Accuracy and Reliability of GSA for Remnant Liver Function (GSA)

December 11, 2013 updated by: Takehiro Okabayashi, Kochi University

Accuracy and Reliability of GSA for Remnant Liver Function in Scheduled Hepatectomized Patients

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.

Study Overview

Status

Status

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Available

Conditions

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Intervention / Treatment

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Detailed Description

99mTc-galactosyl human serum albumin (99mTc-GSA) single-photon emission CT (SPECT) was developed to facilitate investigations of regional hepatic function. A disadvantage of conventional 99mTc-GSA SPECT was poor anatomical resolution, and this newly developed SPECT has a tremendously improved anatomical resolution owing to the fusion of CT and 99mTc-GSA SPECT. Recent reports have indicated that accurate regional function, based on precise anatomical information, could be evaluated using this technique.

Study Type

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Expanded Access

Contacts and Locations

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Study Contact

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  • Name: Yasuo Shima
  • Phone Number: +81 88-837-3000

Study Locations

  • Japan
      • Kochi, Japan, 781-0111
        • Available
        • Kochi Health Sciences Center

Participation Criteria

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Eligibility Criteria

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Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.

Study Plan

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How is the study designed?

Collaborators and Investigators

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Sponsor

Sponsor

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Kochi University

Investigators

Investigators

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  • Study Chair: Yasuo Shima, MD PhD, Kochi Health Sciences Center

Publications and helpful links

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General Publications

Study record dates

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Study Registration Dates

First Submitted

First Submitted

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December 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2013

First Posted (Estimate)

First Posted

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December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

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December 17, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GSA-KHSC
  • GSA study (Other Grant/Funding Number: Kochi Organization for Medical Reformation and Renewal)

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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