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
  Purpose

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.


Condition Intervention Phase
Pleural Effusion
Pleural Diseases
Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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.



Enrollment: 15
Study Start Date: February 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)

Detailed Description:

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.

  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
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: NCT01472172

Locations
Slovenia
University Clinic Golnik
Golnik 36, Golnik, Slovenia, 4204
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, Head of endoscopy department, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier: NCT01472172     History of Changes
Other Study ID Numbers: Endo-0002
Study First Received: November 9, 2011
Last Updated: December 3, 2013
Health Authority: Slovenia: Ministry of Health

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 August 01, 2014