Outcome of Patients Undiagnosed Under Medical Thoracoscopy

NCT01356979 | Completed DMC

• 1 other identifier: 052011/15
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in the diagnosis of pleural diseases. MT has an overall diagnostic yield above 90% for malignant pleural diseases and pleural tuberculosis. However, others who are diagnosed as fibrinous pleuritis make confusion in clinicians. Whether these patients are firmly followed or not ? The investigators do not know the answer of this question. In this study the investigators aimed to investigate the outcome of the patients who are diagnosed as fibrinous pleuritis on MT biopsies.

Conditions

Pleural Diseases

Keywords

Medical thoracoscopy; Pleural effusion; Malignant pleural diseases; Tuberculous pleuritis; Fibrinous pleuritis

Outcome Measures

Primary Outcomes (1)

• Accuracy of medical thoracoscopy for patients diagnosed as fibrinous pleuritis.

  During 2 years after medical thoracoscopy, the diagnostic sensitivity, specificity, positive predictive value and negative predictive value are determined in the patients diagnosed as fibrinous pleuritis.

  2 years

Secondary Outcomes (1)

• To determine the factors which point the false positive diagnosis of fibrinous pleuritis.

  2 years

Study Arms (1)

Patients underwent medical thoracoscopy

Patients who require medical thoracoscopy for undiagnosed exudative pleural effusion by other clinical or radiological investigations.

Procedure: Medical thoracoscopy

Interventions

Medical thoracoscopy PROCEDURE

Performing medical thoracoscopy to diagnose pleural diseases after cytological and other investigational tests.

Also known as: Rigid thoracoscopy for diagnosis of pleural diseases

Patients underwent medical thoracoscopy

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with undiagnosed exudative pelural effusion by clinical, radiological or laboratory investigations.

You may qualify if:

• Undiagnosed exudative pleural effusion
• Under 20 years-old, over 85 years-old
• Followed 2 years at least

You may not qualify if:

• Transudative pleural effusion
• Patients who do not accepted medical thoracoscopy.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

ESOGU Medical Faculty Department of Chest Diseases

Eskişehir, Meselik - Eskisehir, 26040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pleural Diseases; Pleural Effusion; Tuberculosis, Pleural

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Tuberculosis, Extrapulmonary; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections

Study Officials

• Muzaffer Metintas, MD

  ESOGU Medical Faculty Department of Chest Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Prof. in Pulmonary Medicine

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 20, 2011
• Study Start: February 1, 2002
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

TU (1)