Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorUniversity Hospital Southampton NHS Foundation Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Recurrent or residual disease

Distant metastatic disease detected before EUS.

Previous oesophagectomy or oesophageal radiotherapy

Unable to undergo EUS examination.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • endoscopic ultrasound

    Procedure/Surgery

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Number of patients who change treatment management

to determine if using EUS after CT-PET changes management.

Time frame
this decision will be made at baseline.

Secondary outcomes

1

Number of clinicians and patients who will share their opinions on EUS by a one to one interview with a qualitative researcher.

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.

Time frame
This will take place up to 6 weeks following the EUS at one to one interviews.
2

Number of patients who changed their treatment management following EUS.

to determine the reasons why EUS changed management.

Time frame
this decision will be made at baseline.
3

Number of patients who decided on their treatment.

to determine the time from diagnosis to treatment decision before and after EUS.

Time frame
this decision will be made at baseline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Southampton NHS Foundation Trust

Lead sponsor

National Institute for Health Research, United Kingdom

Collaborator