Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

Early Phase 1

Completed

• Conditions: Pleural Effusion; Pleural Diseases
• Interventions: Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)

• Registration Number: NCT01472172
• Lead Sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryobiopsy	Cryobiopsy (Autoclavable cryoprobe 20416-032)	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.

Primary Outcome Measures

Name	Time	Method
Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe	12 months	To determine, wheather cryobiopsy specimen can be obtained in each patient
Size of biopsy samples	12 months	Size of the biopsy specimens in mm2
Quality of the sample	12 months	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

Name	Time	Method
Bleeding	1 month	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.

Trial Locations

Locations (1)

University Clinic Golnik; 🇸🇮 Golnik 36, Golnik, Slovenia