A patient undergoing laparoscopic hepatectomy.
Conditions
Interventions
In cases where there is oozing bleeding observed on the cut surface of the liver while hemostasis cannot achieved with electrocautery, apply an appropriate amount of PuraStat 5mL to the site of oozing
Sponsors
Sugiura Teiichi
Eligibility
Sex/Gender
All
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 laparoscopic 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. (Patients with coagulopathy or unable to withdraw antiplatelet or anticoagulant drugs) (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 hypersensitivity to peptide or protein preparations. (7) Patients with a history of severe hypersensitivity. (8) Patients deemed inappropriate by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of hemostasis achieved in 3 minutes from the start of hemostasis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve hemostasis Percentage of hemostasis achieved in 5 minutes Percentage of hemostasis achieved in 10 minutes Percentage of additional hemostatic treatment required Time required for prepare PuraStat Amount of PuraStat used Intraoperative complications Percentage of postoperative rebleeding Duration of drainage Drainage volume Postoperative hospital stay Adverse events within 30 days after surgery | — |
Contacts
Public ContactRyo Ashida
Shizuoka Cancer Center
Outcome results
None listed