Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability
NCT ID: NCT04270851
Last Updated: 2020-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2020-04-30
2021-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Borderline Resectability
Patients with colorectal liver metastases where the decision-making on technical resectability is difficult, i.e. 'borderline resectable,' where a group of liver surgeons might reasonably be expected to find the decision whether to operate to be challenging. A group of up to 20 such patients will undergo pre-operative LiMAx test and HepaT1ca pre-operative scanning. Recruited participants' data will be used to create anonymised online case scenarios to be used in a survey, assessing whether liver surgeons find these pre-operative assessments helpful in their decision-making on technical resectability.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Presence of any other serious uncontrolled medical condition
3. Patients under 16 years old
4. Contra-indications to magnetic resonance scanning
16 Years
ALL
No
Sponsors
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Manchester University NHS Foundation Trust
OTHER_GOV
Perspectum
INDUSTRY
The Christie NHS Foundation Trust
OTHER
The Royal College of Surgeons of England
OTHER
University of Manchester
OTHER
Responsible Party
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Kat Parmar
Clinical Research Fellow
Locations
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The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Countries
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References
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Parmar KL, O'Reilly D, Valle J, Braun M, Malcomson L, Jones RP, Balaa F, Rees M, Welsh FKS, Filobbos R, Renehan AG. Protocol for the CoNoR Study: A prospective multi-step study of the potential added benefit of two novel assessment tools in colorectal liver metastases technical resectability decision-making. BMJ Open. 2023 Mar 30;13(3):e059369. doi: 10.1136/bmjopen-2021-059369.
Other Identifiers
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IRAS ID 266961
Identifier Type: -
Identifier Source: org_study_id
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