NCT02013895

Brief Summary

Preoperative evaluation of future remnant liver function is critical for patients undergoing hepatic surgery. Overestimation of the remnant liver function can lead to life-threatening postoperative hepatic failure, and its underestimation can lead to a lost opportunity for potentially curative surgery. Conventionally, post-hepatectomy remnant liver function has been estimated preoperatively using computed tomography (CT) volumetry. CT can provide precise anatomical information, and the remnant liver volume, measured by CT volumetry, has been reported to be an effective predictor of hepatic dysfunction after hepatectomy. However, the indirect estimation of liver function by CT volumetry is reliable only when the function is assumed to be homogenous over the whole liver.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

First QC Date

December 9, 2013

Last Update Submit

December 11, 2013

Conditions

Both Benign and Malignant Liver Mass

Keywords

liversurgeryliver functionGSAICG

Interventions

99mTc-GSADEVICE

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All eligible patients were those surgically treated for hepato-biliary diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kochi Health Sciences Center

Kochi, Kochi, 781-0111, Japan

AVAILABLE

Related Publications (1)

  • Okabayashi T, Shima Y, Morita S, Shimada Y, Sumiyoshi T, Sui K, Iwata J, Iiyama T. Liver Function Assessment Using Technetium 99m-Galactosyl Single-Photon Emission Computed Tomography/CT Fusion Imaging: A Prospective Trial. J Am Coll Surg. 2017 Dec;225(6):789-797. doi: 10.1016/j.jamcollsurg.2017.08.021. Epub 2017 Sep 11.

    PMID: 28912030DERIVED

Study Officials

  • Yasuo Shima, MD PhD

    Kochi Health Sciences Center

    STUDY CHAIR

Central Study Contacts

Takehiro Okabayashi, MD PhD

CONTACT

+81 88-837-3000takehiro_okabayashi@khsc.or.jp

Yasuo Shima

CONTACT

+81 88-837-3000

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Gastroenterological Surgery

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 17, 2013

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

JP(1)