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
Protocol serial number	HTA 96/06/07
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	30/09/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Surgical Gastroenterology Department

Newcastle upon Tyne
NE4 6BE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.