NCT01193439

Brief Summary

Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes. Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The indication of thoracoscopy in patients with pleural effusion has been optimized. In some studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate of complications. However the investigators do not know its safety on high risk patients. Because many patients having suspected malignancy have bed conditions due to other health problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the investigators aimed to test the safety of medical thoracoscopy in the patients with high risk for complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

7 years

First QC Date

August 26, 2010

Last Update Submit

September 24, 2012

Conditions

Pleural Diseases

Keywords

thoracoscopypleural diseasescomplicationssafety

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    All participants will have been followed for side effects of medical thoracoscopy. All side effects established in the special forms designed for this study. Side effects measured and recorded according to each characteristic such as pain, air leakege, pneumothorax, empyema, local infection, haemorragy etc.

    6 years

Study Arms (2)

Patients with high risk

Patients in normal conditions

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who require thoracoscpic investigation

You may qualify if:

  • Patients with exudative pleural effusion

You may not qualify if:

  • Patients without pleural effusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ESOGU

Eskişehir, Turkey (Türkiye)

Location

Related Publications (1)

  • Rodriguez-Panadero F. Medical thoracoscopy. Respiration. 2008;76(4):363-72. doi: 10.1159/000158545. Epub 2008 Nov 12.

    PMID: 19018161BACKGROUND

MeSH Terms

Conditions

Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Muzaffer Metintas, Professor

    Head of Department, Professor of pulmonary medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 26, 2010

First Posted

September 2, 2010

Study Start

January 1, 2002

Primary Completion

January 1, 2009

Study Completion

December 1, 2010

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

TU(1)