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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01366261

Enrollment

Registered

2011-06-06

Start date

2008-01-31

Completion date

2011-11-30

Last updated

2011-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Diseases

Keywords

Flex-rigid pleuroscopy, pleural biopsy, pleural effusion, safety, thoracoscopy

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.

Interventions

DEVICEsemirigid thoracoscopy

thoracoscopy with semirigid instrument

DEVICErigid thoracoscopy

thoracoscopy with rigid instrument

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026