Back to resultsIntra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
Primary Purpose
Reduction of Peroperative Blood Loss During Liver Resection
Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Intrahepatic division of the right hepatic vein.
Extrahepatic vein division
Sponsored by
About this trial
This is an interventional prevention trial for Reduction of Peroperative Blood Loss During Liver Resection focused on measuring Liver surgery, Blood loss, CUSA, Hepatic transection
Eligibility Criteria
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
Sites / Locations
- Department of Surgery Gastrocentrum Karolinska Univeristy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Extrahepatic vein division
Intrahepatic vein division
Arm Description
Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA.
Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA and intrahepatic division of the right hepatic vein.
Outcomes
Primary Outcome Measures
Intraoperative bloodloss
Secondary Outcome Measures
Operation time, postoperative complication rate
postoperative complication rate
Full Information
NCT ID
NCT02041078
First Posted
October 9, 2013
Last Updated
February 17, 2017
Sponsor
Karolinska University Hospital
Collaborators
Jansson, Anders, M.D., Bengt Isaksson
1. Study Identification
Unique Protocol Identification Number
NCT02041078
Brief Title
Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
Official Title
Randomized Phase 2 Study of Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Jansson, Anders, M.D., Bengt Isaksson
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intrahepatic division of the hepatic vein is associated with less blood loss than extrahepatic dissection and division of the right hepatic vein.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduction of Peroperative Blood Loss During Liver Resection
Keywords
Liver surgery, Blood loss, CUSA, Hepatic transection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extrahepatic vein division
Arm Type
Placebo Comparator
Arm Description
Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA.
Arm Title
Intrahepatic vein division
Arm Type
Experimental
Arm Description
Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA and intrahepatic division of the right hepatic vein.
Intervention Type
Procedure
Intervention Name(s)
Intrahepatic division of the right hepatic vein.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Extrahepatic vein division
Intervention Description
Standard surgical procedure with extrahepatic ligation/division of the right hepatic vein prior to parenchymal division with CUSA.
Primary Outcome Measure Information:
Title
Intraoperative bloodloss
Time Frame
Intraoperative time (in minutes) for the division of the liver parenchyma
Secondary Outcome Measure Information:
Title
Operation time, postoperative complication rate
Time Frame
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).
Title
postoperative complication rate
Time Frame
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Lundell, Professor
Organizational Affiliation
Gastrocentrum Karolinska University Hospital Huddinge, 141 86 Stockholm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery Gastrocentrum Karolinska Univeristy Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy
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