Multimodal Assessment of Liver Volume and Function

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: Colorectal Cancer; Liver Metastases
• Intervention / Treatment: Diagnostic test: Multimodal liver function assessment

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

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

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	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	HBS, MRI, CT and ICG performed 7 days after surgery	POD 7
Correlation between HBS and MRI in assessment of FLR function POD 28	HBS, MRI, CT and ICG performed 28 days after surgery	POD 28

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Study Chair: Magnus Nilsson, MD PhD, Karolinska Institutet

Study record dates

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

• Keywords: Chemotherapy; Liver function; Future liver remnant
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• 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