NCT03140917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

3.2 years

First QC Date

April 28, 2017

Last Update Submit

November 25, 2019

Conditions

Colorectal CancerLiver Metastases

Keywords

Liver functionFuture liver remnantChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Correlation between HBS and MRI in assessment of FLR function preop

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

    Preop

Secondary Outcomes (2)

  • Correlation between HBS and MRI in assessment of FLR function POD 7

    POD 7

  • Correlation between HBS and MRI in assessment of FLR function POD 28

    POD 28

Interventions

Multimodal liver function assessmentDIAGNOSTIC_TEST

HBS, MRI, CE-CT and ICG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy

You may qualify if:

  • CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Magnus Nilsson, MD PhD

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 4, 2017

Study Start

April 1, 2016

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)