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

This study is currently recruiting participants.

Verified by Postgraduate Institute of Medical Education and Research, February 2007

First Received: February 1, 2007 No Changes Posted

Sponsor:	Postgraduate Institute of Medical Education and Research
Information provided by:	Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:	NCT00430664

Purpose

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.

Condition	Intervention
Malignant Pleural Effusions Recurrent Pleural Effusions Primary Spontaneous Pneumothorax Secondary Spontaneous Pneumothorax	Procedure: Pleurodesis with either talc or iodopovidone

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:

Success
Failure

Secondary Outcome Measures:

Death
Pain by VAS
Time to Pleurodesis
Others

Estimated Enrollment:	100
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2007

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430664

Locations

India
PGIMER	Recruiting
Chandigarh, India, 160 012
Contact: Abinash Paul, MD 91-9417745955 draspaul@yahoo.co.in
Contact: Ritesh Agarwal, MD DM 91- 9815799226 ritesh@indiachest.org

Sponsors and Collaborators

Postgraduate Institute of Medical Education and Research

Investigators

Principal Investigator:

Dheeraj Gupta, MD, DM, FCCP

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

More Information

No publications provided

Study ID Numbers:	7134-PG-1Tg-05/5469-71
Study First Received:	February 1, 2007
Last Updated:	February 1, 2007
ClinicalTrials.gov Identifier:	NCT00430664 History of Changes
Health Authority:	India: Institute Ethics Comittee, PGIMER Chandigarh

Keywords provided by Postgraduate Institute of Medical Education and Research:

pleurodesis
talc
iodopovidone

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Pleural Effusion
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Pleural Diseases
Pleural Effusion, Malignant
Pneumothorax
Pleural Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009