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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Singapore General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00758316
First received: September 23, 2008
Last updated: June 14, 2011
Last verified: June 2011
  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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014