Colorectal Cancer, Gastric Cancer, Hepato-Biliary Carcinoma in Situ Nos, Oesophageal Cancer, Pancreatic Cancer
Conditions
Brief summary
Our study aims to assess the relationship between the Seismofit® derived VO2 peak estimate and CPET-measured VO2 peak in patients who are having CPET as part of their preoperative workup. Our aim is to establish whether Seismofit® can be considered a cheaper, less resource intensive and better tolerated alternative to the CPET, or whether it might be useful as a screening tool to efficiently identify patients with exercise intolerance who may benefit from further characterisation by CPET.
Interventions
OTHERNon-Interventional
Non Interventional
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 2. Scheduled for elective surgery for resection of HPB, colorectal or gastro-oesophageal primary or secondary cancer 3. Undergoing CPET as part of routine pre-operative investigations
Exclusion criteria
1. Subjects unable to give voluntary written informed consent to participate in this study 2. Diagnosis of moderate or worse stenosis or regurgitation of any cardiac valve 3. Previous aortic or mitral valve surgery, valvuloplasty or transcatheter valve implantation 4. Permanent pacemaker or cardiac resynchronisation device in situ 5. Diagnosis of severe pulmonary hypertension 6. Permanent atrial fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative assessment for major surgery. | End of Trial (9 months) | Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak | End of Trial (9 months) | Limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak (Bland-Alman analysis) |
| Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients. | End of Trial (9 months) | Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and CPET-measured VO2 peak, as well as limits of agreement and bias (Bland-Altman analysis) in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients. |
| Assess the relationship between Seismofit® -estimated VO2 peak and other CPET derived variables: o Anaerobic Threshold (AT) o Peak Power Output (PPO) o Ventilatory equivalents for carbon dioxide (VE/VCO2) | End of Trial (9 months) | Strength and direction of relationship (Pearson correlation coefficient) between Seismofit® -estimated VO2 peak and the CPET-measured variables of AT, PPO and VE/VCO2 |
| Assess patient experience of the Seismofit® test using a brief measure that has been used previously in CPET research | End of Trial (9 months) | Patient concern, comfort, and overall satisfaction of Seismofit® measurement compared with CPET. |
Countries
United Kingdom
Outcome results
None listed