Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

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:
NCT01472172
First received: November 9, 2011
Last updated: December 3, 2013
Last verified: December 2013

November 9, 2011
December 3, 2013
February 2010
November 2013   (final data collection date for primary outcome measure)
  • Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine, wheather cryobiopsy specimen can be obtained in each patient
  • Size of biopsy samples [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Size of the biopsy specimens in mm2
  • Quality of the sample [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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

Same as current
Complete list of historical versions of study NCT01472172 on ClinicalTrials.gov Archive Site
Bleeding [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Number of patients with a certain degree of bleeding from biopsy site, described as:

1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resusucitation.

Same as current
Not Provided
Not Provided
 
Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.

The primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. We will assess size, morphological features, immunohistochemistry and diagnostic yield as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.

Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Pleural Effusion
  • Pleural Diseases
Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)
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.
Other Name: Autoclavable cryoprobe 20416-032 (ERBE, Germany)
Experimental: Cryobiopsy
Biopsies 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. The biopsy sample will by extracted by gently pulling of the probe.
Intervention: Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
NCT01472172
Endo-0002
Yes
Aleš Rozman, The University Clinic of Pulmonary and Allergic Diseases Golnik
The University Clinic of Pulmonary and Allergic Diseases Golnik
Not Provided
Principal Investigator: Ales Rozman, MD University Clinic Golnik
The University Clinic of Pulmonary and Allergic Diseases Golnik
December 2013

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