A Prospective, Randomized Controlled Trial for a Rapid Pleurodesis Protocol for the Management of Pleural Effusions
This study is currently recruiting participants.
Verified June 2011 by Singapore General Hospital
Sponsor:
Singapore General Hospital
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00758316
First received: September 23, 2008
Last updated: June 14, 2011
Last verified: June 2011
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Purpose
Background:
Malignant pleural effusions form a significant proportion of respiratory and oncology work-load. The efficacy of thoracoscopic talc poudrage which is the current standard of care is limited by lung entrapment which prevents lung re-expansion. Thoracoscopy patients also have significant hospital length of stay because chest tube drainage must continue until the pleural space is dry to effect successful pleurodesis.
Alternative management strategies such as tunnelled pleural catheters (bedside ultrasound-guided) enable outpatient management of pleural effusions but have limited pleurodesis rates and do not offer any chance of getting pleural biopsies.
A prospective randomized controlled trial with two arms i.e. thoracoscopic poudrage alone (standard care) versus combined thoracoscopic poudrage and tunnelled pleural catheters. The tunnelled catheters will be inserted at the time of thoracoscopy in the endoscopy centre under ultrasound guidance. The trial is aimed to be completed within 3 years. Primary end-points will be pleurodesis success. The secondary end-points are hospital length-of-stay, complication rates, analgesia requirements, pain scores and quality-of-life scores. Based on power calculations, we aim to recruit 120 patients in each arm.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Pleural Effusions |
Other: Thoracoscopy and Pleurx Procedure: Thoracoscopy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized Controlled Trial for a Rapid Pleurodesis Protocol for the Management of Pleural Effusions |
Resource links provided by NLM:
Further study details as provided by Singapore General Hospital:
Primary Outcome Measures:
- The primary end points will be pleurodesis/pleural catheter success. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hospital length of stay [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Complication rate/analgesia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Talc dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Thoracoscopy with pleurodesis Patients will then undergo standard medical thoracoscopy in the endoscopy center including the use of moderate sedation, prophylactic antibiotics for 1 week and 20F chest tube insertion at the end of the procedure.
|
Procedure: Thoracoscopy
Talc poudrage
Other Name: Pleuroscopy
|
|
Experimental: 2
Combined thoracoscopy with pleurodesis and pleurx catheter. In the combined procedure group, a PleurxTM tunnelled catheter will be inserted under ultrasound guidance. As this procedure will be done concurrently with thoracoscopy, there is no estimated increase in endoscopy time.
|
Other: Thoracoscopy and Pleurx
Talc poudrage and tunneled pleural catheter
Other Name: Pleuroscopy
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients aged ≥ 18 with suspected or known symptomatic malignant pleural effusions (i.e. age >60 or smoking history > 20 pack years or moderate effusion >1/3 hemithorax)
- Ability and willingness to sign informed consent. See Annex 1 for patient information sheet and informed consent form.
- Absence of contraindications to thoracoscopy and tunnelled pleural catheters
- Willingness to comply with follow-up i.e. outpatient follow-up at 1 week and at 1 month for standard intervention; and additional every other day drainage in the intervention group (up to 5 times).
Exclusion criteria:
- Uncorrected coagulopathy with platelet count ≤ 60 and INR ≥ 1.5.
- Uncontrolled coughing because of risk of lung puncture and air leaks
- Severe hypoxemia with a PaO2/FiO2 ratio ≤ 200 or hypercapnia with a PaCO2 ≥ 60 mmHg.
- Unstable cardiovascular status ie. hemodynamic instability requiring inotropes/vasopressors, recent myocardial infarction < 5 days or uncontrolled arrythmias
- Uncontrolled psychiatric disorders or absence of a significant caregiver both of which will contraindicate sending the patient home with a tunnelled catheter
- Previous thoracic surgery/intervention to the affected hemothorax which may have obliterated the pleural space
- Local skin infections that prevent long term catheter placement
- Morbid obesity which will increase risks associated with moderate sedation in the endoscopy centre
- Multi-loculated effusions that will not benefit from drainage
- Suspected pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758316
Contacts
| Contact: Devanand Anantham, FCCP | 6563214700 | anantham.devanand@sgh.com.sg |
Locations
| Singapore | |
| Sinagpore General Hospital | Recruiting |
| Singapore, Singapore, 169608 | |
| Contact: Devanand Anantham, FCCP 6563214700 anantham.devanand@sgh.com.sg | |
| Principal Investigator: Devanand Anantham, FCCP | |
Sponsors and Collaborators
Singapore General Hospital
Investigators
| Principal Investigator: | Devanand Anantham, FCCP | Singapore General Hospital |
More Information
Publications:
| Responsible Party: | Anantham Devanand, Singapore Genearl Hospital |
| ClinicalTrials.gov Identifier: | NCT00758316 History of Changes |
| Other Study ID Numbers: | 149/2008 |
| Study First Received: | September 23, 2008 |
| Last Updated: | June 14, 2011 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Keywords provided by Singapore General Hospital:
|
Malignant Pleural Effusions Thoracoscopy Catheter |
Additional relevant MeSH terms:
|
Pleural Effusion Pleural Effusion, Malignant Pleural Diseases Respiratory Tract Diseases Pleural Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013