Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy

Study Overview
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Brief Summary
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Intrahepatic division of the hepatic vein is associated with less blood loss than extrahepatic dissection and division of the right hepatic vein.

Official Title
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Randomized Phase 2 Study of Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy

Conditions
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Reduction of Peroperative Blood Loss During Liver Resection

Intervention / Treatment
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* Procedure: Intrahepatic division of the right hepatic vein.
* Procedure: Extrahepatic vein division


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Extrahepatic vein division<br>Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA. | Procedure: Extrahepatic vein division<br>* Standard surgical procedure with extrahepatic ligation/division of the right hepatic vein prior to parenchymal division with CUSA.<br>|
| Experimental: Intrahepatic vein division<br>Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA and intrahepatic division of the right hepatic vein. | Procedure: Intrahepatic division of the right hepatic vein.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative bloodloss |  | Intraoperative time (in minutes) for the division of the liver parenchyma | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver surgery, Blood loss, CUSA, Hepatic transection