Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06440174 |
| Other study ID # |
CAN1794 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 27, 2024 |
| Est. completion date |
June 30, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
University Hospital Southampton NHS Foundation Trust |
| Contact |
Ben Lindfield |
| Phone |
023 8120 5154 |
| Email |
value[@]soton.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
This is an observational trial that will look at patients undergoing endoscopic ultrasound
(EUS) in patients with oesophageal cancer and to determine the proportion of cases in which
EUS changes disease management in these patients.
Description:
Over 9,000 patients are diagnosed with oesophageal cancer in the United Kingdom (UK)
annually. The prognosis of these patients is poor, with an overall 5-year survival rate of
15%.
Most patients (60%) present with advanced disease and palliation is the only treatment
option. Accordingly, oesophageal cancer has considerable unmet research need.
The VALUE trial is a prospective observational study investigating EUS in the modern era of
oesophageal cancer staging. A quantitative study component will examine how often and why EUS
changes treatment decisions after initial staging with CT and PET-CT. A qualitative study
component will explore both clinician and patient attitudes and opinions towards the utility
of EUS in the staging pathway.
EUS is an invasive procedure combining upper gastrointestinal endoscopy with ultrasonography.
An ultrasound probe located at the end of the endoscope allows direct visualisation of the
oesophageal wall layers and adjacent tissues providing local assessment of the depth of
tumour invasion and lymph nodes. This assessment informs local tumour (T-) and node (N-)
staging which are important prognostic indicators of survival. Patients undergoing EUS
require sedation and there are risks of complication. EUS is a specialist investigation
requiring many years of dedicated training to perform competently.
VALUE aims to recruit patients with oesophageal cancer who are deemed to have potentially
curable disease and who are fit for, and wish to have, radical treatment, and who receive EUS
as part of their standard of care staging pathway. Patients with a range of disease status
(T1-T4; N0-N3) will be considered for recruitment to allow diverse consideration of the
reasons whether EUS impacts treatment decisions in current clinical practice. VALUE will also
recruit clinicians who regularly care for oesophageal cancer patients in a multi-disciplinary
setting to gather their opinions regarding the use of EUS in this patient population.
A systematic review, updating a prior review, found that current evidence concerning the
impact of EUS on the management and outcome of oesophageal cancer patients in modern staging
with PET-CT was of limited quality. In total, 18 studies with 11,836 patients were included.
Overall, 2,805 patients (23.7%) underwent EUS compared to 9,031 (76.3%) without. However,
only 19.7% of all patients also had PET-CT for staging. Reported change of management by EUS
varied widely from 0% to 56%.
EUS use in oesophageal cancer patients across the NHS is also reported to vary widely.
Considerable variation in EUS practice was found in a survey of oesophageal cancer
multi-disciplinary team (MDT) leads across the UK. Eighty-seven of 97 UK NHS trusts
responded. 29% recommended EUS for all potentially curable patients whereas 46% requested EUS
after PET-CT on a case-by-case basis. 20% reported both a lack of utility and concerns about
treatment delay. Overall, 63% and 43% routinely use EUS for radiotherapy and surgical
planning, respectively. Further, data from the National Oesophago-Gastric Cancer Audit
(NOGCA) all describe the reported decline in EUS use from 62% of all patients in 2013, to 39%
in 2019, and 18.6% to 2021. In 2020/21, EUS was used in 23.6% of patients who had a curative
treatment plan.
The Cancer of Oesophagus or Gastricus-New Assessment of Technology of Endosonography
(COGNATE) trial randomised patients between EUS with CT, and CT alone. EUS led to improved
quality-adjusted survival. However, since COGNATE, oesophageal cancer staging has been
transformed by PET-CT, a cross-sectional nuclear imaging test usually performed prior to EUS.
PET-CT has greater sensitivity for distant metastases than CT, and therefore identifies more
patients unsuitable for radical treatment, meaning that local staging with EUS becomes less
critical in these patients.
This conclusion is supported by data from a large retrospective cohort study by Findlay et al
which included 953 patients, of which 798 had EUS, and 918 had PET-CT. The authors found that
patient management was changed by EUS in 11% of cases, but when probability thresholds were
calculated, the utility of EUS in the majority of patients (71.8% staged T2-T4a) was minimal
(0.4%), concluding that the risk of EUS exceeded its benefit. However, these data have not
been validated outside of this single-centre study but does question the value of EUS in the
modern staging pathway.
In summary, the use of PET-CT for oesophageal cancer staging is increasing, and use of EUS
declining, which supports the modern tendency of clinicians to favour non-invasive
cross-sectional imaging. However, evidence supporting the basis for this recent change in
practice is limited.
There will also be a qualitative part of the trial where a qualitative researcher will
interview 30 patients who consent to this in the patient information sheet and 30 clinicians
who can carry out EUS, and ask both for their opinions and thoughts on the procedure.
