Patients undergoing open hepatectomy
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age at the time of consent is older than 18 years old. 2) ECOG performance status (PS) is 0 or 1. 3) Surgical treatment is scheduled within 2 weeks of obtaining consent. 4) Scheduled for open hepatectomy. 5) Major organ functions are preserved. 6) Written informed consent has been obtained after sufficient explanation of the trial details before enrollment in this study.
Exclusion criteria
Exclusion criteria: (1) Patients with localized infections requiring intervention or active systemic infections. (2) Pregnant women, nursing mother, patients with possibility of pregnant, or patients unwilling to use contraception during the study period. (3) Patients with a history of disorders associated with coagulation abnormalities. (4) Patients with clinically significant psychiatric disorders that would preclude enrollment in the study. (5) Patients receiving continuous administration of steroids or immunosuppressive agents. (6) Patients with a history of severe hypersensitivity. (7) Patients deemed inappropriate by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostasis achievement rate within 10 minutes from the start of hemostasis | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve hemostasis Percentage of hemostasis achieved after 15 minutes Percentage of additional hemostatic treatment required Amount of Hydrofit used Intraoperative complications Percentage of postoperative rebleeding Duration of drainage Drainage volume Number of days of postoperative hospital stay Postoperative adverse events within 30 days | — |
Contacts
Shizuoka Cancer Center