Real-time navigation during hepatectomy using fusion indocyanine green-fluorescence imaging

JRCT ID: jRCT1051180070

Registered date:19/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: hepatic tumors
• Date of first enrollment: 17/04/2018
• Target sample size: 100
• Study type: Interventional

Intervention(s)

1) ICG is injected intravenously at the maximum dose of 0.5 mg/kg body weight within 2 days preoperatively. Intraoperatively, we will initially observe the hepatic surface using a fusion ICG-fluorescence imaging system to detect liver tumours.
2) After identifying and clamping the portal pedicle corresponding to the hepatic segments to be removed, additional ICG is injected intravenously at a dose of 0.5 mg/kg body weight to identify the boundaries of the hepatic segments. Hepatectomy is performed based on the demarcation between fluorescing and non-fluorescing areas, which are assumed to be the boundaries of the hepatic segments.

Outcome(s)

• Primary Outcome: the success and failure of identifying hepatic segments using the ICG-fluorescence imaging system

Secondary Outcome

1) Tumor identification rate
2) operation time, bleeding, percentage of complications after hepatectomy
3) laboratory data(AST, ALT, albumin, total bilirubin, prothrombin time(%), platelet) at day1,3,5,and 7.
4) disease free survival
5) allergic incidence
6) percentage of complications due to insertion of near-infrared scope during surgery

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who satisfy all the following criteria are targeted.
1) male or female patients with liver tumours, aged 20 years and older
2) ability to understand the nature of the study procedures, and willingness to participate and give voluntary written consent
3) diagnosed as hepatic tumors by histolically or clinically
4) child pugh score is A or B and planned hepatic resection for hepatic tumror
5) no matter whether it is initial treatment

Exclude criteria

Patients applicable to even one of the following are excluded.
1) having clear iodine allergy
2) judged inappropriate by the doctor in charge of this clinical study.
3) showed hypersensitivity with indocyanine green when preoperative test

Related Information

• Primary Sponsor: Kido Masahiro
• Secondary ID(s): UMIN000031054