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This study aims to explore an alternative method for assessing a participant's readiness for surgery, specifically for those undergoing surgery for gastric, oesophageal, or pancreatic cancer. Surgery for these diseases is extremely demanding on the body and surgeons need to be confident that a patient can tolerate the procedure.
Traditionally, participants undergo Cardiopulmonary Exercise Tests (CPET) to determine their fitness for surgery. This involves cycling on an exercise bike with increasing resistance until the resistance is too great to continue cycling at a constant rate. An individual's maximum rate of oxygen consumption (VO2max) and the anaerobic threshold (AT) are calculated during CPET and used by surgeons as a predictor for surgical fitness. CPET tests can be physically demanding for participants and are very resource intensive. Furthermore, some patients may not be able to tolerate exercise tests due to physical constraints.
An alternative method, Magnetic Resonance Spectroscopy (MRS), could be used to measure an individual's fitness prior to surgery. Within this study, MRS will be used to determine the levels of fat within the thigh muscle, which in turn may be able to be used to predict fitness for surgery.
The first phase includes recruiting participants on the surgical pathway. MRS will be performed as an additional examination, typically on the same day as the CPET. Fat levels determined from MRS will be compared with conventional CPET outcomes (VO2max and AT). This analysis aims to determine if MRS derived fat levels correlates with VO2max and AT and, if correlation is high, potentially providing an alternative to CPET for patients who cannot tolerate exercise tests.
The second phase involves recruiting volunteers who will undergo repeated MRS scans to assess the reliability of MRS methods. This process allows us to understand the consistency of MRS derived fat levels over both short and long-term intervals.
The potential benefits of this project include an additional pathway for assessing fitness for surgery or enhancing the presurgical pathway for patients by providing an alternative method for fitness assessment. This study aims to provide evidence that could present an alternative method of assessing a patient's fitness for surgery. The goal is to explore an alternative that may complement or refine current practices in preoperative assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | The first phase of the study will involve 56 participants who are potential candidates for oesophagectomy, gastrectomy or pancreaticoduodenectomy procedures following a confirmed cancer diagnosis. Participants who provide their consent will undergo Magnetic Resonance Spectroscopy (MRS) scans of their semitendinosus muscle in the thigh. Participants on this pathway also undergo Cardiopulmonary Exercise Test (CPET) tests, which is a standard procedure. No delay to their normal treatment pathway will be introduced from the addition of the MRS scan, and MR scans can be arranged within two weeks from referral |
| |
| Healthy volunteers | 25 healthy volunteers. Their role will be to help us understand the consistency in Intra-Myocellular Liquid (IMCL) composition using Magnetic Resonance Spectroscopy (MRS) techniques. These volunteers will be sourced from the UHNM Trust staff, in accordance with Trust Standard Operating Procedure (SOP): The Safe Scanning of Volunteers in Magnetic Resonance Imagine (MRI). Each volunteer will undergo two MRS scans initially. All three MRS scans will be performed in a single session, with the session lasting about 20 minutes. Additionally, each volunteer will return for a single repeat session of MRS acquisition using the same MRI system and protocol, scheduled at two weeks after the initial scans |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRS scan | Diagnostic Test | Magnetic Resonance Spectroscopy scan on the thigh |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlations between levels | Calculate the correlation between the intramyocellular lipid (IMCL) saturation index and Cardiopulmonary Exercise Test (CPET) derived VO2max and Anaerobic Threshold (AT). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparisons between participants who did not suffer major morbidity | Compare the mean Intra-Myocellular Lipid (IMCL) saturation index for patients who suffered major morbidity after oesophagectomy, gastrectomy, or pancreaticoduodenectomy and compare this to the mean IMCL saturation index of those who did not suffer major morbidity. | 2 years |
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Inclusion Criteria:
Inclusion criteria for patients (cohort 1)
Inclusion criteria for staff volunteers (cohort 2)
Exclusion Criteria:
Exclusion criteria for patients (cohort 1)
Exclusion criteria for staff volunteers (cohort 2)
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Cohort 1: Participants with oesophageal, gastric or pancreatic cancer who are potential candidates for surgical resection (oesophagectomy/gastrectomy/pancreaticoduodenectomy).
Cohort 2: Healthy volunteers who are UHNM staff members ≥ 18 years old, with no known contraindication to MRI. Volunteers will be age and gender matched to the participants in cohort 1.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aviva Ogbolosingha | Contact | 01782 675380 | aviva.ogbolosingha@uhnm.nhs.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of North Midlands NHS Trust | Recruiting | Stoke-on-Trent | United Kingdom |
Participant data will not be shared
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| CPET | Diagnostic Test | Cardiopulmonary Exercise Test |
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| Short and long term repeatability |
Assess the short- and long-term repeatability of Magnetic Resonance Spectroscopy (MRS) of Intra-Myocellular Lipid (IMCL) saturation index measurements in healthy volunteers. . |
| 2 years |
| Difference in IMCL composition | Assess the difference in Intra-Myocellular Lipid (IMCL) composition between patients considered for surgery and age and gender matched volunteers | 2 years |