NCT02041078UnknownPhase 2
Randomized Phase 2 Study of Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
Karolinska University Hospital2 sites in 1 country100 target enrollmentStarted: May 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Intraoperative bloodloss
Study Overview
Brief Summary
Intrahepatic division of the hepatic vein is associated with less blood loss than extrahepatic dissection and division of the right hepatic vein.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hepatic lesion amenable to right sided hemihepatectomy.
Exclusion Criteria
- •Hepatic lesions not suitable for a anatomical right sided hemihepatectomy.
- •Unfit for surgery
- •Unwillingness to participate
Outcomes
Primary Outcomes
Intraoperative bloodloss
Time Frame: Intraoperative time (in minutes) for the division of the liver parenchyma
Secondary Outcomes
- postoperative complication rate(in hospital stay in days (on an average <30 days), total complication rate during hospital stay (on an average <30 days), surgical complications during in hospital stay (on an average <30 days).)
- Operation time, postoperative complication rate(Total time in minutes spent in theater, in hospital stay in days (on an average less than 30 days), total complication rate during hospital stay (on an average less than 30 days), surgical complications during in hospital stay (on an average<30days).)
Investigators
Lars Lundell
Professor
Karolinska University Hospital
Study Sites (2)
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