Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440174
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-08
Brief Title:
Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer VALUE
Sponsor:
University Hospital Southampton NHS Foundation Trust
Organization:
University Hospital Southampton NHS Foundation Trust
Study Overview
Official Title:
Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer VALUE a Multi-methods Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VALUE
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
Detailed Description:
Over 9000 patients are diagnosed with oesophageal cancer in the United Kingdom UK annually The prognosis of these patients is poor with an overall 5-year survival rate of 15
Most patients 60 present with advanced disease and palliation is the only treatment option Accordingly oesophageal cancer has considerable unmet research need
The VALUE trial is a prospective observational study investigating EUS in the modern era of oesophageal cancer staging A quantitative study component will examine how often and why EUS changes treatment decisions after initial staging with CT and PET-CT A qualitative study component will explore both clinician and patient attitudes and opinions towards the utility of EUS in the staging pathway
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
VALUE aims to recruit patients with oesophageal cancer who are deemed to have potentially curable disease and who are fit for and wish to have radical treatment and who receive EUS as part of their standard of care staging pathway Patients with a range of disease status T1-T4 N0-N3 will be considered for recruitment to allow diverse consideration of the reasons whether EUS impacts treatment decisions in current clinical practice VALUE will also recruit clinicians who regularly care for oesophageal cancer patients in a multi-disciplinary setting to gather their opinions regarding the use of EUS in this patient population
A systematic review updating a prior review found that current evidence concerning the impact of EUS on the management and outcome of oesophageal cancer patients in modern staging with PET-CT was of limited quality In total 18 studies with 11836 patients were included Overall 2805 patients 237 underwent EUS compared to 9031 763 without However only 197 of all patients also had PET-CT for staging Reported change of management by EUS varied widely from 0 to 56
EUS use in oesophageal cancer patients across the NHS is also reported to vary widely Considerable variation in EUS practice was found in a survey of oesophageal cancer multi-disciplinary team MDT leads across the UK Eighty-seven of 97 UK NHS trusts responded 29 recommended EUS for all potentially curable patients whereas 46 requested EUS after PET-CT on a case-by-case basis 20 reported both a lack of utility and concerns about treatment delay Overall 63 and 43 routinely use EUS for radiotherapy and surgical planning respectively Further data from the National Oesophago-Gastric Cancer Audit NOGCA all describe the reported decline in EUS use from 62 of all patients in 2013 to 39 in 2019 and 186 to 2021 In 202021 EUS was used in 236 of patients who had a curative treatment plan
The Cancer of Oesophagus or Gastricus-New Assessment of Technology of Endosonography COGNATE trial randomised patients between EUS with CT and CT alone EUS led to improved quality-adjusted survival However since COGNATE oesophageal cancer staging has been transformed by PET-CT a cross-sectional nuclear imaging test usually performed prior to EUS PET-CT has greater sensitivity for distant metastases than CT and therefore identifies more patients unsuitable for radical treatment meaning that local staging with EUS becomes less critical in these patients
This conclusion is supported by data from a large retrospective cohort study by Findlay et al which included 953 patients of which 798 had EUS and 918 had PET-CT The authors found that patient management was changed by EUS in 11 of cases but when probability thresholds were calculated the utility of EUS in the majority of patients 718 staged T2-T4a was minimal 04 concluding that the risk of EUS exceeded its benefit However these data have not been validated outside of this single-centre study but does question the value of EUS in the modern staging pathway
In summary the use of PET-CT for oesophageal cancer staging is increasing and use of EUS declining which supports the modern tendency of clinicians to favour non-invasive cross-sectional imaging However evidence supporting the basis for this recent change in practice is limited
There will also be a qualitative part of the trial where a qualitative researcher will interview 30 patients who consent to this in the patient information sheet and 30 clinicians who can carry out EUS and ask both for their opinions and thoughts on the procedure
Most patients 60 present with advanced disease and palliation is the only treatment option Accordingly oesophageal cancer has considerable unmet research need
The VALUE trial is a prospective observational study investigating EUS in the modern era of oesophageal cancer staging A quantitative study component will examine how often and why EUS changes treatment decisions after initial staging with CT and PET-CT A qualitative study component will explore both clinician and patient attitudes and opinions towards the utility of EUS in the staging pathway
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
VALUE aims to recruit patients with oesophageal cancer who are deemed to have potentially curable disease and who are fit for and wish to have radical treatment and who receive EUS as part of their standard of care staging pathway Patients with a range of disease status T1-T4 N0-N3 will be considered for recruitment to allow diverse consideration of the reasons whether EUS impacts treatment decisions in current clinical practice VALUE will also recruit clinicians who regularly care for oesophageal cancer patients in a multi-disciplinary setting to gather their opinions regarding the use of EUS in this patient population
A systematic review updating a prior review found that current evidence concerning the impact of EUS on the management and outcome of oesophageal cancer patients in modern staging with PET-CT was of limited quality In total 18 studies with 11836 patients were included Overall 2805 patients 237 underwent EUS compared to 9031 763 without However only 197 of all patients also had PET-CT for staging Reported change of management by EUS varied widely from 0 to 56
EUS use in oesophageal cancer patients across the NHS is also reported to vary widely Considerable variation in EUS practice was found in a survey of oesophageal cancer multi-disciplinary team MDT leads across the UK Eighty-seven of 97 UK NHS trusts responded 29 recommended EUS for all potentially curable patients whereas 46 requested EUS after PET-CT on a case-by-case basis 20 reported both a lack of utility and concerns about treatment delay Overall 63 and 43 routinely use EUS for radiotherapy and surgical planning respectively Further data from the National Oesophago-Gastric Cancer Audit NOGCA all describe the reported decline in EUS use from 62 of all patients in 2013 to 39 in 2019 and 186 to 2021 In 202021 EUS was used in 236 of patients who had a curative treatment plan
The Cancer of Oesophagus or Gastricus-New Assessment of Technology of Endosonography COGNATE trial randomised patients between EUS with CT and CT alone EUS led to improved quality-adjusted survival However since COGNATE oesophageal cancer staging has been transformed by PET-CT a cross-sectional nuclear imaging test usually performed prior to EUS PET-CT has greater sensitivity for distant metastases than CT and therefore identifies more patients unsuitable for radical treatment meaning that local staging with EUS becomes less critical in these patients
This conclusion is supported by data from a large retrospective cohort study by Findlay et al which included 953 patients of which 798 had EUS and 918 had PET-CT The authors found that patient management was changed by EUS in 11 of cases but when probability thresholds were calculated the utility of EUS in the majority of patients 718 staged T2-T4a was minimal 04 concluding that the risk of EUS exceeded its benefit However these data have not been validated outside of this single-centre study but does question the value of EUS in the modern staging pathway
In summary the use of PET-CT for oesophageal cancer staging is increasing and use of EUS declining which supports the modern tendency of clinicians to favour non-invasive cross-sectional imaging However evidence supporting the basis for this recent change in practice is limited
There will also be a qualitative part of the trial where a qualitative researcher will interview 30 patients who consent to this in the patient information sheet and 30 clinicians who can carry out EUS and ask both for their opinions and thoughts on the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None