < 18 years
- Renal insufficiency (eGFR<45)
- Known ICG, iodine, penicillin or sulpha hypersensitivity
- Pregnancy or breastfeeding
- Hyperthyroidism
- Not able to understand the nature of the study procedure
- i.v. heparin injection in the last 24h (LMWH not contraindicated)
- Not willing to participate

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The ability to visualize right, left hepatic ducts and the common hepatic duct<br /><br>simultaneously, with localization of the hepatic duct confluence duct using<br /><br>NIRF imaging. This will be scored by the operating surgeon before and after<br /><br>selective portal pedicle clamping using a scale from 1-5. In this scale; 1<br /><br>means no fluorescent signal visible, 2 some signal visible but very hard to<br /><br>see, up to 5 where there is a very clear fluorescent signal that provides<br /><br>excellent distinction between the biliary structures and the surroundings.<br /><br>Also, the target to background ratio will be calculated to quantify the<br /><br>fluorescence intensity of the cystic ducts compared to the liver. In this, the<br /><br>two arms will be compared (injection of ICG 24h before surgery versus during<br /><br>induction of anaesthesia) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Visibility of liver metastasis (also on a scale from 1 to 5);<br /><br>- Time between cholecystectomy and the surgeon being confident where to<br /><br>transect the hepatic duct;<br /><br>- Total surgical time, measured from incision until first stitch;<br /><br>- Bile duct injury;<br /><br>- Postoperative length of hospital stay (number of night admitted after<br /><br>surgery);<br /><br>- Complications due to the intravenously injected contrast agent;<br /><br>- Postoperative complications until 30 days after surgery.</p><br>