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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
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusions focused on measuring pleurodesis, talc, iodopovidone

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 1, 2007
Last Updated
February 1, 2007
Sponsor
Postgraduate Institute of Medical Education and Research
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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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