Back to resultsPleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
Primary Purpose
Pleural Effusion, Pleural Diseases
Status
Completed
Phase
Early Phase 1
Locations
Slovenia
Study Type
Interventional
Intervention
Cryobiopsy (Autoclavable cryoprobe 20416-032)
Sponsored by
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
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
Arm Description
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.
Outcomes
Primary Outcome Measures
Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe
To determine, wheather cryobiopsy specimen can be obtained in each patient
Size of biopsy samples
Size of the biopsy specimens in mm2
Quality of the sample
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
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.
Full Information
NCT ID
NCT01472172
First Posted
November 9, 2011
Last Updated
December 3, 2013
Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
1. Study Identification
Unique Protocol Identification Number
NCT01472172
Brief Title
Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
Official Title
Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (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 determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.
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.
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
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryobiopsy
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Cryobiopsy (Autoclavable cryoprobe 20416-032)
Other Intervention Name(s)
Autoclavable cryoprobe 20416-032 (ERBE, Germany)
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.
Primary Outcome Measure Information:
Title
Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe
Description
To determine, wheather cryobiopsy specimen can be obtained in each patient
Time Frame
12 months
Title
Size of biopsy samples
Description
Size of the biopsy specimens in mm2
Time Frame
12 months
Title
Quality of the sample
Description
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 months
Secondary Outcome Measure Information:
Title
Bleeding
Description
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.
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
Learn more about this trial
Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
We'll reach out to this number within 24 hrs