Does intraperitoneal streptokinase enhance the drainage of loculated ascites in patients with ovarian carcinoma?
| ISRCTN | ISRCTN17262544 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17262544 |
| Protocol serial number | N0063083910 |
| Sponsor | Department of Health (UK) |
| Funder | Christie Hospital NHS Trust (UK) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr J Lawrance
Scientific
Scientific
X-Ray Diagnostic
Christie Hospital NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
| Phone | +44 (0)161 446 3324 |
|---|---|
| Jeremy.Lawrance@christie.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Does intraperitoneal streptokinase enhance the drainage of loculated ascites in patients with ovarian carcinoma? |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Cancer: Ovarian |
| Intervention | Arm A: Streptokinase Arm B: Placebo via the peritoneal drain |
| Intervention type | Other |
| Primary outcome measure(s) |
Net volume of ascitic fluid drained post Streptokinase/saline |
| Key secondary outcome measure(s) |
1. Change in abdominal girth |
| Completion date | 25/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 20 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 21/07/2000 |
| Date of final enrolment | 25/02/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
X-Ray Diagnostic
Manchester
M20 4BX
United Kingdom
M20 4BX
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 |
Editorial Notes
20/04/2016: No publications found, verifying study status with principal investigator.
