Oesophageal CancerNCT03216694
The Association Between Preoperative CPEX and Postoperative Morbidity Following Oesophagectomy
An observational study of Oesophageal Cancer, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
A retrospective hospital-based cohort study of the association between preoperative cardiopulmonary exercise test (CPEX) variables and short-term postoperative morbidity following oesophagectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- Cardiopulmonary exercise testing
- How many people
- 254 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jul 2017to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that underwent oeosphagectomy at the Norfolk and Norwich Hospital between September 2011 to March 2017
Who may be able to join
- male and female ii. underwent an oesophagectomy iii. completed a pre-operative CPEX test
Who cannot join
- patients that were unable to complete a full CPEX test ii. emergency or palliative surgery iii. pharyngolaryngo-oesophagectomy iv. oesophagectomy and gastrectomy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
About this study
Official title: The Association Between Preoperative Cardiopulmonary Exercise Test Variables and Short-term Postoperative Morbidity Following Oesophagectomy: a Hospital-based Cohort Study
A retrospective hospital-based cohort study of the association between preoperative cardiopulmonary exercise test (CPEX) variables and short-term postoperative morbidity following oesophagectomy.
Read the detailed description
The aim of this study is to examine the correlations between preoperative CPEX variables (VO2max and Anaerobic Threshold) and 30 day postoperative all cause morbidity in a sample large enough to allow (should significant associations exist) calculation of a threshold value. Secondary aims are to examine associations between the VO2max, AT and cardiopulmonary, non-cardiopulmonary complications as well as specific complications (atrial fibrillation, pneumonia, and anastomotic leak) as well as 30 and 90 day mortality.
- Conditions
- Oesophageal Cancer
- Being tested
- Cardiopulmonary exercise testing
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testingDiagnostic test
Aerobic fitness measured using a cycle ergometer and metabolic cart
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause postoperative morbidity
Classified using Esophageal Complications Consensus Group (ECCG) definitions [1] and graded using Clavien-Dindo severity classification [2].
Measured: 30 days
Secondary outcomes (7)
Cardiopulmonary complications
Classified using ECCG definitions and graded using Clavien-Dindo severity classification.
Measured: 30 days
Non-cardiopulmonary complications
Classified using ECCG definitions and graded using Clavien-Dindo severity classification.
Measured: 30 days
Mortality
All cause mortality.
Measured: 30 days
Mortality
All cause mortality.
Measured: 90 days
Pneumonia
Classified using ECCG definitions and graded using Clavien-Dindo severity classification.
Measured: 30 days
Atrial fibrillation
Classified using ECCG definitions and graded using Clavien-Dindo severity classification.
Measured: 30 days
Anastomotic leak
Classified using ECCG definitions and graded using Clavien-Dindo severity classification.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start21 Jul 2017
- Primary completion4 Oct 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216694
- Sponsor's protocol ID
- 222793
- Status last verified
- Apr 2019
- First submitted
- 11 Jul 2017
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Preoperative Cardiopulmonary Exercise Test Variables and Short-term Postoperative Morbidity Following Oesophagectomy: a Hospital-based Cohort Study
- ClinicalTrials.gov ID
- NCT03216694
- Acronym / sponsor ID
- 222793
- Conditions
- Oesophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 4 Oct 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective hospital-based cohort study of the association between preoperative cardiopulmonary exercise test (CPEX) variables and short-term postoperative morbidity following oesophagectomy.
Detailed description
The aim of this study is to examine the correlations between preoperative CPEX variables (VO2max and Anaerobic Threshold) and 30 day postoperative all cause morbidity in a sample large enough to allow (should significant associations exist) calculation of a threshold value. Secondary aims are to examine associations between the VO2max, AT and cardiopulmonary, non-cardiopulmonary complications as well as specific complications (atrial fibrillation, pneumonia, and anastomotic leak) as well as 30 and 90 day mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that underwent oeosphagectomy at the Norfolk and Norwich Hospital between September 2011 to March 2017
Key inclusion criteria (1 listed)
- male and female ii. underwent an oesophagectomy iii. completed a pre-operative CPEX test
Key exclusion criteria (1 listed)
- patients that were unable to complete a full CPEX test ii. emergency or palliative surgery iii. pharyngolaryngo-oesophagectomy iv. oesophagectomy and gastrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testingAerobic fitness measured using a cycle ergometer and metabolic cart | Diagnostic test | – |
Primary outcome
All cause postoperative morbidity
Time frame: 30 days
Classified using Esophageal Complications Consensus Group (ECCG) definitions [1] and graded using Clavien-Dindo severity classification [2].
7 secondary outcomes
Cardiopulmonary complications
Time frame: 30 days
Non-cardiopulmonary complications
Time frame: 30 days
Mortality
Time frame: 30 days
Mortality
Time frame: 90 days
Pneumonia
Time frame: 30 days
Atrial fibrillation
Time frame: 30 days
Anastomotic leak
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- \[1\]Link provided by the sponsor.
- \[2\]Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophageal Cancer, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause postoperative morbidity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.