Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy

Reduction of Peroperative Blood Loss During Liver Resection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02041078
• Other study ID #: 2011/563-31/2
• Secondary ID: 2011/563-31/2
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: October 9, 2013
• Last updated: February 17, 2017
• Start date: May 2011
• Est. completion date: July 2017

Study information

• Verified date: February 2017
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Reduction of Peroperative Blood Loss During Liver Resection

Intervention

Procedure:
• Intrahepatic division of the right hepatic vein.
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.
• Extrahepatic vein division
Standard surgical procedure with extrahepatic ligation/division of the right hepatic vein prior to parenchymal division with CUSA.

Locations

Country	Name	City	State
Sweden	Department of Surgery Gastrocentrum Karolinska Univeristy Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska University Hospital	Bengt Isaksson, Jansson, Anders, M.D.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative bloodloss		Intraoperative time (in minutes) for the division of the liver parenchyma
Secondary	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).
Secondary	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).