Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy

Phase 2

• Conditions: Reduction of Peroperative Blood Loss During Liver Resection
• Interventions: Procedure: Extrahepatic vein division; Procedure: Intrahepatic division of the right hepatic vein.

• Registration Number: NCT02041078
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extrahepatic vein division	Extrahepatic vein division	Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA.
Intrahepatic vein division	Intrahepatic division of the right hepatic vein.	Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA and intrahepatic division of the right hepatic vein.

Primary Outcome Measures

Name	Time	Method
Intraoperative bloodloss	Intraoperative time (in minutes) for the division of the liver parenchyma

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Department of Surgery Gastrocentrum Karolinska Univeristy Hospital; 🇸🇪 Stockholm, Sweden