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

Phase 3

Completed

• Conditions: Pleural Diseases

• Registration Number: NCT01366261
• Lead Sponsor: Aleš Rozman

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-09
• Last Update Posted: 2011-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
diagnostic adequacy of semirigid thoracoscopy	12 months	* 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)

Secondary Outcome Measures

Name	Time	Method
safety	1 month	Major adverse events: * bleeding; * infection; * reexpansion pulmonary edema; Minor adverse events: * transient self-limited fever; * pain; * prolongued air leak; * subcutaneous emphysema; 30-day mortality

Trial Locations

Locations (1)

University Clinic Golnik; 🇸🇮 Golnik 36, Golnik, Slovenia