NCT04270851

Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability

Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability (The CoNoR Study)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University of Manchester · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Cancer Metastatic
• Colorectal Cancer
• Liver Metastasis Colon Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	LiMAx test	The LiMAx test is a fully licenced liver function test, testing liver maximum capacity via a breath test.
DIAGNOSTIC_TEST	HepaT1ca magnetic resonance scan	The HepaT1ca scan is a pre-operative magnetic resonance scan providing a detailed report permitting interactive virtual pre-operative planning prior to liver surgery.

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2020-02-17
• Last updated: 2020-02-17

Locations

1 site across 1 country: United Kingdom