A pragmatic randomised controlled trial of the cost-effectiveness of palliative therapies for patients with oesophageal cancer
ISRCTN | ISRCTN18914993 |
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DOI | https://doi.org/10.1186/ISRCTN18914993 |
Secondary identifying numbers | HTA 96/06/07 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 08/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Michael Griffin
Scientific
Scientific
Surgical Gastroenterology Department
Newcastle University and The Royal Victoria Infirmary
Westgate Road
Newcastle upon Tyne
NE4 6BE
United Kingdom
Phone | +44 (0)191 282 0234 |
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none@example.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
Scientific title | A pragmatic randomised controlled trial of the cost-effectiveness of palliative therapies for patients with oesophageal cancer |
Study objectives | 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(s) | The study was approved by the Multicentre Research and Ethics Committee (MREC) on 8 October 1998 (ref: MREC/98/3/51) |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/10/1998 |
Completion date | 30/09/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Both |
Target number of participants | 217 |
Key inclusion criteria | Patients with oesophageal cancer |
Key exclusion criteria | Not provided at time of registration. |
Date of first enrolment | 01/10/1998 |
Date of final enrolment | 30/09/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Surgical Gastroenterology Department
Newcastle upon Tyne
NE4 6BE
United Kingdom
NE4 6BE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Phone | +44 (0)1132 545 843 |
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Sheila.Greener@doh.gsi.gov.uk | |
Website | http://www.dh.gov.uk/en/index.htm |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | HTA monograph | 01/02/2005 | Yes | No |
Editorial Notes
08/11/2022: Internal review.