Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability

Cancer Clinical Trial

— CoNoR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04270851
• Other study ID #: IRAS ID 266961
• Status: Not yet recruiting
• Start date: April 2020
• Est. completion date: March 2021

Study information

• Verified date: February 2020
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cancer Metastatic
• Colorectal Cancer
• Liver Metastasis Colon Cancer
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Diagnostic Test:
• LiMAx test
The LiMAx test is a fully licenced liver function test, testing liver maximum capacity via a breath 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.

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester	Greater Manchester

Sponsors (5)

Lead Sponsor	Collaborator
University of Manchester	Manchester University NHS Foundation Trust, Perspectum Diagnostics Ltd, The Christie NHS Foundation Trust, The Royal College of Surgeons of England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in decision making on technical resectability	Liver surgeons will view the standard pre-operative assessment results and decide if each case scenario is 'technically resectable.' They will then view the results from these two additional pre-operative tests (LiMAx and HepaT1ca), and decide again. We will measure for any change in decision making after viewing the novel test results.	One year
Secondary	Change in operative plan	Liver surgeons will view the standard pre-operative assessment results and specify their operative plan for each clinical scenario. They will then view the results from these two additional pre-operative tests (LiMAx and HepaT1ca), and specify their operative plan again. We will measure for any change in decision making in their operative plan after viewing the novel test results.	One Year
Secondary	Level of agreement between liver surgeons on technical resectability	For all participating surgeons, we will measure the level of agreement between them when they decide if each case scenario is technically resectable.	One Year