Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study

Pleural Diseases Clinical Trial

Official title:

Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366261
• Other study ID #: endo-0001
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2011
• Last updated: November 9, 2011
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 or more years old

• unilateral pleural effusion of unknown origin

• pleural irregularities suspicious for pleural malignancy

• referral for thoracoscopy after less invasive means of diagnosis had failed

Exclusion Criteria:

• uncontrolled bleeding tendency

• unstable cardiovascular status

• severe heart failure

• ECOG performance status 4

• persistent hypoxemia after evacuation of pleural fluid

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pleural Diseases

Intervention

Device:
• semirigid thoracoscopy
thoracoscopy with semirigid instrument
• rigid thoracoscopy
thoracoscopy with rigid instrument

Locations

Country	Name	City	State
Slovenia	University Clinic Golnik	Golnik 36	Golnik

Sponsors (1)

Lead Sponsor	Collaborator
Aleš Rozman

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic adequacy of semirigid thoracoscopy	comparison of diagnostic adequacy of both instruments (number of definitive diagnosis in each group); size of the biopsy specimens in mm2; interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible)	12 months	No
Secondary	safety	Major adverse events: bleeding; infection; reexpansion pulmonary edema; Minor adverse events: transient self-limited fever; pain; prolongued air leak; subcutaneous emphysema; 30-day mortality	1 month	Yes