Clinical trial NCT04270851: Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability
Official title: Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability (The CoNoR Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Cancer Metastatic
Colorectal Cancer
Liver Metastasis Colon Cancer
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
name: Perspectum
name: The Christie NHS Foundation Trust
name: The Royal College of Surgeons of England
First posted: 2020-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically verified adenocarcinoma of the colon or rectum and radiological evidence of liver metastases

Brief summary: The CoNoR study aims to assess whether the use of the LiMAx test and the HepaT1ca pre-operative planning magnetic resonance scan impact upon technical resectability decision-making in colorectal liver metastases (CLM).

Detailed description: The CoNoR Study will occur via 4 workstreams:

1. Systematic review of all published criteria for colorectal liver metastases (CLM) technical resectability (systematic review protocol published on PROSPERO database: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=136748
2. Expert interviews: Interviews with liver surgeons and radiologists to assess current standard practice in CLM technical resectability decision-making and role for novel assessment tools
3. Online questionnaire: Online international questionnaire of liver surgeons to assess current standard practice in CLM technical resectability decision-making and role for novel assessment tools, in additional to identifying clinical scenarios in which these tools may be of greatest benefit
4. Online case-based survey: Recruitment of 10-20 participants with 'difficult decisions' regarding technical resectability, and consent to use results from pre-operative assessments to create anonymised online case-based survey. Participants will consent to have two additional pre-operative assessments: the LiMAx tests and the HepaT1ca magnetic resonance scan. These results from these additional tests will also be used in the online survey, We will recruit international liver surgeons to complete this online survey, where they will be asked to provide an opinion on technical resectability for each individual case scenario, and to specify their operative plan, both before and after seeing the results of these novel assessment tools. We will assess for change in decision-making on resectability, and change in operative plan after seeing these test results. We will also assess for level of agreement between liver surgeons on each scenario, and identify where they difficult decisions persist.

Eligibility criteria: Inclusion Criteria:

1. Patients over 16 years of age with histologically verified adenocarcinoma of the colon or rectum and radiological evidence of liver metastases
2. Discussion at regional hepatobiliary multidisciplinary team meeting
3. Hepatobiliary surgical opinion that their case represents a potentially difficult decision regarding technical resectability
4. Ability to provide written informed consent

Exclusion Criteria:

1. Presence of a medical or psychiatric condition impairing the ability to give informed consent
2. Presence of any other serious uncontrolled medical condition
3. Patients under 16 years old
4. Contra-indications to magnetic resonance scanning

Primary outcomes:
measure: Change in decision making on technical resectability
timeFrame: One year
Secondary outcomes:
measure: Change in operative plan
timeFrame: One Year
measure: Level of agreement between liver surgeons on technical resectability
timeFrame: One Year
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
Study officials:
References: