RecruitingNCT06440174

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

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrollment

180 participants

Start Date

Jun 27, 2024

Study Type

OBSERVATIONAL

Conditions

Oesophageal Cancer

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.

Eligibility

Min Age: 16 Years

Inclusion Criteria8

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

Exclusion Criteria6

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

Interventions

PROCEDUREendoscopic ultrasound

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.