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Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

This study is currently recruiting participants.
Verified November 2011 by The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor:
Information provided by (Responsible Party):
Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier:
NCT01475084
First received: November 16, 2011
Last updated: November 20, 2011
Last verified: November 2011
History of Changes
  Purpose

The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid thoracoscopy.


Condition Intervention Phase
Pleural Effusion
Pleural Diseases
 Device: cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative 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:
  • Comparison of forceps biopsy and cryobiopsy samples [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    • diagnostic yield
    • 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)
    • assessment of biopsy-related artifacts by describing the amount of unaltered tissue in quartiles


Secondary Outcome Measures:
  • Safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    The degree of bleeding at the biopsy site will be assessed as 1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resusucitation.


Estimated Enrollment: 25
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cryobiopsy, forceps biopsy

Cryoiopsies will be obtained by flexible autoclavable cryoprobe 20416-032 (Erbokryo CA, ERBE, Germany) with 2.4 mm in diameter. The tip of the probe is cooled to -890C with nitrous oxide within seconds after footswitch activation.

Forceps biopsies will be obtained by flexible FB-55CD-1 Olympus forceps.

 Device: cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps

The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch for 3 seconds. The frozen tissue is going to be extracted by gently pulling of the probe. The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. The biopsy sample will be released from the probe by thawing in the saline.

Forceps biopsy will be performed on usual way.

Other Names:
  • Autoclavable cryoprobe 20416-032 (ERBE, Germany)
  • Flexible FB-55CD-1 Olympus forceps

Detailed Description:

The investigators are going to compare diagnostic yield and size, morphological features, immunohistochemistry as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.

  Eligibility

Ages Eligible for Study:   18 Years and older
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
  • pleural symphisis, fibrothorax
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475084

Contacts
Contact: Ales Rozman, MD +38641313811 ales.rozman@klinika-golnik.si

Locations
Slovenia
University Clinic Golnik Recruiting
Golnik 36, Golnik, Slovenia, 4204
Contact: Ales Rozman, pulmonology specialist     +386-41-313811     ales.rozman@klinika-golnik.si    
Sub-Investigator: Ales Rozman, pulmonology specialist            
Sponsors and Collaborators
The University Clinic of Pulmonary and Allergic Diseases Golnik
Investigators
Principal Investigator: Ales Rozman, MD University Clinic Golnik
  More Information

No publications provided

Responsible Party: Aleš Rozman, MD, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier: NCT01475084     History of Changes
Other Study ID Numbers: Endo-0003
Study First Received: November 16, 2011
Last Updated: November 20, 2011
Health Authority: Slovenia: Ethics Committee

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

Additional relevant MeSH terms:
Pleural Diseases
Pleural Effusion
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013