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Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

Primary Purpose

Pleural Effusion, Pleural Diseases

Status
Completed
Phase
Phase 2
Locations
Slovenia
Study Type
Interventional
Intervention
cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps
Sponsored by
The University Clinic of Pulmonary and Allergic Diseases Golnik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Effusion focused on measuring Flex-rigid pleuroscopy, cryobiopsy, pleural biopsy, pleural effusion, safety, thoracoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Clinic Golnik

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryobiopsy, forceps biopsy

Arm Description

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.

Outcomes

Primary Outcome Measures

Comparison of forceps biopsy and cryobiopsy samples
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
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.

Full Information

First Posted
November 16, 2011
Last Updated
September 8, 2015
Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
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1. Study Identification

Unique Protocol Identification Number
NCT01475084
Brief Title
Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study
Official Title
Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Pleural Diseases
Keywords
Flex-rigid pleuroscopy, cryobiopsy, pleural biopsy, pleural effusion, safety, thoracoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryobiopsy, forceps biopsy
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps
Other Intervention Name(s)
Autoclavable cryoprobe 20416-032 (ERBE, Germany), Flexible FB-55CD-1 Olympus forceps
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of forceps biopsy and cryobiopsy samples
Description
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
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ales Rozman, MD
Organizational Affiliation
University Clinic Golnik
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Golnik
City
Golnik 36
State/Province
Golnik
ZIP/Postal Code
4204
Country
Slovenia

12. IPD Sharing Statement

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Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

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