Trial Overview

Trial Team

Essential Trial Documentation

Title

Understanding the variation of modern endoscopic ultrasound use in patients with oesophageal cancer (VALUE): a multi-methods study.

Description

Over 9000 patients are diagnosed with oesophageal cancer in the United Kingdom annually. The prognosis of these patients is poor, with an overall 5-year survival rate of 15% and over half of patients present with advanced disease and palliative care is the only treatment option. Therefore, oesophageal cancer has considerable unmet research need. VALUE is an observational study investigating Endoscopic Ultrasound (EUS) in oesophageal cancer staging which will look at both how often and why EUS changes treatment decisions after initial staging and a qualitative component examining clinician and patient attitudes and opinions towards EUS in the staging pathway. This study will open at 11 sites across the UK with a target recruitment of 180 patients, including a qualitative component where 30 clinicians and 30 participants will be invited to an interview to discuss their views and experiences on EUS.

Objectives

Primary:

To determine the proportion of cases in which endoscopic ultrasound (EUS) changes disease management.

Secondary:

To identify factors that clinicians and patients consider when deciding whether EUS should be used.
To determine the reasons why EUS changed the management.
To determine the time from diagnosis to treatment decision before and after EUS.

Trial Design

VALUE trial schema

Trial Status

Open to recruitment.

Population

The target recruitment is 180 patients with 30 of these being invited to an optional interview, following consent to this. 30 clinicians will also be invited to an interview.