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NCT03140917 Clinical Trial

Multimodal Assessment of Liver Volume and Function

Colorectal Cancer Clinical Trial

Official title:
Multimodal Assessment of Liver Volume and Function in Patients With Colorectal Liver Metastases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03140917
Other study ID # Liver fx study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2016
Est. completion date July 2019

Study information
Verified date November 2019
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In liver surgery peroperative assessment och the future liver remnant (FLR) is pivotal in order to avoid posthepatectomy liver failure. To date this is mainly performed by measuring the volume of the FLR. Of course FLR volume acts as a surrogate measure of FLR function and the correlation between volume and function is not always accurate. Several techniques to assess FLR function has been proposed. Hepatobiliary scintigraphy (HBS) and Dynamic MRI are the two such methods. In this study we compare HBS and MRI, in addition to contrast-enhanced CT and ICG, repeatedly performed before and after right hepatectomy in patients with colorectal liver metastases treated with neoadjuvant chemotherapy.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date July 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy

Exclusion Criteria:

-

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Multimodal liver function assessment
HBS, MRI, CE-CT and ICG

Locations
Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between HBS and MRI in assessment of FLR function preop HBS, MRI, CT and ICG performed the day before surgery Preop
Secondary Correlation between HBS and MRI in assessment of FLR function POD 7 HBS, MRI, CT and ICG performed 7 days after surgery POD 7
Secondary Correlation between HBS and MRI in assessment of FLR function POD 28 HBS, MRI, CT and ICG performed 28 days after surgery POD 28
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