Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 96/06/07
Study information
Scientific title
Acronym
Study hypothesis
The aim of the study is to assist health purchasers in deciding between different palliative therapies for patients with oesophageal cancer. Two new types of oesophageal stent will be compared to other widely used methods of palliation: Insertion of rigid oesophageal endoprostheses and non-stenting endoscopic treatments. A multi-centred pragmatic prospective trial involving six centres and 240 patients is proposed to compare costs and benefits to patients of these therapies in terms of relief of symptoms, incidence of early and late complications and improvement in swallowing ability and quality of life. The study will estimate the total treatment costs to the NHS and demonstrate any differences in clinical effectiveness as well as the most cost-effective palliative therapy for malignant dysphagia when all complications and cost of subsequent additional treatments are taken into account.
Ethics approval
The study was approved by the Multicentre Research and Ethics Committee (MREC) on 8 October 1998 (ref: MREC/98/3/51)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Cancer (neoplasms): Oesophagus
Intervention
Oesophageal cancer. Two new types of oesophageal stent will be compared to other widely used methods of palliation: Insertion of rigid oesophageal endoprostheses and non-stenting endoscopic treatments.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Relief of symptoms, incidence of early and late complications and improvement in swallowing ability and quality of life. The study will also estimate the total treatment costs to the NHS and demonstrate any differences in clinical effectiveness as well as the most cost-effective palliative therapy for malignant dysphagia when all complications and cost of subsequent additional treatments are taken into account.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/10/1998
Overall trial end date
30/09/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with oesophageal cancer
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
217
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/10/1998
Recruitment end date
30/09/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Surgical Gastroenterology Department
Newcastle upon Tyne
NE4 6BE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15717937
Publication citations
-
HTA monograph
Shenfine J, McNamee P, Steen N, Bond J, Griffin SM, A pragmatic randomised controlled trial of the cost-effectiveness of palliative therapies for patients with inoperable oesophageal cancer., Health Technol Assess, 2005, 9, 5, iii, 1-121.