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

Phase 2

• Conditions: hepatic tumors; hepatic tumor, hepatic neoplasma; D008113

• Registration Number: JPRN-jRCT1051180070
• Lead Sponsor: Kido Masahiro

Brief Summary

The ICG-fluorescence imaging was performed on 47 cases. The border of the hepatic segments were successfully identified in 28 cases (59.6%).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-19
• Study Completion: 2021-10-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 47

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the success and failure of identifying hepatic segments using the ICG-fluorescence imaging system

Secondary Outcome Measures

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