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Ipsilateral Hepatic Vein Embolization After Portal Vein Embolization

This study has been completed.
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00698880
First received: June 16, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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 Intervention Phase
Procedure-Related Complication
Degree of Liver Regeneration
Procedure: Right hepatic vein embolization
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Future remnant left liver volume on multidetector dynamic CT scans [ Time Frame: 2 weeks after HVE ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunohistochemical stainings [ Time Frame: during operation ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: March 2007
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Shin Hwang, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00698880     History of Changes
Other Study ID Numbers: Preop_PVE_HVE
Study First Received: June 16, 2008
Last Updated: June 16, 2008
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014