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Ipsilateral Hepatic Vein Embolization After Portal Vein Embolization

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ClinicalTrials.gov Identifier: NCT00698880
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 17, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

Portal vein embolization (PVE) induces shrinkage of the embolized lobe and compensatory enlargement of the non-embolized lobe, but it does not always induce sufficient liver regeneration. There was no effective method to accelerate liver regeneration in addition to PVE yet.

This study intends to assess the effect of ipsilateral hepatic vein embolization (HVE) performed after Portal vein embolization (PVE) on liver regeneration. During a 1-year study period, preoperative HVE would be performed on 10 or more patients who had shown limited liver regeneration after PVE awaiting right hepatectomy. Sequential application of PVE and HVE may be safe and effective in facilitating contralateral liver regeneration by inducing more severe liver damage than PVE alone.


Condition or disease Intervention/treatment Phase
Procedure-Related Complication Degree of Liver Regeneration Procedure: Right hepatic vein embolization Phase 2 Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Preoperative Ipsilateral Hepatic Vein Embolization After Portal Vein Embolization to Induce Further Liver Regeneration in Patients With Hepatobiliary Malignancy
Study Start Date : March 2007
Primary Completion Date : February 2008
Study Completion Date : April 2008
Arms and Interventions

Arm Intervention/treatment
Active Comparator: HVE
Hepatic vein embolization after portal vein embolization
Procedure: Right hepatic vein embolization
Embolization of the right hepatic vein
Other Name: Sequential right hepatic vein embolization
No Intervention: PVE
Only portal vein embolization, historical control group


Outcome Measures

Primary Outcome Measures :
  1. Future remnant left liver volume on multidetector dynamic CT scans [ Time Frame: 2 weeks after HVE ]

Secondary Outcome Measures :
  1. Immunohistochemical stainings [ Time Frame: during operation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients showing small future remnant liver < 40% of whole liver volume

Exclusion Criteria:

  • Patients showing small future remnant liver > 40% of whole liver volume
  • Inoperable tumor extent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698880


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Shin Hwang, MD, PhD Department of Surgery, Asan Medical Center
More Information

Responsible Party: Shin Hwang, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00698880     History of Changes
Other Study ID Numbers: Preop_PVE_HVE
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by Asan Medical Center:
Portal vein embolization
Hepatic vein embolization
Liver regeneration