Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

Pleural Effusion Clinical Trial

Official title:

Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472172
• Other study ID #: Endo-0002
• Status: Completed
• Phase: Phase 0
• First received: November 9, 2011
• Last updated: December 3, 2013
• Start date: February 2010
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pleural Diseases
• Pleural Effusion

Intervention

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.

Locations

Country	Name	City	State
Slovenia	University Clinic Golnik	Golnik 36	Golnik

Sponsors (1)

Lead Sponsor	Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe	To determine, wheather cryobiopsy specimen can be obtained in each patient	12 months	No
Primary	Size of biopsy samples	Size of the biopsy specimens in mm2	12 months	No
Primary	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	12 months	No
Secondary	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.	1 month	Yes