Primary hepatic cancer, metastatic hepatic cancer, benign hepatic tumor
Conditions
Interventions
Sponsors
Hanaki Takehiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total bilirubin concentration in drainage on the 3rd postoperative day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of bile leakage after hepatectomy 2) Drainage/serum concentration ratio of total bilirubin on the third postoperative day 3) The number of bile leaks after hepatectomy 4) Changes in total bilirubin concentration and total bilirubin amount per 24 hours in drainage 5) Bacteria in drainage 6) Duration of postoperative hospital stay 7) Safety | — |
Contacts
Public ContactTakehiko Hanaki
Tottori University Hospital
Outcome results
None listed