A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis
Primary Purpose
Malignant Pleural Effusions, Recurrent Pleural Effusions, Primary Spontaneous Pneumothorax
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Pleurodesis with either talc or iodopovidone
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Pleural Effusions focused on measuring pleurodesis, talc, iodopovidone
Eligibility Criteria
Inclusion Criteria:
- Age over 12 years
- Symptomatic recurrent pleural effusion
- Pneumothorax needing pleurodesis
Exclusion Criteria:
- Life expectancy <1 month
- Unwilling to give consent
- Empyema
- ICTD drain output >150 ml/d
- Presence of an airleak
Sites / Locations
- PGIMERRecruiting
Outcomes
Primary Outcome Measures
Success
Failure
Secondary Outcome Measures
Death
Pain by VAS
Time to Pleurodesis
Others
Full Information
NCT ID
NCT00430664
First Posted
February 1, 2007
Last Updated
February 1, 2007
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00430664
Brief Title
A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis
Official Title
A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
5. Study Description
Brief Summary
Pleurodesis is a technique used to fuse the two layers of the lining over the lung. This is done to get rid of collections of fluid or air in this space. A common reason would be cancer of the underlying lung or elsewhere causing fluid to collect in the pleural space. In this situation it is a palliative procedure to free the patient from symptoms like breathlessness.
Detailed Description
Pleurodesis is a technique used to fuse the two layers of the pleura. This is done to prevent reaccumulation of collections of fluid or air in this space. Common indications are malignant pleural effusions, recurrent pneumothorax and even benign effusions which are otherwise difficult to eradicate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusions, Recurrent Pleural Effusions, Primary Spontaneous Pneumothorax, Secondary Spontaneous Pneumothorax
Keywords
pleurodesis, talc, iodopovidone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pleurodesis with either talc or iodopovidone
Primary Outcome Measure Information:
Title
Success
Title
Failure
Secondary Outcome Measure Information:
Title
Death
Title
Pain by VAS
Title
Time to Pleurodesis
Title
Others
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 12 years
Symptomatic recurrent pleural effusion
Pneumothorax needing pleurodesis
Exclusion Criteria:
Life expectancy <1 month
Unwilling to give consent
Empyema
ICTD drain output >150 ml/d
Presence of an airleak
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dheeraj Gupta, MD, DM, FCCP
Organizational Affiliation
Additional Professor, Dept of Pulmonary Medicine, PGIMER, Chandigarh, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160 012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abinash Paul, MD
Phone
91-9417745955
Email
draspaul@yahoo.co.in
First Name & Middle Initial & Last Name & Degree
Ritesh Agarwal, MD DM
Phone
91- 9815799226
Email
ritesh@indiachest.org
12. IPD Sharing Statement
Learn more about this trial
A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis
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