Multimodal Assessment of Liver Volume and Function
November 25, 2019 updated by: Ernesto Sparrelid, Karolinska University Hospital
Multimodal Assessment of Liver Volume and Function in Patients With Colorectal Liver Metastases
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
10
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
-
-
-
Stockholm, Sweden
- Karolinska University Hospital
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy
Description
Inclusion Criteria:
- CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy
Exclusion Criteria:
-
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?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between HBS and MRI in assessment of FLR function preop
Time Frame: Preop
|
HBS, MRI, CT and ICG performed the day before surgery
|
Preop
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between HBS and MRI in assessment of FLR function POD 7
Time Frame: POD 7
|
HBS, MRI, CT and ICG performed 7 days after surgery
|
POD 7
|
|
Correlation between HBS and MRI in assessment of FLR function POD 28
Time Frame: POD 28
|
HBS, MRI, CT and ICG performed 28 days after surgery
|
POD 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Magnus Nilsson, MD PhD, Karolinska Institutet
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 Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
April 28, 2017
First Submitted That Met QC Criteria
May 3, 2017
First Posted (Actual)
May 4, 2017
Study Record Updates
Last Update Posted (Actual)
November 26, 2019
Last Update Submitted That Met QC Criteria
November 25, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Liver fx study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.