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

Near-Infrared fluorescence imaging in open and laparoscopic hepatectomy: improving safety of the extra-glissionian approach? - FLASH pilot: Fluorescence Assisted Safer Hepatectomy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55781

Enrollment

Registered

2017-10-23

Start date

2017-12-14

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatic tumors

Interventions

The included patients will undergo NIRF-assisted liver surgery with the use of ICG. ICG will be administered 12-24 hours before surgery in a dose of 0,15mg/kg or just after induction of anesthesia i

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Age

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)