Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

The University Clinic of Pulmonary and Allergic Diseases Golnik

Status and phase: Completed; Early Phase 1

Conditions: Pleural Effusion; Pleural Diseases

Treatments: Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)

Study type: Interventional

Funder types: Other

Identifiers

NCT01472172

Endo-0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Cryobiopsy

Experimental group

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.

Treatment:

Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)