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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier:
NCT01366261
First received: May 31, 2011
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose
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 Intervention Phase
Pleural Diseases
 Device: semirigid thoracoscopy
Device: rigid thoracoscopy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University Clinic of Pulmonary and Allergic Diseases Golnik:

Primary Outcome Measures:
  • diagnostic adequacy of semirigid thoracoscopy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    • 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:
  • safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

    Major adverse events:

    • bleeding
    • infection
    • reexpansion pulmonary edema

    Minor adverse events:

    • transient self-limited fever
    • pain
    • prolongued air leak

    • subcutaneous emphysema

      30-day mortality
Enrollment: 84
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366261

Locations
Slovenia
University Clinic Golnik
Golnik 36, Golnik, Slovenia, 4204
Sponsors and Collaborators
Aleš Rozman
  More Information

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 
Study First Received: May 31, 2011
Last Updated: November 9, 2011
Health Authority: Slovenia: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016