Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
20/04/2016
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 J Lawrance

ORCID ID

Contact details

X-Ray Diagnostic
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
+44 (0)161 446 3324
Jeremy.Lawrance@christie.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0063083910

Study information

Scientific title

Does intraperitoneal streptokinase enhance the drainage of loculated ascites in patients with ovarian carcinoma?

Acronym

Study hypothesis

To establish the role of fibrinolytic therapy in the management of loculated ascites in metastatic ovarian carcinoma.

Fibrinolysis has been shown to enhance drainage from the pleural space in empysema and loculated pleural effusion (including malignant pleural effusion). Daily instillation of agents such as Streptokinase via a pleural drain is thought to lyse fibrinous septa and hence open loculi to drainage. This occurs without significant local haemorrhagic complications or activation of systemic fibrinolysis.

Occasionally malignant ascites becomes loculated, possibly due to inflammation or haemorrhage from previous drainage procedures, and this greatly hinders future drainage leaving the patient with the discomfort caused by large volume ascites. If fibrinolytics have the same effect in the peritoneal space as in the pleural space this problem could be overcome.

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

Condition

Cancer: Ovarian

Intervention

Arm A: Streptokinase
Arm B: Placebo via the peritoneal drain

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Net volume of ascitic fluid drained post Streptokinase/saline

Secondary outcome measures

1. Change in abdominal girth
2. Ultrasound estimation of residual fluid (largest fluid pocket)
3. Patient symptomatology (subjective change in discomfort)
4. Time interval to reaccumulation of ascites requiring drainage

Overall trial start date

21/07/2000

Overall trial end date

25/02/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

20 NHS patients per year from the Trust split 50%:50% on to standard arm and experimental treatment arm.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

21/07/2000

Recruitment end date

25/02/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

X-Ray Diagnostic
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Christie Hospital 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

20/04/2016: No publications found, verifying study status with principal investigator.