Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy

February 17, 2017 updated by: Lars Lundell, Karolinska University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Department of Surgery Gastrocentrum Karolinska Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Extrahepatic vein division
Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA.
Procedure: Extrahepatic vein division
Standard surgical procedure with extrahepatic ligation/division of the right hepatic vein prior to parenchymal division with CUSA.
EXPERIMENTAL: Intrahepatic vein division
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
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
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Bengt Isaksson
Jansson, Anders, M.D.

Investigators

  • Principal Investigator: Lars Lundell, Professor, Gastrocentrum Karolinska University Hospital Huddinge, 141 86 Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

January 17, 2014

First Posted (ESTIMATE)

January 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/563-31/2 (OTHER: Ethic committee at Karolinska Institutet Stockholm Sweden)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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