Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
Randomized Phase 2 Study of Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
1 other identifier
interventional
100
1 country
1
Brief Summary
Intrahepatic division of the hepatic vein is associated with less blood loss than extrahepatic dissection and division of the right hepatic vein.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFebruary 20, 2017
February 1, 2017
6.1 years
October 9, 2013
February 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraoperative bloodloss
Intraoperative time (in minutes) for the division of the liver parenchyma
Secondary Outcomes (2)
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).
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).
Study Arms (2)
Extrahepatic vein division
PLACEBO COMPARATORConventional right sided hemihepatectomy with division of the liver parenchyma with CUSA.
Intrahepatic vein division
EXPERIMENTALConventional right sided hemihepatectomy with division of the liver parenchyma with CUSA and intrahepatic division of the right hepatic vein.
Interventions
Ligation and division of the entrance of the right hepatic vein into the suprarenal cava vein are done at the end of transection of the liver parenchyma with CUSA.
Standard surgical procedure with extrahepatic ligation/division of the right hepatic vein prior to parenchymal division with CUSA.
Eligibility Criteria
You may qualify if:
- Hepatic lesion amenable to right sided hemihepatectomy.
You may not qualify if:
- Hepatic lesions not suitable for a anatomical right sided hemihepatectomy.
- Unfit for surgery
- Unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Jansson, Anders, M.D.collaborator
- Bengt Isakssoncollaborator
Study Sites (1)
Department of Surgery Gastrocentrum Karolinska Univeristy Hospital
Stockholm, 14186, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars Lundell, Professor
Gastrocentrum Karolinska University Hospital Huddinge, 141 86 Stockholm
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 9, 2013
First Posted
January 20, 2014
Study Start
May 1, 2011
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
February 20, 2017
Record last verified: 2017-02