Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE)
VALUE
1 other identifier
observational
160
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2024
CompletedFirst Posted
Study publicly available on registry
June 3, 2024
CompletedStudy Start
First participant enrolled
June 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 30, 2026
April 1, 2026
2 years
May 8, 2024
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients who change treatment management
to determine if using EUS after CT-PET changes management.
this decision will be made at baseline.
Secondary Outcomes (3)
Number of clinicians and patients who will share their opinions on EUS by a one to one interview with a qualitative researcher.
This will take place up to 6 weeks following the EUS at one to one interviews.
Number of patients who changed their treatment management following EUS.
this decision will be made at baseline.
Number of patients who decided on their treatment.
this decision will be made at baseline.
Interventions
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.
Eligibility Criteria
Patients will be recruited through MDTs at participating secondary care centres in the UK. Those deemed suitable will be approached by their care team to take part.
You may qualify if:
- Patients aged 16 or above with first diagnosis of biopsy-confirmed oesophageal cancer.
- Referred for EUS examination as part of standard of care investigations.
- Tumour location in the oesophagus, or gastro-oesophageal junction (Siewert types I-III)
- MDT decision that patient is potentially curable with radical treatment (e.g., endoscopic treatment, surgery +/- neoadjuvant therapy, or definitive chemoradiotherapy)
- Prior staging with CT and PET-CT
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Clinical staging of T1-T4, N0-N3, M0 disease
- Adenocarcinoma or squamous cell carcinoma (SCC) histopathological cell type
You may not qualify if:
- Recurrent or residual disease
- Distant metastatic disease detected before EUS.
- Previous oesophagectomy or oesophageal radiotherapy
- Unable to undergo EUS examination.
- Concurrent malignancy e.g., second primary tumour
- Other histopathological cell type
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Cwm Taf UHB
Abercynon, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Cambridge University NHS Foundation Trust
Cambridge, United Kingdom
Cardiff and Vale UHB
Cardiff, United Kingdom
Velindre University NHS Trust
Cardiff, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Queen's Medical Centre, Nottingham
Nottingham, United Kingdom
Salford Royal Hospital
Salford, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Singleton Hospital, Swansea
Swansea, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Related Publications (1)
Foley KG, Boxall C, Franklin J, Cook A, Underwood T, Griffiths G, Cozens K, Bradbury K, Fay M, Chuter D, Longman KA, Lindfield B, Hurt C. Understanding the variation of modern endoscopic ultrasound use in patients with oesophageal cancer (VALUE): protocol for a multi-methods study. BJR Open. 2025 May 21;7(1):tzaf012. doi: 10.1093/bjro/tzaf012. eCollection 2025 Jan.
PMID: 40486070DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kieran Foley
Chief Investigator, based at Velindre University NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2024
First Posted
June 3, 2024
Study Start
June 27, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share