Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/10/2012
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

Dr Robert J O Davies

ORCID ID

Contact details

Oxford Centre for Respiratory Medicine
Churchill Hospital
Churchill Drive
Headington
Oxford
OX3 7LJ
United Kingdom
+44 (0)1865 225256

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176008571

Study information

Scientific title

Acronym

Study hypothesis

Some patients with cancer become breathless because fluid, repeatedly collects in the space between the lung and the chest wall (the pleural cavity). To control this problem fluid is drained from the cavity and then the walls of the cavity can be 'stuck together' with an irritant solution. This often fails when the fluid in the chest is clollected into separate locules and so the fluid does not drain effectively. This study assesses whether improving the draining of such loculated fluid with streptokinase improves the efficacy of the subsequent irritant solution 'sticking process'.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malignant pleural effusion

Intervention

A randomised controlled trial

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Time to first post pleurodesis aspiration
2. Time to first increase in pleural shadow on chest radiograph
3. Number of patients requiring a further pleural drainage before death or two years follow-up (FU)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/01/1998

Overall trial end date

04/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

40 patients:
1. Confirmed pleural malignancy
2. Recurrent symptomatic pleural effusion
3. Aged 18-85
40 control patients, same criteria.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Previous pleurodesis

Recruitment start date

15/01/1998

Recruitment end date

04/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford Centre for Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Oxford Radcliffe Hospitals NHS Trust (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

Publication citations

Additional files

Editorial Notes