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Accuracy and Reliability of GSA for Remnant Liver Function

NCT ID: NCT02013895

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Both Benign and Malignant Liver Mass

Keywords

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liver surgery liver function GSA ICG

Interventions

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99mTc-GSA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All eligible patients were those surgically treated for hepato-biliary diseases.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kochi University

OTHER

Sponsor Role lead

Responsible Party

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Takehiro Okabayashi

Department of Gastroenterological Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasuo Shima, MD PhD

Role: STUDY_CHAIR

Kochi Health Sciences Center

Locations

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Kochi Health Sciences Center

Kochi, Kochi, Japan

Site Status AVAILABLE

Countries

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Japan

Central Contacts

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Takehiro Okabayashi, MD PhD

Role: CONTACT

Phone: +81 88-837-3000

Email: [email protected]

Yasuo Shima

Role: CONTACT

Phone: +81 88-837-3000

Facility Contacts

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Takehiro Okabayashi, MD PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 28912030 (View on PubMed)

Other Identifiers

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GSA study

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GSA-KHSC

Identifier Type: -

Identifier Source: org_study_id