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Drainage of Tuberculous Pleural Effusions

NCT ID: NCT00524147

Last Updated: 2010-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculous Pleurisy

Keywords

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loculated pleural effusion pigtail drainage pleural effusion pleural thickening tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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Pigtail drainage

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Internal Medicine, Taipei Medical University Hospital

Principal Investigators

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Chi-Li Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Taipei Medical University Hospital

Locations

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Taipei Medical University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Chung CL, Chen CH, Yeh CY, Sheu JR, Chang SC. Early effective drainage in the treatment of loculated tuberculous pleurisy. Eur Respir J. 2008 Jun;31(6):1261-7. doi: 10.1183/09031936.00122207. Epub 2008 Jan 23.

Reference Type DERIVED
PMID: 18216051 (View on PubMed)

Other Identifiers

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TMU92-AE1-B36

Identifier Type: -

Identifier Source: org_study_id