CPET and Outcome After Oesophagogastric Cancer Surgery

Summary

Primary Aim: The present study is a retrospective analysis of prospectively collected clinical data. Anonymized data from patients collected during routine clinical care from 9 units in the United Kingdom who undertake upper gastrointestinal (UGI) cancer surgery and perform pre-operative cardiopulmonary exercise testing will be interrogated. Data will be pooled at a central location (University Hospitals Southampton) and used to investigate the relationship between selected cardiopulmonary exercise testing (CPET) variables, in-hospital post-operative and survival outcomes after major UGI cancer surgery.

Rationale: Our primary aim is to establish a reliable relationship between post-operative survival (1 and 3 -year) and oxygen uptake (VO2) at peak exercise (VO2 Peak); a secondary aim is to explore the multivariable relationship between selected CPET variables especially VO2 at the estimated lactate threshold/anaerobic threshold (AT), together with other selected CPET derived variables, and other important prognostic variables with post-operative complications (morbidity and mortality) in an attempt to risk stratify patients before major UGI surgery.

Trial Design: Multicentre observational

Inclusion Criteria: We aim to include all patients aged \>18 years considered eligible by the MDT for major curative UGI cancer surgery and undergoing an enhanced recovery programme after surgery. Patients undergoing neoadjuvant chemotherapy or chemoradiotherapies will also be included. Patients having a CPET and initially scheduled for curative surgery, but end up not having surgery due to disease progression or other clinical reasons will be included and analysed separately.

Exclusion Criteria: Patients will be excluded if they are physically unable to perform a CPET on a cycle ergometer, patients having emergency surgery, patients lacking complete in-hospital morbidity or mortality data and patients undergoing preoperative exercise interventions.

Primary Trial Endpoints: 3 year overall survival

Conditions

• Upper Gastrointestinal Disorders

Interventions

DIAGNOSTIC_TEST

Cardiopulmonary exercise testing

The CPET involves cycling on an exercise bike for 8-12 minutes. Starting with a very low resistance on the pedals the patient will pedal at 60 revolutions per minute. After 3 minutes of cycling, the resistance will gradually increase until the patient can no longer turn the pedals at the required speed. The test will be thoroughly explained to the patient beforehand and trained staff will make the experience as comfortable as possible. CPETs will be stopped early by the study researcher/doctor in the presence of any adverse events. Each CPET appointment will last approximately one hour.

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• South Tees Hospitals NHS Foundation Trust

  collaborator OTHER

• University Hospital Plymouth NHS Trust

  collaborator OTHER

• Lancashire Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Liverpool University Hospitals NHS Foundation Trust

  collaborator OTHER_GOV

• University Hospitals, Leicester

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  lead OTHER

Principal Investigators

• Denny Levett, PhD · University Hospitals Southampton NHS Foundation Trust

• Malcolm West, PhD · University Hospitals Southampton NHS Foundation Trust

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-01

Primary Completion

2021-01-01

Completion

2022-03-01

Countries

• United Kingdom

Study Locations