Condition category
Cancer
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
05/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michael Griffin

ORCID ID

Contact details

Surgical Gastroenterology Department
Newcastle University and The Royal Victoria Infirmary
Westgate Road
Newcastle upon Tyne
NE4 6BE
United Kingdom
+44 (0)191 282 0234

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

2005 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15717937

Publication citations

  1. 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.

Additional files

Editorial Notes