A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis - Tabular View

Tracking Information

First Received Date ^ICMJE

February 1, 2007

Last Updated Date

February 1, 2007

Start Date ^ICMJE

January 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Success
Failure

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Death
Pain by VAS
Time to Pleurodesis
Others

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis

Official Title ^ICMJE

A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Malignant Pleural Effusions
Recurrent Pleural Effusions
Primary Spontaneous Pneumothorax
Secondary Spontaneous Pneumothorax

Intervention ^ICMJE

Procedure: Pleurodesis with either talc or iodopovidone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

100

Completion Date

December 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

India

Administrative Information

NCT ID ^ICMJE

NCT00430664

Responsible Party

Study ID Numbers ^ICMJE

7134-PG-1Tg-05/5469-71

Study Sponsor ^ICMJE

Postgraduate Institute of Medical Education and Research

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Dheeraj Gupta, MD, DM, FCCP

Additional Professor, Dept of Pulmonary Medicine, PGIMER, Chandigarh, India

Information Provided By

Postgraduate Institute of Medical Education and Research

Verification Date

February 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP