CPET and Outcome After Oesophagogastric Cancer Surgery

NCT03637647 | Completed

• 1 other identifier: 17/SC/0331
• Study Type: observational
• Target: 611
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiopulmonary exercise testing; oesophagogastric; surgery; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Fitness

  Oxygen uptake at estimated lactate threshold

  up to 4 weeks before pre-surgery

Secondary Outcomes (1)

• Sarcopenia defined by skeletal muscle radiation attenuation

  up to 4 weeks before pre-surgery

Study Arms (1)

Upper gastrointestinal cancer

Upper gastrointestinal cancers including oesophagus and stomach

Diagnostic Test: Cardiopulmonary exercise testing

Interventions

Cardiopulmonary exercise testing DIAGNOSTIC_TEST

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.

Upper gastrointestinal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Upper gastrointestinal cancer patients

You may qualify if:

• We aim to include all patients aged \>18 years considered eligible by the MDT for major curative UGI cancer surgery
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Royal Surrey County Hospital NHS Foundation Trust: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• South Tees Hospitals NHS Foundation Trust: collaborator
• University Hospital Plymouth NHS Trust: collaborator
• Lancashire Teaching Hospitals NHS Foundation Trust: collaborator
• Liverpool University Hospitals NHS Foundation Trust: collaborator
• University Hospitals, Leicester: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

University Hospitals Southampton

Southampton, United Kingdom

Location

Related Publications (1)

• West MA, Rahman S, Jack S, Grocott MPW, Levett DZH; Perioperative Exercise Testing and Training Society (POETTS); Rashid Y, Griffiths J, Ezra M, Ayres L, Neville-Webbe H, Javed MS, Shrotri M, Khan I, Whitmore D, Prabhu P, Timbrell D, Allen S, Packham AO, Sharpe D, Anderson H, Minto G, McAleer S, McPhail S, Alasmar M, Hartley RA, Sultan J, Grace B, Underwood TJ, Byrne J, Noble F, Kelly J, Ansell G, Edwards M. Cardiopulmonary exercise variables and their association with postoperative morbidity and mortality after major oesophagogastric cancer surgery-a multicentre observational study. BJA Open. 2024 Jun 7;10:100289. doi: 10.1016/j.bjao.2024.100289. eCollection 2024 Jun.

  PMID: 38947220 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Denny Levett, PhD

  University Hospitals Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Malcolm West, PhD

  University Hospitals Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 20, 2018
• Study Start: June 1, 2012
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)