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

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ClinicalTrials.gov Identifier: NCT01366261
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : November 11, 2011
Sponsor:
Information provided by (Responsible Party):
Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pleural Diseases Device: semirigid thoracoscopy Device: rigid thoracoscopy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
Study Start Date : January 2008
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: semirigid thoracoscopy
Semirigid instrument which we compare was autoclavable Olympus LTF-160 (Olympus Tokyo, Japan). Handle and its controls were similar to flexible fiberoptic bronchoscope, with the insertion portion composed of 22 cm long rigid part and distal 5 cm flexible tip with angulation range 1600 up / 1300 down. The external diameter of insertion portion was 7 mm with 2,8 mm inner channel diameter. The instrument was compatible with Olympus EVIS Exera 160 and 145 and EVIS 100 and 140 video processors and light sources, otherwise employed in video-bronchoscopy. Forceps, which we used was flexible FB-55CD-1 Olympus forceps with 5 mm long cusps and diameter, which fitted the diameter of inner channel of semirigid thoracoscope.
 Device: semirigid thoracoscopy
thoracoscopy with semirigid instrument
Other Name: autoclavable Olympus LTF-160 (Olympus Tokyo, Japan)
Active Comparator: rigid thoracoscopy
The rigid instrument was autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope. The length of the instrument was 29 cm with 00 direction of view and 700 field of view. The external diameter of the instrument was 10 mm with 5,2 mm inner channel diameter. The instrument was compatible with Olympus Visera OTV-S7V and EVIS Exera II CV-180 video processors. Cusps of rigid forceps had outer diameter 5 mm and length 10 mm.
 Device: rigid thoracoscopy
thoracoscopy with rigid instrument
Other Name: autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366261


Locations
Slovenia
University Clinic Golnik
Golnik 36, Golnik, Slovenia, 4204
Sponsors and Collaborators
Aleš Rozman
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Aleš Rozman, MD, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier: NCT01366261     History of Changes
Other Study ID Numbers: endo-0001
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: November 2011

Keywords provided by Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik:
Flex-rigid pleuroscopy
pleural biopsy
pleural effusion
safety
thoracoscopy

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases