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Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

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ClinicalTrials.gov Identifier: NCT01475084
Recruitment Status : Completed
First Posted : November 21, 2011
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik

Tracking Information
First Submitted Date  ICMJE November 16, 2011
First Posted Date  ICMJE November 21, 2011
Last Update Posted Date September 10, 2015
Study Start Date  ICMJE November 2011
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
Comparison of forceps biopsy and cryobiopsy samples [ Time Frame: 12 month ]
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01475084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2011)
Safety [ Time Frame: 1 month ]
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.
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 Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study
Official Title  ICMJE Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study
Brief Summary The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid thoracoscopy.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pleural Effusion
  • Pleural Diseases
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Device: cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps
Publications * Not Provided

*   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: September 8, 2015)
40
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2011)
25
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (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
  • pleural symphisis, fibrothorax
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 NCT01475084
Other Study ID Numbers  ICMJE Endo-0003
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 The University Clinic of Pulmonary and Allergic Diseases Golnik
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ales Rozman, MD University Clinic Golnik
PRS Account The University Clinic of Pulmonary and Allergic Diseases Golnik
Verification Date September 2015

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