Colorectal CancerNCT03140917
Multimodal Assessment of Liver Volume and Function
An observational study of Colorectal Cancer and Liver Metastases, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- What is being tested?
- Multimodal liver function assessment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2016to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy
Who may be able to join
- CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Colorectal Cancer, Liver Metastases
- Being tested
- Multimodal liver function assessment
- Keywords
- Liver function, Future liver remnant, Chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal liver function assessmentDiagnostic test
HBS, MRI, CE-CT and ICG
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between HBS and MRI in assessment of FLR function preop
HBS, MRI, CT and ICG performed the day before surgery
Measured: Preop
Secondary outcomes (2)
Correlation between HBS and MRI in assessment of FLR function POD 7
HBS, MRI, CT and ICG performed 7 days after surgery
Measured: POD 7
Correlation between HBS and MRI in assessment of FLR function POD 28
HBS, MRI, CT and ICG performed 28 days after surgery
Measured: POD 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startApr 2016
- Primary completionJun 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesto Sparrelid, Karolinska University Hospital
- Investigators
- Magnus Nilsson, MD PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140917
- Sponsor's protocol ID
- Liver fx study
- Status last verified
- Nov 2019
- First submitted
- 28 Apr 2017
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of Liver Volume and Function in Patients With Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT03140917
- Acronym / sponsor ID
- Liver fx study
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- Liver function, Future liver remnant, Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy
Key inclusion criteria (1 listed)
- CRLM treated with neoadjuvant chemotherapy subjected to right hepatectomy
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal liver function assessmentHBS, MRI, CE-CT and ICG | Diagnostic test | – |
Primary outcome
Correlation between HBS and MRI in assessment of FLR function preop
Time frame: Preop
HBS, MRI, CT and ICG performed the day before surgery
2 secondary outcomes
Correlation between HBS and MRI in assessment of FLR function POD 7
Time frame: POD 7
Correlation between HBS and MRI in assessment of FLR function POD 28
Time frame: POD 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Nilsson, MD PhD study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Liver Metastases, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between HBS and MRI in assessment of FLR function preop (time frame: Preop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.