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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 31, 2011
First Posted Date  ICMJE June 6, 2011
Last Update Posted Date November 11, 2011
Study Start Date  ICMJE January 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2011)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01366261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2011)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
Official Title  ICMJE Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Pleural Diseases
Intervention  ICMJE
  • Device: semirigid thoracoscopy
    thoracoscopy with semirigid instrument
    Other Name: autoclavable Olympus LTF-160 (Olympus Tokyo, Japan)
  • Device: rigid thoracoscopy
    thoracoscopy with rigid instrument
    Other Name: autoclavable OP EndoEYE WA50120A (Olympus Tokyo, Japan) video thoracoscope
Study Arms  ICMJE
  • 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.
    Intervention: Device: semirigid thoracoscopy
  • 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.
    Intervention: Device: rigid thoracoscopy
Publications * Rozman A, Camlek L, Marc-Malovrh M, Triller N, Kern I. Rigid versus semi-rigid thoracoscopy for the diagnosis of pleural disease: a randomized pilot study. Respirology. 2013 May;18(4):704-10. doi: 10.1111/resp.12066.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2011)
84
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2011)
80
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01366261
Other Study ID Numbers  ICMJE endo-0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik
Study Sponsor  ICMJE Aleš Rozman
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University Clinic of Pulmonary and Allergic Diseases Golnik
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP