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

Available

Conditions

Intervention / Treatment

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

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kochi University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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