A pragmatic randomised controlled trial of the cost-effectiveness of palliative therapies for patients with oesophageal cancer

ISRCTN ISRCTN18914993
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

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
Email none@example.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific titleA pragmatic randomised controlled trial of the cost-effectiveness of palliative therapies for patients with oesophageal cancer
Study objectivesThe 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) studiedCancer (neoplasms): Oesophagus
InterventionOesophageal 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 typeOther
Primary outcome measureRelief 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 measuresNot provided at time of registration.
Overall study start date01/10/1998
Completion date30/09/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants217
Key inclusion criteriaPatients with oesophageal cancer
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/10/1998
Date of final enrolment30/09/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Surgical Gastroenterology Department
Newcastle upon Tyne
NE4 6BE
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.