Clinical trial · Observational
Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE)
Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE): a Multi-methods Study
NCT06440174CI-TRIAL-00109935VALUErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oesophageal Cancer | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients who change treatment management
- timeFrame
- this decision will be made at baseline.
- description
- to determine if using EUS after CT-PET changes management.
Secondary outcomes (3)
- measure
- Number of clinicians and patients who will share their opinions on EUS by a one to one interview with a qualitative researcher.
- timeFrame
- This will take place up to 6 weeks following the EUS at one to one interviews.
- description
- The voluntary one to one interview which patients will consent to on the informed consent form, will be used to identify factors that patients consider when deciding whether EUS should be used. This will take place on Microsoft Teams, hosted by the SCTU qualitative researcher. The interview will be recorded and accurately transcribed and once this has taken place, the interview will be deleted. The anonymised transcript can be stored for up to 10 years with the University of Southampton research data management policy.
- measure
- Number of patients who changed their treatment management following EUS.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged 16 or above with first diagnosis of biopsy-confirmed oesophageal cancer. 2. Referred for EUS examination as part of standard of care investigations. 3. Tumour location in the oesophagus, or gastro-oesophageal junction (Siewert types I-III) 4. MDT decision that patient is potentially curable with radical treatment (e.g., endoscopic treatment, surgery +/- neoadjuvant therapy, or definitive chemoradiotherapy) 5. Prior staging with CT and PET-CT 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 7. Clinical staging of T1-T4, N0-N3, M0 disease 8. Adenocarcinoma or squamous cell carcinoma (SCC) histopathological cell type Exclusion Criteria: 9. Recurrent or residual disease 10. Distant metastatic disease detected before EUS. 11. Previous oesophagectomy or oesophageal radiotherapy 12. Unable to undergo EUS examination. 13. Concurrent malignancy e.g., second primary tumour 14. Other histopathological cell type
References
Publications (1)
- DERIVEDFoley 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 40486070