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A Prospective, Randomized Controlled Trial for a Rapid Pleurodesis Protocol for the Management of Pleural Effusions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758316
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:


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 or disease Intervention/treatment Phase
Malignant Pleural Effusions Other: Thoracoscopy and Pleurx Procedure: Thoracoscopy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Trial for a Rapid Pleurodesis Protocol for the Management of Pleural Effusions
Study Start Date : September 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The primary end points will be pleurodesis/pleural catheter success. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: 1 year ]
  2. Complication rate/analgesia [ Time Frame: 1 year ]
  3. Quality of life [ Time Frame: 1 year ]
  4. Talc dose [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. 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)
  2. Ability and willingness to sign informed consent. See Annex 1 for patient information sheet and informed consent form.
  3. Absence of contraindications to thoracoscopy and tunnelled pleural catheters
  4. 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:

  1. Uncorrected coagulopathy with platelet count ≤ 60 and INR ≥ 1.5.
  2. Uncontrolled coughing because of risk of lung puncture and air leaks
  3. Severe hypoxemia with a PaO2/FiO2 ratio ≤ 200 or hypercapnia with a PaCO2 ≥ 60 mmHg.
  4. Unstable cardiovascular status ie. hemodynamic instability requiring inotropes/vasopressors, recent myocardial infarction < 5 days or uncontrolled arrythmias
  5. Uncontrolled psychiatric disorders or absence of a significant caregiver both of which will contraindicate sending the patient home with a tunnelled catheter
  6. Previous thoracic surgery/intervention to the affected hemothorax which may have obliterated the pleural space
  7. Local skin infections that prevent long term catheter placement
  8. Morbid obesity which will increase risks associated with moderate sedation in the endoscopy centre
  9. Multi-loculated effusions that will not benefit from drainage
  10. Suspected pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00758316

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Sinagpore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
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Principal Investigator: Devanand Anantham, FCCP Singapore General Hospital

Publications of Results:
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Responsible Party: Singapore General Hospital Identifier: NCT00758316    
Other Study ID Numbers: 149/2008
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by Singapore General Hospital:
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site