Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

The University Clinic of Pulmonary and Allergic Diseases Golnik

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pleural Effusion; Pleural Diseases

Treatments: Device: cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps

Study type: Interventional

Funder types: Other

Identifiers

NCT01475084

Endo-0003

Details and patient eligibility

About

The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid thoracoscopy.

Full 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.

Enrollment: 40 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: Single Blind

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40 participants in 1 patient group

Cryobiopsy, forceps biopsy

Experimental group

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.

Treatment:

Device: cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps