Drainage of Tuberculous Pleural Effusions

This study has been completed.
Information provided by:
Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
First received: August 31, 2007
Last updated: December 28, 2010
Last verified: December 2010
Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and to decrease the occurrence of RPT. However, contradictory results are reported without clear reasons. The researchers' hypothesis is that, in addition to anti-TB medications, early effective evacuation of inflammatory exudates with or without fibrinolytic agents may hasten resolution of pleural effusion, reduce the occurrence of RPT and finally improve long-term functional outcome in patients with TB pleurisy.

Condition Intervention
Tuberculous Pleurisy
Procedure: Pigtail drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drainage of Tuberculous Pleural Effusions

Resource links provided by NLM:

Further study details as provided by Taipei Medical University Hospital:

Primary Outcome Measures:
  • Chest radiography, daily monitoring of the volume of fluid drained, the time needed for resolution of fever and dyspnea, and total amounts of fluid drained, and the length of chest drainage and hospitalization [ Time Frame: baseline, daily after treatment within admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Chest radiography and pulmonary function testing with spirometry [ Time Frame: At discharge and at 2, 4, 6, and 12 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: October 2003
Study Completion Date: December 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of tuberculous pleurisy

Exclusion Criteria:

  • History of invasive procedures directed into the pleural cavity
  • Recent severe trauma, hemorrhage, or stroke; bleeding disorder or anticoagulant therapy
  • Use of streptokinase in the previous 2 years
  • Lack of clinical symptoms caused by effusions
  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: NCT00524147

Taipei Medical University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University Hospital
Principal Investigator: Chi-Li Chung, MD Department of Internal Medicine, Taipei Medical University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chi-Li Chung, Department of Internal Medicine, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT00524147     History of Changes
Other Study ID Numbers: TMU92-AE1-B36 
Study First Received: August 31, 2007
Last Updated: December 28, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University Hospital:
loculated pleural effusion
pigtail drainage
pleural effusion
pleural thickening

Additional relevant MeSH terms:
Pleural Effusion
Tuberculosis, Pleural
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 02, 2016