Surgery Clinical Trial
— HepaticaOfficial title:
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
Verified date | October 2019 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This observational clinical cohort study aims to evaluate the clinical utility of LiverMultiScan in quantifying liver health prior to liver resection or TACE. The results will enable further developments in scanning protocols and software, and clearly define the relevance of applying this technology as part of the pre-operative assessment of the patient being considered for liver resection or TACE.
Status | Completed |
Enrollment | 149 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients being considered for liver resection Exclusion Criteria: - i. Patients under the age of 18 years will be excluded from the present study. ii. Prisoners will be excluded from the present study. iii. Persons unable to have an MRI scan (including but not limited to claustrophobia, implanted metallic devices, metal foreign body) iv. Adults with incapacity v. Non-provision of consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hampshire Hospitals Foundation Trust | Basingstoke | |
United Kingdom | NHS Lothian Royal Infirmary of Edinburgh | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | Hampshire Hospitals NHS Foundation Trust, Perspectum Diagnostics Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between the pre-operative liver health assessment score and the post-operative liver function composite integer-based risk score. | Correlation between the pre-operative liver health assessment score (Hepatica score - calculated by weighting future remnant liver volume by liver inflammation and fibrosis (LIF) score) and the post-operative liver function composite integer-based risk (Hyder-Pawlik) score. | 24 months | |
Secondary | To compare LiverMultiScan image interpretations with histological findings | To compare LiverMultiScan image interpretations with clinical outcome after surgery in three domains: post-operative liver function, surgery-specific complication rate, and overall complication rate | 24 months | |
Secondary | • To evaluate LiverMultiScan image interpretations correlated with post-operative length of stay. | • To compare LiverMultiScan image interpretations with histological findings in the resected liver specimen in four domains: fibrosis, inflammation, fat content and iron load as title | 24 months |
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