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Oceanus OH study

An exploratory study of Hydrofit, an elastomeric sealant for managing of bleeding from hepatic vein during surgery, Open hepatectomy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042240183
Enrollment
20
Registered
2025-02-05
Start date
2025-05-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing open hepatectomy

Interventions

Sponsors

Sugiura Teiichi
Lead Sponsor

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 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

MeasureTime frame
Hemostasis achievement rate within 10 minutes from the start of hemostasis

Secondary

MeasureTime 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

Public ContactRyo Ashida

Shizuoka Cancer Center

r.ashida@scchr.jp+81-55-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026