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Completed

NCT Number: NCT01366261

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

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.

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Key information

Conditions

Pleural Diseases Pleural Effusion Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Clinic Golnik

Golnik, 4204, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semirigid thoracoscopy

Device

thoracoscopy with semirigid instrument

Other names: autoclavable Olympus LTF-160 (Olympus Tokyo, Japan)

Rigid thoracoscopy

Device

thoracoscopy with rigid instrument

Other names: autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope

Primary outcomes

  1. diagnostic adequacy of semirigid thoracoscopy

    Time frame: 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 outcomes

  1. safety

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aleš Rozman

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 6, 2011
Registry last updated
Nov 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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