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Multimodal Assessment of Liver Volume and Function

Sponsor
Karolinska University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03140917
Collaborator
(none)
10
Enrollment
1
Location
39
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Multimodal liver function assessment

Study Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Multimodal Assessment of Liver Volume and Function in Patients With Colorectal Liver Metastases
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Outcome Measures

Primary Outcome Measures

  1. Correlation between HBS and MRI in assessment of FLR function preop [Preop]

    HBS, MRI, CT and ICG performed the day before surgery

Secondary Outcome Measures

  1. Correlation between HBS and MRI in assessment of FLR function POD 7 [POD 7]

    HBS, MRI, CT and ICG performed 7 days after surgery

  2. Correlation between HBS and MRI in assessment of FLR function POD 28 [POD 28]

    HBS, MRI, CT and ICG performed 28 days after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska University Hospital Stockholm Sweden

Sponsors and Collaborators

  • Karolinska University Hospital

Investigators

  • Study Chair: Magnus Nilsson, MD PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ernesto Sparrelid, MD PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT03140917
Other Study ID Numbers:
  • Liver fx study
First Posted:
May 4, 2017
Last Update Posted:
Nov 26, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ernesto Sparrelid, MD PhD, Karolinska University Hospital
Liver function
Future liver remnant
Chemotherapy
Additional relevant MeSH terms:
Neoplasm Metastasis

Study Results

No Results Posted as of Nov 26, 2019