Development of an intraoperative detection system for bile leakage after hepatectomy with indocyanine green

JRCT ID: jRCTs061210043

Registered date:13/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary hepatic cancer, metastatic hepatic cancer, benign hepatic tumor
• Date of first enrollment: 15/11/2021
• Target sample size: 85
• Study type: Interventional
• Intervention(s): ICG administration

Outcome(s)

• Primary Outcome: Total bilirubin concentration in drainage on the 3rd postoperative day

Secondary Outcome

1) Incidence of bile leakage after hepatectomy
2) The number of bile leaks after hepatectomy
3) Changes in total bilirubin concentration and total bilirubin amount per 24 hours in drainage
4) Bacteria in drainage
5) Duration of postoperative hospital stay
6) Safety

Key inclusion & exclusion criteria

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

Include criteria

[Study drug treatment group]
1) Patients undergoing hepatectomy as scheduled surgery for primary hepatic cancer, metastatic hepatic cancer, and benign hepatic tumor, regardless of laparotomy or laparoscopic surgery
2) ECOG-PS<=1
3) Male and female over 20 years old at the time of consent form
4) Patients without serious complications

[Historical control group]
1) Patients who underwent hepatectomy and drained for primary hepatic cancer, metastatic hepatic cancer, and benign hepatic tumor before July 2020, regardless of laparotomy or laparoscopic surgery
2) ECOG-PS<=1
3) Male and female over 20 years old at the time of surgery
4) Patients without serious complications

Exclude criteria

[Study drug treatment group]
1) Patients undergoing emergency surgery
2) Patients with a history of hypersensitivity to ICG components
3) Patients with a history of iodine hypersensitivity
4) Pregnant women or patients who may be pregnant
5) Lactating patients
6) Patients who participated in other clinical studies within 3 months before registration

[Historical control group]
1) Patients undergoing emergency surgery
2) Patients who received ICG at the time of surgery

Related Information

• Primary Sponsor: Hanaki Takehiko