Intra Versus Extrahepatic Division of Right Hepatic Vein During Rightsided Hemihepatectomy

NCT ID: NCT02041078

Last Updated: 2017-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2017-07-31

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.

Detailed Description

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Conditions

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Reduction of Peroperative Blood Loss During Liver Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Extrahepatic vein division

Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA.

Group Type PLACEBO_COMPARATOR

Extrahepatic vein division

Intervention Type PROCEDURE

Standard surgical procedure with extrahepatic ligation/division of the right hepatic vein prior to parenchymal division with CUSA.

Intrahepatic vein division

Conventional right sided hemihepatectomy with division of the liver parenchyma with CUSA and intrahepatic division of the right hepatic vein.

Group Type EXPERIMENTAL

Intrahepatic division of the right hepatic vein.

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Extrahepatic vein division

Standard surgical procedure with extrahepatic ligation/division of the right hepatic vein prior to parenchymal division with CUSA.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jansson, Anders, M.D.

INDIV

Sponsor Role collaborator

Bengt Isaksson

UNKNOWN

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Lundell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Lundell, Professor

Role: PRINCIPAL_INVESTIGATOR

Gastrocentrum Karolinska University Hospital Huddinge, 141 86 Stockholm

Locations

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Department of Surgery Gastrocentrum Karolinska Univeristy Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2011/563-31/2

Identifier Type: OTHER

Identifier Source: secondary_id

2011/563-31/2

Identifier Type: -

Identifier Source: org_study_id

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