Clinical trial NCT05831488: Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer
Official title: Assessing the Accuracy of Seismofit® as an Estimate of VO2 Peak in Patients With Hepato-pancreato-biliary, Colorectal, and Gastro-oesophageal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepato-Biliary Carcinoma in Situ Nos
Pancreatic Cancer
Colorectal Cancer
Gastric Cancer
Oesophageal Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All HPB, gastro-oesophageal or colorectal cancer patients undergoing preoperative assessment for major surgery

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: End of Trial (9 months)
Secondary outcomes:
measure: Assess limits of agreement and bias between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak
timeFrame: End of Trial (9 months)
measure: Assess the relationship between Seismofit®-estimated VO2 peak and CPET-measured VO2 peak in each surgical subgroup: HPB, gastro-oesophageal and colorectal cancer patients.
timeFrame: End of Trial (9 months)
measure: 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)
timeFrame: End of Trial (9 months)
measure: Assess patient experience of the Seismofit® test using a brief measure that has been used previously in CPET research
timeFrame: End of Trial (9 months)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
References: