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| Name | Class |
|---|---|
| Manchester University NHS Foundation Trust | OTHER_GOV |
| Perspectum | INDUSTRY |
| The Christie NHS Foundation Trust | OTHER |
| The Royal College of Surgeons of England |
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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).
The CoNoR Study will occur via 4 workstreams:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiMAx test | Diagnostic Test | The LiMAx test is a fully licenced liver function test, testing liver maximum capacity via a breath test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with histologically verified adenocarcinoma of the colon or rectum and radiological evidence of liver metastases
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christie NHS Foundation Trust | Manchester | Greater Manchester | M20 4NX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36997247 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
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| OTHER |
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| HepaT1ca magnetic resonance scan | Diagnostic Test | The HepaT1ca scan is a pre-operative magnetic resonance scan providing a detailed report permitting interactive virtual pre-operative planning prior to liver surgery. |
|
| One Year |
| 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 |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |