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

ISRCTN	ISRCTN17262544
DOI	https://doi.org/10.1186/ISRCTN17262544
Secondary identifying numbers	N0063083910

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 20/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr J Lawrance
Scientific

X-Ray Diagnostic
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom

Phone	+44 (0)161 446 3324
Email	Jeremy.Lawrance@christie.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Does intraperitoneal streptokinase enhance the drainage of loculated ascites in patients with ovarian carcinoma?
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(s)	Not provided at time of registration
Condition	Cancer: Ovarian
Intervention	Arm A: Streptokinase Arm B: Placebo via the peritoneal drain
Intervention type	Other
Primary outcome measure	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 study start date	21/07/2000
Overall study end date	25/02/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	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 inclusion criteria	Not provided at time of registration
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

England
United Kingdom

Study participating centre

X-Ray Diagnostic

Manchester
M20 4BX
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Christie Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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